← Trials/Trial dossier/NCT02607865
PIONEER 3
CompletedPhase 3Results postedEfficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
Lead sponsor
Asset
Semaglutide
Oral · GLP-1 agonist
Listed sites
242
Recruiting sites
—
Enrollment
1,864
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 7-10.5%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
NCT IDNCT02607865
Org study IDNN9924-4222
Secondary ID2015-001351-71
Secondary IDJAPICJapicCTI-163174
Secondary IDU1111-1168-4339WHO
Timeline
Milestones
Study first posted2015-11-18estimated
Study start2016-02-15actual
Primary completion2017-02-14actual
Study completion2018-03-28actual
Results first posted2020-02-27actual
Last update posted2022-07-20actual
Assets
Investigational agents
Study populations
Who this study enrolls
Type 2 diabetes
Eligibility
Who can enroll
Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Male or female, age at least 18 years at the time of signing informed consent For Japan only: Male or female, age at least 20 years at the time of signing informed consent
•Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of screening
•HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive).
•Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with SU (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 90 days prior to the day of screening
Exclusion criteria
•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). For certain specific countries: Additional specific requirements apply
•Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)
•History of pancreatitis (acute or chronic)
•History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
•Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening
•Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
•Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
•Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
•History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
Endpoints (86)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
26
Glycemic / diabetes
22
Cardiometabolic biomarkers
16
Weight & body composition
14
Patient-reported / QoL
6
Other clinical outcomes
2
Weight & body composition
14 endpointsSecondary/registry result
Change in Body Weight: Week 26
Time frame:Week 0, week 26
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kg | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgIn-trial | -1.2 | — |
| on-treatment without rescue medication | -1.2 | — |
| Oral Semaglutide 7 mgIn-trial | -2.2 | — |
| on-treatment without rescue medication | -2.2 | — |
| Oral Semaglutide 14 mgIn-trial | -3.1 | — |
| on-treatment without rescue medication | -3.2 | — |
| Sitagliptin 100 mgIn-trial | -0.6 | — |
| on-treatment without rescue medication | -0.6 | — |
Mean treatment difference-2.595% CI-3.0 – -2.0p< 0.0001Pattern mixture model
Mean treatment difference-1.695% CI-2.0 – -1.1p< 0.0001Pattern mixture model
Mean treatment difference-0.695% CI-1.1 – -0.1p= 0.0185Pattern mixture model
Mean treatment difference-2.695% CI-3.1 – -2.1p<0.0001MMRM
Mean treatment difference-1.595% CI-2.0 – -1.1p<0.0001MMRM
type Mean treatment difference-0.595% CI-1.0 – -0.1p=0.0257MMRM
Secondary/registry result
Change in Body Weight (kg): Weeks 52 and 78
Time frame:Week 0, week 52, week 78
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kg | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 52 | -1.6 | — |
| Week 78 | -1.8 | — |
| Oral Semaglutide 7 mgWeek 52 | -2.5 | — |
| Week 78 | -2.8 | — |
| Oral Semaglutide 14 mgWeek 52 | -3.5 | — |
| Week 78 | -3.2 | — |
| Sitagliptin 100 mgWeek 52 | -0.7 | — |
| Week 78 | -1.0 | — |
Secondary/registry result
Change in Body Weight (%)
Time frame:Week 0, week 26, week 52, week 78
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percentage change | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -1.23 | — |
| Week 52 | -1.65 | — |
| Week 78 | -1.87 | — |
| Oral Semaglutide 7 mgWeek 26 | -2.36 | — |
| Week 52 | -2.63 | — |
| Week 78 | -2.92 | — |
| Oral Semaglutide 14 mgWeek 26 | -3.44 | — |
| Week 52 | -3.83 | — |
| Week 78 | -3.47 | — |
| Sitagliptin 100 mgWeek 26 | -0.64 | — |
| Week 52 | -0.76 | — |
| Week 78 | -0.99 | — |
Secondary/registry result
Change in BMI
Time frame:Week 0, week 26, week 52, week 78
BMI, change
change from baseline, improvement
Posted result
| Group | Value (mean), Kg/m^2 | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -0.4 | — |
| Week 52 | -0.6 | — |
| Week 78 | -0.7 | — |
| Oral Semaglutide 7 mgWeek 26 | -0.8 | — |
| Week 52 | -0.9 | — |
| Week 78 | -1.0 | — |
| Oral Semaglutide 14 mgWeek 26 | -1.1 | — |
| Week 52 | -1.2 | — |
| Week 78 | -1.1 | — |
| Sitagliptin 100 mgWeek 26 | -0.2 | — |
| Week 52 | -0.3 | — |
| Week 78 | -0.4 | — |
Secondary/registry result
Change in Waist Circumference
Time frame:Week 0, week 26, week 52, week 78
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), cm | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -0.7 | — |
| Week 52 | -1.3 | — |
| Week 78 | -1.2 | — |
| Oral Semaglutide 7 mgWeek 26 | -1.8 | — |
| Week 52 | -2.3 | — |
| Week 78 | -2.4 | — |
| Oral Semaglutide 14 mgWeek 26 | -2.3 | — |
| Week 52 | -2.6 | — |
| Week 78 | -2.4 | — |
| Sitagliptin 100 mgWeek 26 | -0.6 | — |
| Week 52 | -0.5 | — |
| Week 78 | -0.7 | — |
Secondary/registry result
Participants Who Achieve Weight Loss ≥5% (Yes/no)
Time frame:Week 26, week 52, week 78
≥5% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 53 | — |
| Week 26 | 385 | — |
| Week 52 | 66 | — |
| Week 52 | 362 | — |
| Week 78 | 83 | — |
| Week 78 | 342 | — |
| Oral Semaglutide 7 mgWeek 26 | 81 | — |
| Week 26 | 359 | — |
| Week 52 | 118 | — |
| Week 52 | 315 | — |
| Week 78 | 115 | — |
| Week 78 | 310 | — |
| Oral Semaglutide 14 mgWeek 26 | 131 | — |
| Week 26 | 308 | — |
| Week 52 | 147 | — |
| Week 52 | 288 | — |
| Week 78 | 139 | — |
| Week 78 | 289 | — |
| Sitagliptin 100 mgWeek 26 | 45 | — |
| Week 26 | 402 | — |
| Week 52 | 50 | — |
| Week 52 | 387 | — |
| Week 78 | 59 | — |
| Week 78 | 384 | — |
Secondary/registry result
Participants Who Achieve Weight Loss ≥10% (Yes/no)
Time frame:Week 26, week 52, week 78
≥10% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 5 | — |
| Week 26 | 433 | — |
| Week 52 | 13 | — |
| Week 52 | 415 | — |
| Week 78 | 12 | — |
| Week 78 | 413 | — |
| Oral Semaglutide 7 mgWeek 26 | 23 | — |
| Week 26 | 417 | — |
| Week 52 | 31 | — |
| Week 52 | 402 | — |
| Week 78 | 43 | — |
| Week 78 | 382 | — |
| Oral Semaglutide 14 mgWeek 26 | 29 | — |
| Week 26 | 410 | — |
| Week 52 | 48 | — |
| Week 52 | 387 | — |
| Week 78 | 46 | — |
| Week 78 | 382 | — |
| Sitagliptin 100 mgWeek 26 | 8 | — |
| Week 26 | 439 | — |
| Week 52 | 11 | — |
| Week 52 | 426 | — |
| Week 78 | 17 | — |
| Week 78 | 426 | — |
Secondary/protocol endpoint
Change in Body Weight: Week 26
Time frame:Week 0, week 26
Body weight, absolute change (kg)
change from baseline, improvement
Secondary/protocol endpoint
Change in Body Weight (kg): Weeks 52 and 78
Time frame:Week 0, week 52, week 78
Body weight, absolute change (kg)
change from baseline, improvement
Secondary/protocol endpoint
Change in Body Weight (%)
Time frame:Week 0, week 26, week 52, week 78
Body weight, % change
percent change from baseline, improvement
Secondary/protocol endpoint
Change in BMI
Time frame:Week 0, week 26, week 52, week 78
BMI, change
change from baseline, improvement
Secondary/protocol endpoint
Change in Waist Circumference
Time frame:Week 0, week 26, week 52, week 78
Waist circumference, change
change from baseline, improvement
Secondary/protocol endpoint
Participants Who Achieve Weight Loss ≥5% (Yes/no)
Time frame:Week 26, week 52, week 78
≥5% weight-loss responders
threshold achievement, improvement
Secondary/protocol endpoint
Participants Who Achieve Weight Loss ≥10% (Yes/no)
Time frame:Week 26, week 52, week 78
≥10% weight-loss responders
threshold achievement, improvement
Glycemic / diabetes
22 endpointsPrimary/registry result
Change in HbA1c: Week 26
Time frame:Week 0, week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage of HbA1c | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgIn-trial | -0.6 | — |
| On-treatment without rescue medication | -0.6 | — |
| Oral Semaglutide 7 mgIn-trial | -1.1 | — |
| On-treatment without rescue medication | -1.2 | — |
| Oral Semaglutide 14 mgIn-trial | -1.3 | — |
| On-treatment without rescue medication | -1.4 | — |
| Sitagliptin 100 mgIn-trial | -0.8 | — |
| On-treatment without rescue medication | -0.8 | — |
Mean treatment difference-0.595% CI-0.6 – -0.4p< 0.0001Pattern mixture model
Mean treatment difference-0.595% CI-0.6 – -0.4p< 0.0001Pattern mixture model
Mean treatment difference-0.295% CI-0.4 – -0.1p< 0.0001Pattern mixture model
Mean treatment difference-0.395% CI-0.4 – -0.1p< 0.0001Pattern mixture model
Mean treatment difference0.295% CI0.1 – 0.3p= 0.0856Pattern mixture model
Mean treatment difference0.295% CI0.0 – 0.3p= 0.0080Pattern mixture model
Mean treatment difference-0.695% CI-0.7 – -0.5p<0.0001MMRM
Mean treatment difference-0.695% CI-0.7 – -0.5p<0.0001MMRM
Mean treatment difference-0.395% CI-0.4 – -0.2p<0.0001MMRM
Mean treatment difference-0.395% CI-0.4 – -0.2p<0.0001MMRM
Mean treatment difference0.295% CI0.1 – 0.4p=0.3851MMRM
Mean treatment difference0.295% CI0.1 – 0.4p<0.0001MMRM
Primary/protocol endpoint
Change in HbA1c: Week 26
Time frame:Week 0, week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Secondary/registry result
Change in HbA1c: Weeks 52 and 78
Time frame:Week 0, week 52, week 78
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage of HbA1c | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 52 | -0.6 | — |
| Week 78 | -0.6 | — |
| Oral Semaglutide 7 mgWeek 52 | -1.0 | — |
| Week 78 | -0.9 | — |
| Oral Semaglutide 14 mgWeek 52 | -1.2 | — |
| Week 78 | -1.1 | — |
| Sitagliptin 100 mgWeek 52 | -0.7 | — |
| Week 78 | -0.7 | — |
Secondary/registry result
Change in FPG
Time frame:Week 0, week 26, week 52, week 78
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -0.83 | — |
| Week 52 | -0.98 | — |
| Week 78 | -1.07 | — |
| Oral Semaglutide 7 mgWeek 26 | -1.17 | — |
| Week 52 | -1.28 | — |
| Week 78 | -1.11 | — |
| Oral Semaglutide 14 mgWeek 26 | -1.67 | — |
| Week 52 | -1.75 | — |
| Week 78 | -1.65 | — |
| Sitagliptin 100 mgWeek 26 | -0.90 | — |
| Week 52 | -1.03 | — |
| Week 78 | -0.91 | — |
Secondary/registry result
Change in SMPG - Mean 7-point Profile
Time frame:Week 0, week 26, week 52, week 78
change from baseline, improvement
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -1.1 | — |
| Week 52 | -1.3 | — |
| Week 78 | -1.3 | — |
| Oral Semaglutide 7 mgWeek 26 | -1.5 | — |
| Week 52 | -1.5 | — |
| Week 78 | -1.5 | — |
| Oral Semaglutide 14 mgWeek 26 | -1.7 | — |
| Week 52 | -1.8 | — |
| Week 78 | -1.7 | — |
| Sitagliptin 100 mgWeek 26 | -1.2 | — |
| Week 52 | -1.4 | — |
| Week 78 | -1.3 | — |
Secondary/registry result
Change in SMPG - Mean Postprandial Increment Over All Meals
Time frame:Week 0, week 26, week 52, week 78
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -0.4 | — |
| Week 52 | -0.4 | — |
| Week 78 | -0.4 | — |
| Oral Semaglutide 7 mgWeek 26 | -0.4 | — |
| Week 52 | -0.4 | — |
| Week 78 | -0.4 | — |
| Oral Semaglutide 14 mgWeek 26 | -0.6 | — |
| Week 52 | -0.7 | — |
| Week 78 | -0.6 | — |
| Sitagliptin 100 mgWeek 26 | -0.6 | — |
| Week 52 | -0.4 | — |
| Week 78 | -0.6 | — |
Secondary/registry result
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)
Time frame:Week 26, week 52, week 78
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 116 | — |
| Week 26 | 319 | — |
| Week 52 | 113 | — |
| Week 52 | 314 | — |
| Week 78 | 113 | — |
| Week 78 | 308 | — |
| Oral Semaglutide 7 mgWeek 26 | 192 | — |
| Week 26 | 246 | — |
| Week 52 | 168 | — |
| Week 52 | 263 | — |
| Week 78 | 165 | — |
| Week 78 | 259 | — |
| Oral Semaglutide 14 mgWeek 26 | 246 | — |
| Week 26 | 190 | — |
| Week 52 | 238 | — |
| Week 52 | 196 | — |
| Week 78 | 191 | — |
| Week 78 | 234 | — |
| Sitagliptin 100 mgWeek 26 | 144 | — |
| Week 26 | 302 | — |
| Week 52 | 138 | — |
| Week 52 | 298 | — |
| Week 78 | 129 | — |
| Week 78 | 310 | — |
Secondary/registry result
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)
Time frame:Week 26, week 52, week 78
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 55 | — |
| Week 26 | 380 | — |
| Week 52 | 55 | — |
| Week 52 | 372 | — |
| Week 78 | 49 | — |
| Week 78 | 372 | — |
| Oral Semaglutide 7 mgWeek 26 | 116 | — |
| Week 26 | 322 | — |
| Week 52 | 99 | — |
| Week 52 | 332 | — |
| Week 78 | 100 | — |
| Week 78 | 324 | — |
| Oral Semaglutide 14 mgWeek 26 | 161 | — |
| Week 26 | 275 | — |
| Week 52 | 146 | — |
| Week 52 | 288 | — |
| Week 78 | 129 | — |
| Week 78 | 296 | — |
| Sitagliptin 100 mgWeek 26 | 61 | — |
| Week 26 | 385 | — |
| Week 52 | 59 | — |
| Week 52 | 377 | — |
| Week 78 | 60 | — |
| Week 78 | 379 | — |
Secondary/registry result
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)
Time frame:Week 26, week 52, week 78
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 87 | — |
| Week 26 | 348 | — |
| Week 52 | 87 | — |
| Week 52 | 340 | — |
| Week 78 | 85 | — |
| Week 78 | 336 | — |
| Oral Semaglutide 7 mgWeek 26 | 155 | — |
| Week 26 | 283 | — |
| Week 52 | 134 | — |
| Week 52 | 297 | — |
| Week 78 | 136 | — |
| Week 78 | 288 | — |
| Oral Semaglutide 14 mgWeek 26 | 208 | — |
| Week 26 | 228 | — |
| Week 52 | 195 | — |
| Week 52 | 239 | — |
| Week 78 | 151 | — |
| Week 78 | 274 | — |
| Sitagliptin 100 mgWeek 26 | 90 | — |
| Week 26 | 356 | — |
| Week 52 | 87 | — |
| Week 52 | 349 | — |
| Week 78 | 84 | — |
| Week 78 | 355 | — |
Secondary/registry result
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)
Time frame:Week 26, week 52, week 78
threshold achievement, improvement
componentsHbA1c, change, Body weight, % change
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 55 | — |
| Week 26 | 380 | — |
| Week 52 | 73 | — |
| Week 52 | 354 | — |
| Week 78 | 76 | — |
| Week 78 | 345 | — |
| Oral Semaglutide 7 mgWeek 26 | 117 | — |
| Week 26 | 321 | — |
| Week 52 | 106 | — |
| Week 52 | 325 | — |
| Week 78 | 113 | — |
| Week 78 | 311 | — |
| Oral Semaglutide 14 mgWeek 26 | 166 | — |
| Week 26 | 270 | — |
| Week 52 | 164 | — |
| Week 52 | 270 | — |
| Week 78 | 149 | — |
| Week 78 | 276 | — |
| Sitagliptin 100 mgWeek 26 | 43 | — |
| Week 26 | 403 | — |
| Week 52 | 51 | — |
| Week 52 | 385 | — |
| Week 78 | 60 | — |
| Week 78 | 379 | — |
Secondary/registry result
Time to Additional Anti-diabetic Medication
Time frame:Weeks 0-78
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 0 to week 26 | 33 | — |
| Week 0 to week 52 | 137 | — |
| Week 0 to week 78 | 179 | — |
| Oral Semaglutide 7 mgWeek 0 to week 26 | 20 | — |
| Week 0 to week 52 | 86 | — |
| Week 0 to week 78 | 119 | — |
| Oral Semaglutide 14 mgWeek 0 to week 26 | 15 | — |
| Week 0 to week 52 | 51 | — |
| Week 0 to week 78 | 75 | — |
| Sitagliptin 100 mgWeek 0 to week 26 | 20 | — |
| Week 0 to week 52 | 111 | — |
| Week 0 to week 78 | 148 | — |
Hazard Ratio (HR)1.3495% CI1.09 – 1.65p=0.0063Regression, Cox
Hazard Ratio (HR)0.7795% CI0.61 – 0.96p=0.0221Regression, Cox
Hazard Ratio (HR)0.5395% CI0.41 – 0.68p<0.0001Regression, Cox
Secondary/registry result/low confidence
Time to Rescue Medication
Time frame:Weeks 0-78
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 0 to week 26 | 25 | — |
| Week 0 to week 52 | 121 | — |
| Week 0 to week 78 | 160 | — |
| Oral Semaglutide 7 mgWeek 0 to week 26 | 11 | — |
| Week 0 to week 52 | 73 | — |
| Week 0 to week 78 | 103 | — |
| Oral Semaglutide 14 mgWeek 0 to week 26 | 5 | — |
| Week 0 to week 52 | 31 | — |
| Week 0 to week 78 | 47 | — |
| Sitagliptin 100 mgWeek 0 to week 26 | 13 | — |
| Week 0 to week 52 | 94 | — |
| Week 0 to week 78 | 129 | — |
Hazard Ratio (HR)1.3395% CI1.05 – 1.68p=0.0160Regression, Cox
Hazard Ratio (HR)0.6695% CI0.51 – 0.86p=0.0022Regression, Cox
Hazard Ratio (HR)0.3195% CI0.22 – 0.43p<0.0001Regression, Cox
Secondary/protocol endpoint
Change in HbA1c: Weeks 52 and 78
Time frame:Week 0, week 52, week 78
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Secondary/protocol endpoint
Change in FPG
Time frame:Week 0, week 26, week 52, week 78
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Secondary/protocol endpoint
Change in SMPG - Mean 7-point Profile
Time frame:Week 0, week 26, week 52, week 78
Postprandial glucose
change from baseline, improvement
Secondary/protocol endpoint
Change in SMPG - Mean Postprandial Increment Over All Meals
Time frame:Week 0, week 26, week 52, week 78
Postprandial glucose
change from baseline, improvement
Secondary/protocol endpoint
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)
Time frame:Week 26, week 52, week 78
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Secondary/protocol endpoint
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)
Time frame:Week 26, week 52, week 78
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Secondary/protocol endpoint
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)
Time frame:Week 26, week 52, week 78
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Secondary/protocol endpoint
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)
Time frame:Week 26, week 52, week 78
threshold achievement, improvement
componentsHbA1c, change, Body weight, % change
Secondary/protocol endpoint
Time to Additional Anti-diabetic Medication
Time frame:Weeks 0-78
event count, event
Secondary/protocol endpoint
Time to Rescue Medication
Time frame:Weeks 0-78
time to event, event
Cardiometabolic biomarkers
16 endpointsSecondary/registry result
Change in Total Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Value (geometric_mean), Ratio of total cholesterol | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.00 | — |
| Week 52 | 1.00 | — |
| Week 78 | 1.00 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.98 | — |
| Week 52 | 0.99 | — |
| Week 78 | 0.99 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.97 | — |
| Week 52 | 0.98 | — |
| Week 78 | 0.99 | — |
| Sitagliptin 100 mgWeek 26 | 1.00 | — |
| Week 52 | 1.01 | — |
| Week 78 | 1.00 | — |
Secondary/registry result
Change in LDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
LDL-C, change
ratio, improvement
LOINC 13457-7
Posted result
| Group | Value (geometric_mean), Ratio of LDL cholesterol | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.02 | — |
| Week 52 | 1.02 | — |
| Week 78 | 1.03 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.98 | — |
| Week 52 | 0.99 | — |
| Week 78 | 1.00 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.98 | — |
| Week 52 | 0.99 | — |
| Week 78 | 1.00 | — |
| Sitagliptin 100 mgWeek 26 | 1.02 | — |
| Week 52 | 1.03 | — |
| Week 78 | 1.03 | — |
Secondary/registry result
Change in VLDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
VLDL, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of VLDL cholesterol | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.99 | — |
| Week 52 | 1.00 | — |
| Week 78 | 0.95 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.96 | — |
| Week 52 | 0.98 | — |
| Week 78 | 0.94 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.91 | — |
| Week 52 | 0.93 | — |
| Week 78 | 0.91 | — |
| Sitagliptin 100 mgWeek 26 | 0.97 | — |
| Week 52 | 0.98 | — |
| Week 78 | 0.94 | — |
Secondary/registry result
Change in HDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
HDL-C, change
ratio, improvement
LOINC 2085-9
Posted result
| Group | Value (geometric_mean), Ratio of HDL cholesterol | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.97 | — |
| Week 52 | 0.99 | — |
| Week 78 | 0.97 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.99 | — |
| Week 52 | 1.01 | — |
| Week 78 | 0.99 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.98 | — |
| Week 52 | 1.01 | — |
| Week 78 | 1.00 | — |
| Sitagliptin 100 mgWeek 26 | 0.99 | — |
| Week 52 | 0.99 | — |
| Week 78 | 0.99 | — |
Secondary/registry result
Change in Triglycerides (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Value (geometric_mean), Ratio of triglycerides | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.99 | — |
| Week 52 | 1.00 | — |
| Week 78 | 0.95 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.96 | — |
| Week 52 | 0.97 | — |
| Week 78 | 0.94 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.92 | — |
| Week 52 | 0.93 | — |
| Week 78 | 0.92 | — |
| Sitagliptin 100 mgWeek 26 | 0.97 | — |
| Week 52 | 0.98 | — |
| Week 78 | 0.93 | — |
Secondary/registry result
Change in Free Fatty Acids (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
Free fatty acids, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of FFA | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.96 | — |
| Week 52 | 1.03 | — |
| Week 78 | 0.92 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.91 | — |
| Week 52 | 1.00 | — |
| Week 78 | 0.87 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.88 | — |
| Week 52 | 0.96 | — |
| Week 78 | 0.88 | — |
| Sitagliptin 100 mgWeek 26 | 0.90 | — |
| Week 52 | 0.98 | — |
| Week 78 | 0.87 | — |
Secondary/registry result
Change in Pulse Rate
Time frame:Week 0, week 26, week 52, week 78
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), Beats/minute | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1 | — |
| Week 52 | 0 | — |
| Week 78 | 1 | — |
| Oral Semaglutide 7 mgWeek 26 | 2 | — |
| Week 52 | 2 | — |
| Week 78 | 1 | — |
| Oral Semaglutide 14 mgWeek 26 | 3 | — |
| Week 52 | 2 | — |
| Week 78 | 2 | — |
| Sitagliptin 100 mgWeek 26 | 0 | — |
| Week 52 | -0 | — |
| Week 78 | 0 | — |
Secondary/registry result
Change in SBP and DBP
Time frame:Week 0, week 26, week 52, week 78
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgSBP: Week 26 | -2 | — |
| SBP: Week 52 | -2 | — |
| SBP: Week 78 | -2 | — |
| DBP: Week 26 | -1 | — |
| DBP: Week 52 | -2 | — |
| DBP: Week 78 | -1 | — |
| Oral Semaglutide 7 mgSBP: Week 26 | -2 | — |
| SBP: Week 52 | -4 | — |
| SBP: Week 78 | -3 | — |
| DBP: Week 26 | -0 | — |
| DBP: Week 52 | -1 | — |
| DBP: Week 78 | -1 | — |
| Oral Semaglutide 14 mgSBP: Week 26 | -3 | — |
| SBP: Week 52 | -3 | — |
| SBP: Week 78 | -3 | — |
| DBP: Week 26 | -1 | — |
| DBP: Week 52 | -1 | — |
| DBP: Week 78 | -1 | — |
| Sitagliptin 100 mgSBP: Week 26 | -2 | — |
| SBP: Week 52 | -1 | — |
| SBP: Week 78 | 0 | — |
| DBP: Week 26 | -0 | — |
| DBP: Week 52 | -1 | — |
| DBP: Week 78 | -1 | — |
Secondary/protocol endpoint
Change in Total Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Secondary/protocol endpoint
Change in LDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
LDL-C, change
ratio, improvement
LOINC 13457-7
Secondary/protocol endpoint
Change in VLDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
VLDL, change
ratio, improvement
Secondary/protocol endpoint
Change in HDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
HDL-C, change
ratio, improvement
LOINC 2085-9
Secondary/protocol endpoint
Change in Triglycerides (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
Triglycerides, change
ratio, improvement
LOINC 2571-8
Secondary/protocol endpoint
Change in Free Fatty Acids (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
Free fatty acids, change
ratio, improvement
Secondary/protocol endpoint
Change in Pulse Rate
Time frame:Week 0, week 26, week 52, week 78
Heart rate, change
change from baseline, improvement
Secondary/protocol endpoint
Change in SBP and DBP
Time frame:Week 0, week 26, week 52, week 78
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Patient-reported / QoL
6 endpointsSecondary/registry result
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)
Time frame:Week 0, week 26, week 52, week 78
SF-36 total
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg1) Physical functioning (week 26) | 0.37 | — |
| 1) Physical functioning (week 52) | 0.29 | — |
| 1) Physical functioning (week 78) | 0.06 | — |
| 2) Role-Physical (week 26) | 0.42 | — |
| 2) Role-Physical (week 52) | -0.05 | — |
| 2) Role-Physical (week 78) | 0.28 | — |
| 3) Bodily pain (week 26) | 0.56 | — |
| 3) Bodily pain (week 52) | 0.16 | — |
| 3) Bodily pain (week 78) | 0.48 | — |
| 4) General health (week 26) | 1.17 | — |
| 4) General health (week 52) | 1.06 | — |
| 4) General health (week 78) | 1.02 | — |
| 5) Vitality (week 26) | 0.59 | — |
| 5) Vitality (week 52) | 0.45 | — |
| 5) Vitality (week 78) | 1.05 | — |
| 6) Social functioning (week 26) | 0.11 | — |
| 6) Social functioning (week 52) | -0.25 | — |
| 6) Social functioning (week 78) | -0.38 | — |
| 7) Role emotional (week 26) | 0.84 | — |
| 7) Role emotional (week 52) | 0.15 | — |
| 7) Role emotional (week 78) | 0.32 | — |
| 8) Mental health (week 26) | 0.33 | — |
| 8) Mental health (week 52) | 0.45 | — |
| 8) Mental health (week 78) | 0.19 | — |
| Physical component summary (week 26) | 0.56 | — |
| Physical component summary (week 52) | 0.31 | — |
| Physical component summary (week 78) | 0.46 | — |
| Mental component summary (week 26) | 0.48 | — |
| Mental component summary (week 52) | 0.23 | — |
| Mental component summary (week 78) | 0.27 | — |
| Oral Semaglutide 7 mg1) Physical functioning (week 26) | 1.12 | — |
| 1) Physical functioning (week 52) | 0.64 | — |
| 1) Physical functioning (week 78) | 0.94 | — |
| 2) Role-Physical (week 26) | 0.76 | — |
| 2) Role-Physical (week 52) | -0.06 | — |
| 2) Role-Physical (week 78) | -0.01 | — |
| 3) Bodily pain (week 26) | -0.11 | — |
| 3) Bodily pain (week 52) | -0.65 | — |
| 3) Bodily pain (week 78) | 0.32 | — |
| 4) General health (week 26) | 1.67 | — |
| 4) General health (week 52) | 1.20 | — |
| 4) General health (week 78) | 1.21 | — |
| 5) Vitality (week 26) | 1.11 | — |
| 5) Vitality (week 52) | 0.79 | — |
| 5) Vitality (week 78) | 0.85 | — |
| 6) Social functioning (week 26) | 0.15 | — |
| 6) Social functioning (week 52) | -0.37 | — |
| 6) Social functioning (week 78) | 0.19 | — |
| 7) Role emotional (week 26) | 0.67 | — |
| 7) Role emotional (week 52) | -0.45 | — |
| 7) Role emotional (week 78) | 0.23 | — |
| 8) Mental health (week 26) | 0.24 | — |
| 8) Mental health (week 52) | 0.42 | — |
| 8) Mental health (week 78) | 0.29 | — |
| Physical component summary (week 26) | 0.98 | — |
| Physical component summary (week 52) | 0.36 | — |
| Physical component summary (week 78) | 0.71 | — |
| Mental component summary (week 26) | 0.34 | — |
| Mental component summary (week 52) | -0.00 | — |
| Mental component summary (week 78) | 0.23 | — |
| Oral Semaglutide 14 mg1) Physical functioning (week 26) | 0.63 | — |
| 1) Physical functioning (week 52) | 0.36 | — |
| 1) Physical functioning (week 78) | 0.54 | — |
| 2) Role-Physical (week 26) | -0.13 | — |
| 2) Role-Physical (week 52) | -0.82 | — |
| 2) Role-Physical (week 78) | -0.33 | — |
| 3) Bodily pain (week 26) | 0.22 | — |
| 3) Bodily pain (week 52) | -0.64 | — |
| 3) Bodily pain (week 78) | 0.74 | — |
| 4) General health (week 26) | 1.19 | — |
| 4) General health (week 52) | 1.03 | — |
| 4) General health (week 78) | 1.21 | — |
| 5) Vitality (week 26) | 0.88 | — |
| 5) Vitality (week 52) | 0.58 | — |
| 5) Vitality (week 78) | 0.71 | — |
| 6) Social functioning (week 26) | 0.31 | — |
| 6) Social functioning (week 52) | -0.83 | — |
| 6) Social functioning (week 78) | -0.27 | — |
| 7) Role emotional (week 26) | -0.37 | — |
| 7) Role emotional (week 52) | -0.86 | — |
| 7) Role emotional (week 78) | -0.30 | — |
| 8) Mental health (week 26) | 0.24 | — |
| 8) Mental health (week 52) | 0.05 | — |
| 8) Mental health (week 78) | 0.28 | — |
| Physical component summary (week 26) | 0.63 | — |
| Physical component summary (week 52) | 0.09 | — |
| Physical component summary (week 78) | 0.67 | — |
| Mental component summary (week 26) | 0.08 | — |
| Mental component summary (week 52) | -0.37 | — |
| Mental component summary (week 78) | -0.07 | — |
| Sitagliptin 100 mg1) Physical functioning (week 26) | 0.46 | — |
| 1) Physical functioning (week 52) | 0.06 | — |
| 1) Physical functioning (week 78) | 0.09 | — |
| 2) Role-Physical (week 26) | 0.38 | — |
| 2) Role-Physical (week 52) | -0.69 | — |
| 2) Role-Physical (week 78) | 0.44 | — |
| 3) Bodily pain (week 26) | 0.44 | — |
| 3) Bodily pain (week 52) | 0.67 | — |
| 3) Bodily pain (week 78) | 0.54 | — |
| 4) General health (week 26) | 1.42 | — |
| 4) General health (week 52) | 0.95 | — |
| 4) General health (week 78) | 1.32 | — |
| 5) Vitality (week 26) | 1.03 | — |
| 5) Vitality (week 52) | 0.19 | — |
| 5) Vitality (week 78) | 1.07 | — |
| 6) Social functioning (week 26) | 0.09 | — |
| 6) Social functioning (week 52) | -0.68 | — |
| 6) Social functioning (week 78) | 0.57 | — |
| 7) Role emotional (week 26) | 0.15 | — |
| 7) Role emotional (week 52) | -0.63 | — |
| 7) Role emotional (week 78) | -0.24 | — |
| 8) Mental health (week 26) | 0.61 | — |
| 8) Mental health (week 52) | 0.23 | — |
| 8) Mental health (week 78) | 0.30 | — |
| Physical component summary (week 26) | 0.69 | — |
| Physical component summary (week 52) | 0.31 | — |
| Physical component summary (week 78) | 0.70 | — |
| Mental component summary (week 26) | 0.41 | — |
| Mental component summary (week 52) | -0.31 | — |
| Mental component summary (week 78) | 0.30 | — |
Secondary/registry result
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains
Time frame:Week 0, week 26, week 52, week 78
IWQOL-Lite total
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg1) Physical (week 26) | 3.25 | — |
| 1) Physical (week 52) | 1.84 | — |
| 1) Physical (week 78) | 2.71 | — |
| 2) Physical function (week 26) | 3.52 | — |
| 2) Physical function (week 52) | 2.28 | — |
| 2) Physical function (week 78) | 2.55 | — |
| 3) Pain/discomfort (week 26) | 2.51 | — |
| 3) Pain/discomfort (week 52) | 0.76 | — |
| 3) Pain/discomfort (week 78) | 3.06 | — |
| 4) Psychosocial (week 26) | 2.69 | — |
| 4) Psychosocial (week 52) | 3.12 | — |
| 4) Psychosocial (week 78) | 3.83 | — |
| IWQOL-Lite-CT Total (week 26) | 2.88 | — |
| IWQOL-Lite-CT Total (week 52) | 2.67 | — |
| IWQOL-Lite-CT Total (week 78) | 3.45 | — |
| Oral Semaglutide 7 mg1) Physical (week 26) | 2.38 | — |
| 1) Physical (week 52) | 3.03 | — |
| 1) Physical (week 78) | 3.55 | — |
| 2) Physical function (week 26) | 2.78 | — |
| 2) Physical function (week 52) | 3.24 | — |
| 2) Physical function (week 78) | 4.04 | — |
| 3) Pain/discomfort (week 26) | 1.37 | — |
| 3) Pain/discomfort (week 52) | 2.52 | — |
| 3) Pain/discomfort (week 78) | 2.35 | — |
| 4) Psychosocial (week 26) | 4.30 | — |
| 4) Psychosocial (week 52) | 5.19 | — |
| 4) Psychosocial (week 78) | 5.36 | — |
| IWQOL-Lite-CT Total (week 26) | 3.62 | — |
| IWQOL-Lite-CT Total (week 52) | 4.43 | — |
| IWQOL-Lite-CT Total (week 78) | 4.73 | — |
| Oral Semaglutide 14 mg1) Physical (week 26) | 2.87 | — |
| 1) Physical (week 52) | 3.18 | — |
| 1) Physical (week 78) | 3.86 | — |
| 2) Physical function (week 26) | 3.20 | — |
| 2) Physical function (week 52) | 3.19 | — |
| 2) Physical function (week 78) | 3.76 | — |
| 3) Pain/discomfort (week 26) | 2.03 | — |
| 3) Pain/discomfort (week 52) | 3.15 | — |
| 3) Pain/discomfort (week 78) | 4.07 | — |
| 4) Psychosocial (week 26) | 2.98 | — |
| 4) Psychosocial (week 52) | 3.97 | — |
| 4) Psychosocial (week 78) | 3.73 | — |
| IWQOL-Lite-CT Total (week 26) | 2.95 | — |
| IWQOL-Lite-CT Total (week 52) | 3.64 | — |
| IWQOL-Lite-CT Total (week 78) | 3.77 | — |
| Sitagliptin 100 mg1) Physical (week 26) | 1.97 | — |
| 1) Physical (week 52) | 1.49 | — |
| 1) Physical (week 78) | 2.86 | — |
| 2) Physical function (week 26) | 1.70 | — |
| 2) Physical function (week 52) | 1.22 | — |
| 2) Physical function (week 78) | 2.54 | — |
| 3) Pain/discomfort (week 26) | 2.66 | — |
| 3) Pain/discomfort (week 52) | 2.12 | — |
| 3) Pain/discomfort (week 78) | 3.63 | — |
| 4) Psychosocial (week 26) | 2.10 | — |
| 4) Psychosocial (week 52) | 2.53 | — |
| 4) Psychosocial (week 78) | 3.29 | — |
| IWQOL-Lite-CT Total (week 26) | 2.05 | — |
| IWQOL-Lite-CT Total (week 52) | 2.17 | — |
| IWQOL-Lite-CT Total (week 78) | 3.16 | — |
Secondary/registry result
Change in CoEQ: Scores From the 4 Domains and the 19 Items
Time frame:Week 0, week 26, week 52, week 78
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg1) Feeling of hunger (wk 26) | -0.41 | — |
| 1) Feeling of hunger (wk 52) | -0.28 | — |
| 1) Feeling of hunger (wk 78) | -0.31 | — |
| 2) Feeling of fullness (wk 26) | -0.08 | — |
| 2) Feeling of fullness (wk 52) | -0.02 | — |
| 2) Feeling of fullness (wk 78) | -0.03 | — |
| 3) Desire to eat sweet foods (wk 26) | -0.41 | — |
| 3) Desire to eat sweet foods (wk 52) | -0.31 | — |
| 3) Desire to eat sweet foods (wk 78) | -0.38 | — |
| 4) Desire to eat savoury foods (wk 26) | -0.27 | — |
| 4) Desire to eat savoury foods (wk 52) | -0.27 | — |
| 4) Desire to eat savoury foods (wk 78) | -0.39 | — |
| 5) Feeling of happiness (wk 26) | 0.01 | — |
| 5) Feeling of happiness (wk 52) | 0.09 | — |
| 5) Feeling of happiness (wk 78) | -0.05 | — |
| 6) Feeling of anxiousness (wk 26) | 0.02 | — |
| 6) Feeling of anxiousness (wk 52) | -0.05 | — |
| 6) Feeling of anxiousness (wk 78) | 0.05 | — |
| 7) Feeling of alertness (wk 26) | 0.11 | — |
| 7) Feeling of alertness (wk 52) | 0.01 | — |
| 7) Feeling of alertness (wk 78) | 0.10 | — |
| 8) Feeling of contentment (wk 26) | 0.05 | — |
| 8) Feeling of contentment (wk 52) | 0.04 | — |
| 8) Feeling of contentment (wk 78) | -0.04 | — |
| 9) Food cravings during last 7 days (wk 26) | -0.59 | — |
| 9) Food cravings during last 7 days (wk 52) | -0.40 | — |
| 9) Food cravings during last 7 days (wk 78) | -0.47 | — |
| 10) Strength of food cravings (wk 26) | -0.50 | — |
| 10) Strength of food cravings (wk 52) | -0.23 | — |
| 10) Strength of food cravings (wk 78) | -0.20 | — |
| 11) Difficulty to resist food cravings (wk 26) | -0.46 | — |
| 11) Difficulty to resist food cravings (wk 52) | 0.00 | — |
| 11) Difficulty to resist food cravings (wk 78) | -0.04 | — |
| 12) Eating in response to food cravings (wk 26) | -0.40 | — |
| 12) Eating in response to food cravings (wk 52) | -0.04 | — |
| 12) Eating in response to food cravings (wk 78) | -0.02 | — |
| 13) Cravings for chocolate (wk 26) | -0.27 | — |
| 13) Cravings for chocolate (wk 52) | -0.28 | — |
| 13) Cravings for chocolate (wk 78) | -0.08 | — |
| 14) Cravings for other sweet foods (wk 26) | -0.33 | — |
| 14) Cravings for other sweet foods (wk 52) | -0.33 | — |
| 14) Cravings for other sweet foods (wk 78) | -0.20 | — |
| 15) Cravings for fruit or fruit juice (wk 26) | -0.20 | — |
| 15) Cravings for fruit or fruit juice (wk 52) | -0.40 | — |
| 15) Cravings for fruit or fruit juice (wk 78) | -0.14 | — |
| 16) Cravings for dairy foods (wk 26) | -0.23 | — |
| 16) Cravings for dairy foods (wk 52) | -0.42 | — |
| 16) Cravings for dairy foods (wk 78) | -0.30 | — |
| 17) Cravings for starchy foods (wk 26) | -0.42 | — |
| 17) Cravings for starchy foods (wk 52) | -0.54 | — |
| 17) Cravings for starchy foods (wk 78) | -0.44 | — |
| 18) Cravings for savoury foods (wk 26) | -0.41 | — |
| 18) Cravings for savoury foods (wk 52) | -0.41 | — |
| 18) Cravings for savoury foods (wk 78) | -0.27 | — |
| 19) Difficulty to control eating in general(wk 26) | -0.47 | — |
| 19) Difficulty to control eating in general(wk 52) | -0.32 | — |
| 19) Difficulty to control eating in general(wk 78) | -0.40 | — |
| Craving control: items 9-12, 19 (wk 26) | 0.49 | — |
| Craving control: items 9-12, 19 (wk 52) | 0.20 | — |
| Craving control: items 9-12, 19 (wk 78) | 0.22 | — |
| Positive mood: items 5-8 (wk 26) | 0.04 | — |
| Positive mood: items 5-8 (wk 52) | 0.04 | — |
| Positive mood: items 5-8 (wk 78) | -0.01 | — |
| Craving for savoury: items 4, 16-18 (wk 26) | -0.33 | — |
| Craving for savoury: items 4, 16-18 (wk 52) | -0.41 | — |
| Craving for savoury: items 4, 16-18 (wk 78) | -0.35 | — |
| Craving for sweet: items 3, 13-15 (wk 26) | -0.30 | — |
| Craving for sweet: items 3, 13-15 (wk 52) | -0.33 | — |
| Craving for sweet: items 3, 13-15 (wk 78) | -0.20 | — |
| Oral Semaglutide 7 mg1) Feeling of hunger (wk 26) | -0.37 | — |
| 1) Feeling of hunger (wk 52) | -0.23 | — |
| 1) Feeling of hunger (wk 78) | -0.22 | — |
| 2) Feeling of fullness (wk 26) | -0.08 | — |
| 2) Feeling of fullness (wk 52) | -0.07 | — |
| 2) Feeling of fullness (wk 78) | -0.09 | — |
| 3) Desire to eat sweet foods (wk 26) | -0.54 | — |
| 3) Desire to eat sweet foods (wk 52) | -0.31 | — |
| 3) Desire to eat sweet foods (wk 78) | -0.42 | — |
| 4) Desire to eat savoury foods (wk 26) | -0.16 | — |
| 4) Desire to eat savoury foods (wk 52) | -0.21 | — |
| 4) Desire to eat savoury foods (wk 78) | -0.39 | — |
| 5) Feeling of happiness (wk 26) | 0.03 | — |
| 5) Feeling of happiness (wk 52) | 0.04 | — |
| 5) Feeling of happiness (wk 78) | -0.08 | — |
| 6) Feeling of anxiousness (wk 26) | -0.18 | — |
| 6) Feeling of anxiousness (wk 52) | -0.16 | — |
| 6) Feeling of anxiousness (wk 78) | 0.12 | — |
| 7) Feeling of alertness (wk 26) | 0.03 | — |
| 7) Feeling of alertness (wk 52) | -0.14 | — |
| 7) Feeling of alertness (wk 78) | -0.04 | — |
| 8) Feeling of contentment (wk 26) | 0.04 | — |
| 8) Feeling of contentment (wk 52) | 0.08 | — |
| 8) Feeling of contentment (wk 78) | -0.03 | — |
| 9) Food cravings during last 7 days (wk 26) | -0.41 | — |
| 9) Food cravings during last 7 days (wk 52) | -0.30 | — |
| 9) Food cravings during last 7 days (wk 78) | -0.28 | — |
| 10) Strength of food cravings (wk 26) | -0.33 | — |
| 10) Strength of food cravings (wk 52) | -0.14 | — |
| 10) Strength of food cravings (wk 78) | -0.28 | — |
| 11) Difficulty to resist food cravings (wk 26) | -0.38 | — |
| 11) Difficulty to resist food cravings (wk 52) | -0.23 | — |
| 11) Difficulty to resist food cravings (wk 78) | -0.32 | — |
| 12) Eating in response to food cravings (wk 26) | -0.15 | — |
| 12) Eating in response to food cravings (wk 52) | -0.11 | — |
| 12) Eating in response to food cravings (wk 78) | 0.01 | — |
| 13) Cravings for chocolate (wk 26) | -0.03 | — |
| 13) Cravings for chocolate (wk 52) | 0.03 | — |
| 13) Cravings for chocolate (wk 78) | 0.00 | — |
| 14) Cravings for other sweet foods (wk 26) | -0.31 | — |
| 14) Cravings for other sweet foods (wk 52) | -0.34 | — |
| 14) Cravings for other sweet foods (wk 78) | -0.14 | — |
| 15) Cravings for fruit or fruit juice (wk 26) | -0.03 | — |
| 15) Cravings for fruit or fruit juice (wk 52) | -0.01 | — |
| 15) Cravings for fruit or fruit juice (wk 78) | -0.11 | — |
| 16) Cravings for dairy foods (wk 26) | -0.20 | — |
| 16) Cravings for dairy foods (wk 52) | -0.30 | — |
| 16) Cravings for dairy foods (wk 78) | -0.20 | — |
| 17) Cravings for starchy foods (wk 26) | -0.24 | — |
| 17) Cravings for starchy foods (wk 52) | -0.35 | — |
| 17) Cravings for starchy foods (wk 78) | -0.32 | — |
| 18) Cravings for savoury foods (wk 26) | -0.16 | — |
| 18) Cravings for savoury foods (wk 52) | -0.20 | — |
| 18) Cravings for savoury foods (wk 78) | -0.16 | — |
| 19) Difficulty to control eating in general(wk 26) | -0.69 | — |
| 19) Difficulty to control eating in general(wk 52) | -0.59 | — |
| 19) Difficulty to control eating in general(wk 78) | -0.59 | — |
| Craving control: items 9-12, 19 (wk 26) | 0.39 | — |
| Craving control: items 9-12, 19 (wk 52) | 0.27 | — |
| Craving control: items 9-12, 19 (wk 78) | 0.29 | — |
| Positive mood: items 5-8 (wk 26) | 0.07 | — |
| Positive mood: items 5-8 (wk 52) | 0.03 | — |
| Positive mood: items 5-8 (wk 78) | -0.07 | — |
| Craving for savoury: items 4, 16-18 (wk 26) | -0.19 | — |
| Craving for savoury: items 4, 16-18 (wk 52) | -0.27 | — |
| Craving for savoury: items 4, 16-18 (wk 78) | -0.26 | — |
| Craving for sweet: items 3, 13-15 (wk 26) | -0.23 | — |
| Craving for sweet: items 3, 13-15 (wk 52) | -0.15 | — |
| Craving for sweet: items 3, 13-15 (wk 78) | -0.16 | — |
| Oral Semaglutide 14 mg1) Feeling of hunger (wk 26) | -0.54 | — |
| 1) Feeling of hunger (wk 52) | -0.35 | — |
| 1) Feeling of hunger (wk 78) | -0.36 | — |
| 2) Feeling of fullness (wk 26) | 0.15 | — |
| 2) Feeling of fullness (wk 52) | 0.22 | — |
| 2) Feeling of fullness (wk 78) | 0.09 | — |
| 3) Desire to eat sweet foods (wk 26) | -0.47 | — |
| 3) Desire to eat sweet foods (wk 52) | -0.31 | — |
| 3) Desire to eat sweet foods (wk 78) | -0.45 | — |
| 4) Desire to eat savoury foods (wk 26) | -0.30 | — |
| 4) Desire to eat savoury foods (wk 52) | -0.44 | — |
| 4) Desire to eat savoury foods (wk 78) | -0.39 | — |
| 5) Feeling of happiness (wk 26) | 0.04 | — |
| 5) Feeling of happiness (wk 52) | 0.09 | — |
| 5) Feeling of happiness (wk 78) | 0.04 | — |
| 6) Feeling of anxiousness (wk 26) | 0.20 | — |
| 6) Feeling of anxiousness (wk 52) | -0.06 | — |
| 6) Feeling of anxiousness (wk 78) | -0.12 | — |
| 7) Feeling of alertness (wk 26) | -0.06 | — |
| 7) Feeling of alertness (wk 52) | -0.05 | — |
| 7) Feeling of alertness (wk 78) | 0.04 | — |
| 8) Feeling of contentment (wk 26) | 0.18 | — |
| 8) Feeling of contentment (wk 52) | 0.13 | — |
| 8) Feeling of contentment (wk 78) | 0.17 | — |
| 9) Food cravings during last 7 days (wk 26) | -0.37 | — |
| 9) Food cravings during last 7 days (wk 52) | -0.25 | — |
| 9) Food cravings during last 7 days (wk 78) | -0.38 | — |
| 10) Strength of food cravings (wk 26) | -0.25 | — |
| 10) Strength of food cravings (wk 52) | -0.21 | — |
| 10) Strength of food cravings (wk 78) | -0.32 | — |
| 11) Difficulty to resist food cravings (wk 26) | -0.46 | — |
| 11) Difficulty to resist food cravings (wk 52) | -0.42 | — |
| 11) Difficulty to resist food cravings (wk 78) | -0.24 | — |
| 12) Eating in response to food cravings (wk 26) | -0.17 | — |
| 12) Eating in response to food cravings (wk 52) | -0.25 | — |
| 12) Eating in response to food cravings (wk 78) | -0.17 | — |
| 13) Cravings for chocolate (wk 26) | -0.14 | — |
| 13) Cravings for chocolate (wk 52) | 0.06 | — |
| 13) Cravings for chocolate (wk 78) | 0.06 | — |
| 14) Cravings for other sweet foods (wk 26) | -0.36 | — |
| 14) Cravings for other sweet foods (wk 52) | -0.31 | — |
| 14) Cravings for other sweet foods (wk 78) | -0.40 | — |
| 15) Cravings for fruit or fruit juice (wk 26) | -0.09 | — |
| 15) Cravings for fruit or fruit juice (wk 52) | -0.22 | — |
| 15) Cravings for fruit or fruit juice (wk 78) | -0.02 | — |
| 16) Cravings for dairy foods (wk 26) | -0.37 | — |
| 16) Cravings for dairy foods (wk 52) | -0.41 | — |
| 16) Cravings for dairy foods (wk 78) | -0.45 | — |
| 17) Cravings for starchy foods (wk 26) | -0.49 | — |
| 17) Cravings for starchy foods (wk 52) | -0.62 | — |
| 17) Cravings for starchy foods (wk 78) | -0.61 | — |
| 18) Cravings for savoury foods (wk 26) | -0.49 | — |
| 18) Cravings for savoury foods (wk 52) | -0.56 | — |
| 18) Cravings for savoury foods (wk 78) | -0.48 | — |
| 19) Difficulty to control eating in general(wk 26) | -0.49 | — |
| 19) Difficulty to control eating in general(wk 52) | -0.56 | — |
| 19) Difficulty to control eating in general(wk 78) | -0.54 | — |
| Craving control: items 9-12, 19 (wk 26) | 0.35 | — |
| Craving control: items 9-12, 19 (wk 52) | 0.34 | — |
| Craving control: items 9-12, 19 (wk 78) | 0.33 | — |
| Positive mood: items 5-8 (wk 26) | -0.01 | — |
| Positive mood: items 5-8 (wk 52) | 0.05 | — |
| Positive mood: items 5-8 (wk 78) | 0.09 | — |
| Craving for savoury: items 4, 16-18 (wk 26) | -0.41 | — |
| Craving for savoury: items 4, 16-18 (wk 52) | -0.51 | — |
| Craving for savoury: items 4, 16-18 (wk 78) | -0.48 | — |
| Craving for sweet: items 3, 13-15 (wk 26) | -0.26 | — |
| Craving for sweet: items 3, 13-15 (wk 52) | -0.19 | — |
| Craving for sweet: items 3, 13-15 (wk 78) | -0.20 | — |
| Sitagliptin 100 mg1) Feeling of hunger (wk 26) | -0.18 | — |
| 1) Feeling of hunger (wk 52) | -0.25 | — |
| 1) Feeling of hunger (wk 78) | -0.22 | — |
| 2) Feeling of fullness (wk 26) | 0.15 | — |
| 2) Feeling of fullness (wk 52) | 0.27 | — |
| 2) Feeling of fullness (wk 78) | 0.26 | — |
| 3) Desire to eat sweet foods (wk 26) | -0.33 | — |
| 3) Desire to eat sweet foods (wk 52) | -0.45 | — |
| 3) Desire to eat sweet foods (wk 78) | -0.49 | — |
| 4) Desire to eat savoury foods (wk 26) | -0.35 | — |
| 4) Desire to eat savoury foods (wk 52) | -0.33 | — |
| 4) Desire to eat savoury foods (wk 78) | -0.42 | — |
| 5) Feeling of happiness (wk 26) | 0.13 | — |
| 5) Feeling of happiness (wk 52) | 0.14 | — |
| 5) Feeling of happiness (wk 78) | 0.02 | — |
| 6) Feeling of anxiousness (wk 26) | -0.21 | — |
| 6) Feeling of anxiousness (wk 52) | 0.17 | — |
| 6) Feeling of anxiousness (wk 78) | -0.01 | — |
| 7) Feeling of alertness (wk 26) | 0.05 | — |
| 7) Feeling of alertness (wk 52) | -0.05 | — |
| 7) Feeling of alertness (wk 78) | -0.01 | — |
| 8) Feeling of contentment (wk 26) | 0.18 | — |
| 8) Feeling of contentment (wk 52) | 0.20 | — |
| 8) Feeling of contentment (wk 78) | 0.17 | — |
| 9) Food cravings during last 7 days (wk 26) | -0.46 | — |
| 9) Food cravings during last 7 days (wk 52) | -0.21 | — |
| 9) Food cravings during last 7 days (wk 78) | -0.33 | — |
| 10) Strength of food cravings (wk 26) | -0.35 | — |
| 10) Strength of food cravings (wk 52) | -0.30 | — |
| 10) Strength of food cravings (wk 78) | -0.38 | — |
| 11) Difficulty to resist food cravings (wk 26) | -0.17 | — |
| 11) Difficulty to resist food cravings (wk 52) | -0.26 | — |
| 11) Difficulty to resist food cravings (wk 78) | -0.22 | — |
| 12) Eating in response to food cravings (wk 26) | -0.27 | — |
| 12) Eating in response to food cravings (wk 52) | -0.17 | — |
| 12) Eating in response to food cravings (wk 78) | -0.25 | — |
| 13) Cravings for chocolate (wk 26) | -0.15 | — |
| 13) Cravings for chocolate (wk 52) | 0.03 | — |
| 13) Cravings for chocolate (wk 78) | 0.06 | — |
| 14) Cravings for other sweet foods (wk 26) | -0.33 | — |
| 14) Cravings for other sweet foods (wk 52) | -0.09 | — |
| 14) Cravings for other sweet foods (wk 78) | -0.22 | — |
| 15) Cravings for fruit or fruit juice (wk 26) | -0.07 | — |
| 15) Cravings for fruit or fruit juice (wk 52) | -0.08 | — |
| 15) Cravings for fruit or fruit juice (wk 78) | -0.33 | — |
| 16) Cravings for dairy foods (wk 26) | -0.27 | — |
| 16) Cravings for dairy foods (wk 52) | 0.04 | — |
| 16) Cravings for dairy foods (wk 78) | -0.20 | — |
| 17) Cravings for starchy foods (wk 26) | -0.42 | — |
| 17) Cravings for starchy foods (wk 52) | -0.28 | — |
| 17) Cravings for starchy foods (wk 78) | -0.36 | — |
| 18) Cravings for savoury foods (wk 26) | -0.40 | — |
| 18) Cravings for savoury foods (wk 52) | -0.37 | — |
| 18) Cravings for savoury foods (wk 78) | -0.34 | — |
| 19) Difficulty to control eating in general(wk 26) | -0.51 | — |
| 19) Difficulty to control eating in general(wk 52) | -0.51 | — |
| 19) Difficulty to control eating in general(wk 78) | -0.51 | — |
| Craving control: items 9-12, 19 (wk 26) | 0.35 | — |
| Craving control: items 9-12, 19 (wk 52) | 0.29 | — |
| Craving control: items 9-12, 19 (wk 78) | 0.34 | — |
| Positive mood: items 5-8 (wk 26) | 0.15 | — |
| Positive mood: items 5-8 (wk 52) | 0.03 | — |
| Positive mood: items 5-8 (wk 78) | 0.05 | — |
| Craving for savoury: items 4, 16-18 (wk 26) | -0.36 | — |
| Craving for savoury: items 4, 16-18 (wk 52) | -0.24 | — |
| Craving for savoury: items 4, 16-18 (wk 78) | -0.33 | — |
| Craving for sweet: items 3, 13-15 (wk 26) | -0.22 | — |
| Craving for sweet: items 3, 13-15 (wk 52) | -0.15 | — |
| Craving for sweet: items 3, 13-15 (wk 78) | -0.24 | — |
Secondary/protocol endpoint
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)
Time frame:Week 0, week 26, week 52, week 78
SF-36 total
change from baseline, improvement
Secondary/protocol endpoint
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains
Time frame:Week 0, week 26, week 52, week 78
IWQOL-Lite total
change from baseline, improvement
Secondary/protocol endpoint
Change in CoEQ: Scores From the 4 Domains and the 19 Items
Time frame:Week 0, week 26, week 52, week 78
change from baseline, improvement
Safety / tolerability / PK
26 endpointsSecondary/registry result
Number of TEAEs During Exposure to Trial Product
Time frame:Weeks 0-83
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), Events | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | 1774 | — |
| Oral Semaglutide 7 mg | 1686 | — |
| Oral Semaglutide 14 mg | 1824 | — |
| Sitagliptin 100 mg | 1852 | — |
Secondary/registry result
Change in Amylase (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.03 | — |
| Week 52 | 1.03 | — |
| Week 78 | 1.02 | — |
| Oral Semaglutide 7 mgWeek 26 | 1.07 | — |
| Week 52 | 1.09 | — |
| Week 78 | 1.09 | — |
| Oral Semaglutide 14 mgWeek 26 | 1.14 | — |
| Week 52 | 1.11 | — |
| Week 78 | 1.09 | — |
| Sitagliptin 100 mgWeek 26 | 1.08 | — |
| Week 52 | 1.08 | — |
| Week 78 | 1.08 | — |
Secondary/registry result
Change in Lipase (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.07 | — |
| Week 52 | 1.06 | — |
| Week 78 | 1.04 | — |
| Oral Semaglutide 7 mgWeek 26 | 1.13 | — |
| Week 52 | 1.15 | — |
| Week 78 | 1.14 | — |
| Oral Semaglutide 14 mgWeek 26 | 1.26 | — |
| Week 52 | 1.25 | — |
| Week 78 | 1.18 | — |
| Sitagliptin 100 mgWeek 26 | 1.14 | — |
| Week 52 | 1.15 | — |
| Week 78 | 1.10 | — |
Secondary/registry result
Change in ECG Evaluation
Time frame:Week 0, week 26, week 52, week 78
categorical status, descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgNormal (week 0) to normal (week 26) | 211 | — |
| Normal (week 0) to abnormal NCS (week 26) | 38 | — |
| Normal (week 0) to abnormal CS (week 26) | 4 | — |
| Abnormal (week 0) NCS to normal (week 26) | 41 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 26) | 132 | — |
| Abnormal (week 0) NCS to abnormal CS (week 26) | 4 | — |
| Abnormal (week 0) CS to normal (week 26) | 1 | — |
| Abnormal (week 0) CS to abnormal NCS (week 26) | 3 | — |
| Abnormal (week 0) CS to abnormal CS (week 26) | 4 | — |
| Normal (week 0) to normal (week 52) | 196 | — |
| Normal (week 0) to abnormal NCS (week 52) | 47 | — |
| Normal (week 0) to abnormal CS (week 52) | 1 | — |
| Abnormal (week 0) NCS to normal (week 52) | 40 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 52) | 131 | — |
| Abnormal (week 0) NCS to abnormal CS (week 52) | 4 | — |
| Abnormal (week 0) CS to normal (week 52) | 1 | — |
| Abnormal (week 0) CS to abnormal NCS (week 52) | 3 | — |
| Abnormal (week 0) CS to abnormal CS (week 52) | 4 | — |
| Normal (week 0) to normal (week 78) | 196 | — |
| Normal (week 0) to abnormal NCS (week 78) | 41 | — |
| Normal (week 0) to abnormal CS (week 78) | 3 | — |
| Abnormal (week 0) NCS to normal (week 78) | 39 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 78) | 131 | — |
| Abnormal (week 0) NCS to abnormal CS (week 78) | 5 | — |
| Abnormal (week 0) CS to normal (week 78) | 0 | — |
| Abnormal (week 0) CS to abnormal NCS (week 78) | 4 | — |
| Abnormal (week 0) CS to abnormal CS (week 78) | 4 | — |
| Oral Semaglutide 7 mgNormal (week 0) to normal (week 26) | 214 | — |
| Normal (week 0) to abnormal NCS (week 26) | 42 | — |
| Normal (week 0) to abnormal CS (week 26) | 5 | — |
| Abnormal (week 0) NCS to normal (week 26) | 44 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 26) | 128 | — |
| Abnormal (week 0) NCS to abnormal CS (week 26) | 1 | — |
| Abnormal (week 0) CS to normal (week 26) | 1 | — |
| Abnormal (week 0) CS to abnormal NCS (week 26) | 2 | — |
| Abnormal (week 0) CS to abnormal CS (week 26) | 2 | — |
| Normal (week 0) to normal (week 52) | 218 | — |
| Normal (week 0) to abnormal NCS (week 52) | 37 | — |
| Normal (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal (week 0) NCS to normal (week 52) | 49 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 52) | 123 | — |
| Abnormal (week 0) NCS to abnormal CS (week 52) | 1 | — |
| Abnormal (week 0) CS to normal (week 52) | 1 | — |
| Abnormal (week 0) CS to abnormal NCS (week 52) | 3 | — |
| Abnormal (week 0) CS to abnormal CS (week 52) | 1 | — |
| Normal (week 0) to normal (week 78) | 201 | — |
| Normal (week 0) to abnormal NCS (week 78) | 43 | — |
| Normal (week 0) to abnormal CS (week 78) | 2 | — |
| Abnormal (week 0) NCS to normal (week 78) | 45 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 78) | 125 | — |
| Abnormal (week 0) NCS to abnormal CS (week 78) | 1 | — |
| Abnormal (week 0) CS to normal (week 78) | 3 | — |
| Abnormal (week 0) CS to abnormal NCS (week 78) | 2 | — |
| Abnormal (week 0) CS to abnormal CS (week 78) | 1 | — |
| Oral Semaglutide 14 mgNormal (week 0) to normal (week 26) | 230 | — |
| Normal (week 0) to abnormal NCS (week 26) | 24 | — |
| Normal (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal (week 0) NCS to normal (week 26) | 42 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 26) | 133 | — |
| Abnormal (week 0) NCS to abnormal CS (week 26) | 1 | — |
| Abnormal (week 0) CS to normal (week 26) | 0 | — |
| Abnormal (week 0) CS to abnormal NCS (week 26) | 3 | — |
| Abnormal (week 0) CS to abnormal CS (week 26) | 6 | — |
| Normal (week 0) to normal (week 52) | 219 | — |
| Normal (week 0) to abnormal NCS (week 52) | 33 | — |
| Normal (week 0) to abnormal CS (week 52) | 1 | — |
| Abnormal (week 0) NCS to normal (week 52) | 56 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 52) | 118 | — |
| Abnormal (week 0) NCS to abnormal CS (week 52) | 0 | — |
| Abnormal (week 0) CS to normal (week 52) | 2 | — |
| Abnormal (week 0) CS to abnormal NCS (week 52) | 0 | — |
| Abnormal (week 0) CS to abnormal CS (week 52) | 7 | — |
| Normal (week 0) to normal (week 78) | 219 | — |
| Normal (week 0) to abnormal NCS (week 78) | 31 | — |
| Normal (week 0) to abnormal CS (week 78) | 1 | — |
| Abnormal (week 0) NCS to normal (week 78) | 51 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 78) | 114 | — |
| Abnormal (week 0) NCS to abnormal CS (week 78) | 3 | — |
| Abnormal (week 0) CS to normal (week 78) | 1 | — |
| Abnormal (week 0) CS to abnormal NCS (week 78) | 3 | — |
| Abnormal (week 0) CS to abnormal CS (week 78) | 5 | — |
| Sitagliptin 100 mgNormal (week 0) to normal (week 26) | 204 | — |
| Normal (week 0) to abnormal NCS (week 26) | 41 | — |
| Normal (week 0) to abnormal CS (week 26) | 4 | — |
| Abnormal (week 0) NCS to normal (week 26) | 40 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 26) | 143 | — |
| Abnormal (week 0) NCS to abnormal CS (week 26) | 3 | — |
| Abnormal (week 0) CS to normal (week 26) | 3 | — |
| Abnormal (week 0) CS to abnormal NCS (week 26) | 2 | — |
| Abnormal (week 0) CS to abnormal CS (week 26) | 4 | — |
| Normal (week 0) to normal (week 52) | 204 | — |
| Normal (week 0) to abnormal NCS (week 52) | 40 | — |
| Normal (week 0) to abnormal CS (week 52) | 4 | — |
| Abnormal (week 0) NCS to normal (week 52) | 48 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 52) | 128 | — |
| Abnormal (week 0) NCS to abnormal CS (week 52) | 2 | — |
| Abnormal (week 0) CS to normal (week 52) | 1 | — |
| Abnormal (week 0) CS to abnormal NCS (week 52) | 2 | — |
| Abnormal (week 0) CS to abnormal CS (week 52) | 6 | — |
| Normal (week 0) to normal (week 78) | 208 | — |
| Normal (week 0) to abnormal NCS (week 78) | 40 | — |
| Normal (week 0) to abnormal CS (week 78) | 1 | — |
| Abnormal (week 0) NCS to normal (week 78) | 47 | — |
| Abnormal (week 0) NCS to abnormal NCS (week 78) | 133 | — |
| Abnormal (week 0) NCS to abnormal CS (week 78) | 2 | — |
| Abnormal (week 0) CS to normal (week 78) | 3 | — |
| Abnormal (week 0) CS to abnormal NCS (week 78) | 2 | — |
| Abnormal (week 0) CS to abnormal CS (week 78) | 4 | — |
Secondary/registry result
Change in Physical Examination
Time frame:Week -2, week 52, week 78
descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg1) Cardiovascular system (week -2) | 431 | — |
| 1) Cardiovascular system (week -2) | 30 | — |
| 1) Cardiovascular system (week -2) | 5 | — |
| 1) Cardiovascular system (week 52) | 398 | — |
| 1) Cardiovascular system (week 52) | 24 | — |
| 1) Cardiovascular system (week 52) | 5 | — |
| 1) Cardiovascular system (week 78) | 395 | — |
| 1) Cardiovascular system (week 78) | 24 | — |
| 1) Cardiovascular system (week 78) | 5 | — |
| 2) Central and peripheral nervous system (week -2) | 410 | — |
| 2) Central and peripheral nervous system (week -2) | 44 | — |
| 2) Central and peripheral nervous system (week -2) | 12 | — |
| 2) Central and peripheral nervous system (week 52) | 376 | — |
| 2) Central and peripheral nervous system (week 52) | 44 | — |
| 2) Central and peripheral nervous system (week 52) | 7 | — |
| 2) Central and peripheral nervous system (week 78) | 377 | — |
| 2) Central and peripheral nervous system (week 78) | 43 | — |
| 2) Central and peripheral nervous system (week 78) | 4 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 419 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 45 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 2 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 386 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 39 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 1 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 398 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 26 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 0 | — |
| 4) General appearance (week -2) | 407 | — |
| 4) General appearance (week -2) | 43 | — |
| 4) General appearance (week -2) | 16 | — |
| 4) General appearance (week 52) | 381 | — |
| 4) General appearance (week 52) | 37 | — |
| 4) General appearance (week 52) | 8 | — |
| 4) General appearance (week 78) | 379 | — |
| 4) General appearance (week 78) | 37 | — |
| 4) General appearance (week 78) | 8 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 441 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 25 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 0 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 398 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 25 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 3 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 400 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 22 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 2 | — |
| 6) Lymph node palpation (week -2) | 466 | — |
| 6) Lymph node palpation (week -2) | 0 | — |
| 6) Lymph node palpation (week -2) | 0 | — |
| 6) Lymph node palpation (week 52) | 425 | — |
| 6) Lymph node palpation (week 52) | 1 | — |
| 6) Lymph node palpation (week 52) | 0 | — |
| 6) Lymph node palpation (week 78) | 421 | — |
| 6) Lymph node palpation (week 78) | 2 | — |
| 6) Lymph node palpation (week 78) | 0 | — |
| 7) Musculoskeletal system (week -2) | 421 | — |
| 7) Musculoskeletal system (week -2) | 39 | — |
| 7) Musculoskeletal system (week -2) | 6 | — |
| 7) Musculoskeletal system (week 52) | 383 | — |
| 7) Musculoskeletal system (week 52) | 37 | — |
| 7) Musculoskeletal system (week 52) | 6 | — |
| 7) Musculoskeletal system (week 78) | 388 | — |
| 7) Musculoskeletal system (week 78) | 33 | — |
| 7) Musculoskeletal system (week 78) | 3 | — |
| 8) Respiratory system (week -2) | 458 | — |
| 8) Respiratory system (week -2) | 6 | — |
| 8) Respiratory system (week -2) | 2 | — |
| 8) Respiratory system (week 52) | 418 | — |
| 8) Respiratory system (week 52) | 6 | — |
| 8) Respiratory system (week 52) | 2 | — |
| 8) Respiratory system (week 78) | 419 | — |
| 8) Respiratory system (week 78) | 3 | — |
| 8) Respiratory system (week 78) | 2 | — |
| 9) Skin (week -2) | 394 | — |
| 9) Skin (week -2) | 66 | — |
| 9) Skin (week -2) | 6 | — |
| 9) Skin (week 52) | 372 | — |
| 9) Skin (week 52) | 52 | — |
| 9) Skin (week 52) | 3 | — |
| 9) Skin (week 78) | 361 | — |
| 9) Skin (week 78) | 55 | — |
| 9) Skin (week 78) | 8 | — |
| 10) Thyroid gland (week -2) | 451 | — |
| 10) Thyroid gland (week -2) | 13 | — |
| 10) Thyroid gland (week -2) | 1 | — |
| 10) Thyroid gland (week 52) | 413 | — |
| 10) Thyroid gland (week 52) | 11 | — |
| 10) Thyroid gland (week 52) | 2 | — |
| 10) Thyroid gland (week 78) | 411 | — |
| 10) Thyroid gland (week 78) | 11 | — |
| 10) Thyroid gland (week 78) | 2 | — |
| Oral Semaglutide 7 mg1) Cardiovascular system (week -2) | 425 | — |
| 1) Cardiovascular system (week -2) | 38 | — |
| 1) Cardiovascular system (week -2) | 1 | — |
| 1) Cardiovascular system (week 52) | 396 | — |
| 1) Cardiovascular system (week 52) | 36 | — |
| 1) Cardiovascular system (week 52) | 1 | — |
| 1) Cardiovascular system (week 78) | 386 | — |
| 1) Cardiovascular system (week 78) | 33 | — |
| 1) Cardiovascular system (week 78) | 4 | — |
| 2) Central and peripheral nervous system (week -2) | 415 | — |
| 2) Central and peripheral nervous system (week -2) | 42 | — |
| 2) Central and peripheral nervous system (week -2) | 6 | — |
| 2) Central and peripheral nervous system (week 52) | 382 | — |
| 2) Central and peripheral nervous system (week 52) | 45 | — |
| 2) Central and peripheral nervous system (week 52) | 6 | — |
| 2) Central and peripheral nervous system (week 78) | 376 | — |
| 2) Central and peripheral nervous system (week 78) | 43 | — |
| 2) Central and peripheral nervous system (week 78) | 4 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 421 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 39 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 4 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 402 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 28 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 3 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 387 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 31 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 5 | — |
| 4) General appearance (week -2) | 405 | — |
| 4) General appearance (week -2) | 45 | — |
| 4) General appearance (week -2) | 14 | — |
| 4) General appearance (week 52) | 384 | — |
| 4) General appearance (week 52) | 37 | — |
| 4) General appearance (week 52) | 12 | — |
| 4) General appearance (week 78) | 373 | — |
| 4) General appearance (week 78) | 40 | — |
| 4) General appearance (week 78) | 10 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 440 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 24 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 0 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 411 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 21 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 1 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 405 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 17 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 1 | — |
| 6) Lymph node palpation (week -2) | 462 | — |
| 6) Lymph node palpation (week -2) | 1 | — |
| 6) Lymph node palpation (week -2) | 0 | — |
| 6) Lymph node palpation (week 52) | 432 | — |
| 6) Lymph node palpation (week 52) | 1 | — |
| 6) Lymph node palpation (week 52) | 0 | — |
| 6) Lymph node palpation (week 78) | 423 | — |
| 6) Lymph node palpation (week 78) | 0 | — |
| 6) Lymph node palpation (week 78) | 0 | — |
| 7) Musculoskeletal system (week -2) | 435 | — |
| 7) Musculoskeletal system (week -2) | 24 | — |
| 7) Musculoskeletal system (week -2) | 5 | — |
| 7) Musculoskeletal system (week 52) | 400 | — |
| 7) Musculoskeletal system (week 52) | 28 | — |
| 7) Musculoskeletal system (week 52) | 5 | — |
| 7) Musculoskeletal system (week 78) | 389 | — |
| 7) Musculoskeletal system (week 78) | 31 | — |
| 7) Musculoskeletal system (week 78) | 3 | — |
| 8) Respiratory system (week -2) | 451 | — |
| 8) Respiratory system (week -2) | 9 | — |
| 8) Respiratory system (week -2) | 4 | — |
| 8) Respiratory system (week 52) | 427 | — |
| 8) Respiratory system (week 52) | 4 | — |
| 8) Respiratory system (week 52) | 2 | — |
| 8) Respiratory system (week 78) | 418 | — |
| 8) Respiratory system (week 78) | 4 | — |
| 8) Respiratory system (week 78) | 1 | — |
| 9) Skin (week -2) | 400 | — |
| 9) Skin (week -2) | 56 | — |
| 9) Skin (week -2) | 8 | — |
| 9) Skin (week 52) | 383 | — |
| 9) Skin (week 52) | 44 | — |
| 9) Skin (week 52) | 6 | — |
| 9) Skin (week 78) | 370 | — |
| 9) Skin (week 78) | 45 | — |
| 9) Skin (week 78) | 8 | — |
| 10) Thyroid gland (week -2) | 452 | — |
| 10) Thyroid gland (week -2) | 11 | — |
| 10) Thyroid gland (week -2) | 1 | — |
| 10) Thyroid gland (week 52) | 423 | — |
| 10) Thyroid gland (week 52) | 10 | — |
| 10) Thyroid gland (week 52) | 0 | — |
| 10) Thyroid gland (week 78) | 411 | — |
| 10) Thyroid gland (week 78) | 12 | — |
| 10) Thyroid gland (week 78) | 0 | — |
| Oral Semaglutide 14 mg1) Cardiovascular system (week -2) | 432 | — |
| 1) Cardiovascular system (week -2) | 30 | — |
| 1) Cardiovascular system (week -2) | 3 | — |
| 1) Cardiovascular system (week 52) | 404 | — |
| 1) Cardiovascular system (week 52) | 28 | — |
| 1) Cardiovascular system (week 52) | 3 | — |
| 1) Cardiovascular system (week 78) | 402 | — |
| 1) Cardiovascular system (week 78) | 24 | — |
| 1) Cardiovascular system (week 78) | 2 | — |
| 2) Central and peripheral nervous system (week -2) | 407 | — |
| 2) Central and peripheral nervous system (week -2) | 49 | — |
| 2) Central and peripheral nervous system (week -2) | 8 | — |
| 2) Central and peripheral nervous system (week 52) | 388 | — |
| 2) Central and peripheral nervous system (week 52) | 38 | — |
| 2) Central and peripheral nervous system (week 52) | 9 | — |
| 2) Central and peripheral nervous system (week 78) | 384 | — |
| 2) Central and peripheral nervous system (week 78) | 37 | — |
| 2) Central and peripheral nervous system (week 78) | 7 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 420 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 45 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 0 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 397 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 36 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 2 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 393 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 35 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 0 | — |
| 4) General appearance (week -2) | 412 | — |
| 4) General appearance (week -2) | 38 | — |
| 4) General appearance (week -2) | 15 | — |
| 4) General appearance (week 52) | 390 | — |
| 4) General appearance (week 52) | 33 | — |
| 4) General appearance (week 52) | 12 | — |
| 4) General appearance (week 78) | 388 | — |
| 4) General appearance (week 78) | 28 | — |
| 4) General appearance (week 78) | 12 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 435 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 27 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 3 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 404 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 27 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 4 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 399 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 28 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 1 | — |
| 6) Lymph node palpation (week -2) | 463 | — |
| 6) Lymph node palpation (week -2) | 2 | — |
| 6) Lymph node palpation (week -2) | 0 | — |
| 6) Lymph node palpation (week 52) | 434 | — |
| 6) Lymph node palpation (week 52) | 1 | — |
| 6) Lymph node palpation (week 52) | 0 | — |
| 6) Lymph node palpation (week 78) | 425 | — |
| 6) Lymph node palpation (week 78) | 3 | — |
| 6) Lymph node palpation (week 78) | 0 | — |
| 7) Musculoskeletal system (week -2) | 440 | — |
| 7) Musculoskeletal system (week -2) | 23 | — |
| 7) Musculoskeletal system (week -2) | 2 | — |
| 7) Musculoskeletal system (week 52) | 408 | — |
| 7) Musculoskeletal system (week 52) | 24 | — |
| 7) Musculoskeletal system (week 52) | 3 | — |
| 7) Musculoskeletal system (week 78) | 402 | — |
| 7) Musculoskeletal system (week 78) | 24 | — |
| 7) Musculoskeletal system (week 78) | 2 | — |
| 8) Respiratory system (week -2) | 462 | — |
| 8) Respiratory system (week -2) | 2 | — |
| 8) Respiratory system (week -2) | 1 | — |
| 8) Respiratory system (week 52) | 431 | — |
| 8) Respiratory system (week 52) | 3 | — |
| 8) Respiratory system (week 52) | 1 | — |
| 8) Respiratory system (week 78) | 427 | — |
| 8) Respiratory system (week 78) | 1 | — |
| 8) Respiratory system (week 78) | 0 | — |
| 9) Skin (week -2) | 394 | — |
| 9) Skin (week -2) | 61 | — |
| 9) Skin (week -2) | 10 | — |
| 9) Skin (week 52) | 383 | — |
| 9) Skin (week 52) | 44 | — |
| 9) Skin (week 52) | 8 | — |
| 9) Skin (week 78) | 382 | — |
| 9) Skin (week 78) | 38 | — |
| 9) Skin (week 78) | 8 | — |
| 10) Thyroid gland (week -2) | 451 | — |
| 10) Thyroid gland (week -2) | 11 | — |
| 10) Thyroid gland (week -2) | 3 | — |
| 10) Thyroid gland (week 52) | 425 | — |
| 10) Thyroid gland (week 52) | 7 | — |
| 10) Thyroid gland (week 52) | 3 | — |
| 10) Thyroid gland (week 78) | 418 | — |
| 10) Thyroid gland (week 78) | 8 | — |
| 10) Thyroid gland (week 78) | 2 | — |
| Sitagliptin 100 mg1) Cardiovascular system (week -2) | 424 | — |
| 1) Cardiovascular system (week -2) | 41 | — |
| 1) Cardiovascular system (week -2) | 1 | — |
| 1) Cardiovascular system (week 52) | 399 | — |
| 1) Cardiovascular system (week 52) | 37 | — |
| 1) Cardiovascular system (week 52) | 0 | — |
| 1) Cardiovascular system (week 78) | 399 | — |
| 1) Cardiovascular system (week 78) | 41 | — |
| 1) Cardiovascular system (week 78) | 1 | — |
| 2) Central and peripheral nervous system (week -2) | 409 | — |
| 2) Central and peripheral nervous system (week -2) | 43 | — |
| 2) Central and peripheral nervous system (week -2) | 14 | — |
| 2) Central and peripheral nervous system (week 52) | 385 | — |
| 2) Central and peripheral nervous system (week 52) | 42 | — |
| 2) Central and peripheral nervous system (week 52) | 8 | — |
| 2) Central and peripheral nervous system (week 78) | 399 | — |
| 2) Central and peripheral nervous system (week 78) | 37 | — |
| 2) Central and peripheral nervous system (week 78) | 5 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 421 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 45 | — |
| 3) Gastrointestinal system, incl. mouth (week -2) | 0 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 394 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 40 | — |
| 3) Gastrointestinal system, incl. mouth (week 52) | 2 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 408 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 31 | — |
| 3) Gastrointestinal system, incl. mouth (week 78) | 2 | — |
| 4) General appearance (week -2) | 405 | — |
| 4) General appearance (week -2) | 46 | — |
| 4) General appearance (week -2) | 15 | — |
| 4) General appearance (week 52) | 385 | — |
| 4) General appearance (week 52) | 39 | — |
| 4) General appearance (week 52) | 12 | — |
| 4) General appearance (week 78) | 394 | — |
| 4) General appearance (week 78) | 37 | — |
| 4) General appearance (week 78) | 10 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 444 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 21 | — |
| 5) Head, ears, eyes, nose, throat, neck (week -2) | 1 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 410 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 26 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 52) | 0 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 415 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 25 | — |
| 5) Head, ears, eyes, nose, throat, neck (week 78) | 1 | — |
| 6) Lymph node palpation (week -2) | 464 | — |
| 6) Lymph node palpation (week -2) | 2 | — |
| 6) Lymph node palpation (week -2) | 0 | — |
| 6) Lymph node palpation (week 52) | 436 | — |
| 6) Lymph node palpation (week 52) | 0 | — |
| 6) Lymph node palpation (week 52) | 0 | — |
| 6) Lymph node palpation (week 78) | 441 | — |
| 6) Lymph node palpation (week 78) | 0 | — |
| 6) Lymph node palpation (week 78) | 0 | — |
| 7) Musculoskeletal system (week -2) | 430 | — |
| 7) Musculoskeletal system (week -2) | 32 | — |
| 7) Musculoskeletal system (week -2) | 4 | — |
| 7) Musculoskeletal system (week 52) | 403 | — |
| 7) Musculoskeletal system (week 52) | 26 | — |
| 7) Musculoskeletal system (week 52) | 6 | — |
| 7) Musculoskeletal system (week 78) | 413 | — |
| 7) Musculoskeletal system (week 78) | 23 | — |
| 7) Musculoskeletal system (week 78) | 5 | — |
| 8) Respiratory system (week -2) | 456 | — |
| 8) Respiratory system (week -2) | 10 | — |
| 8) Respiratory system (week -2) | 0 | — |
| 8) Respiratory system (week 52) | 429 | — |
| 8) Respiratory system (week 52) | 6 | — |
| 8) Respiratory system (week 52) | 1 | — |
| 8) Respiratory system (week 78) | 434 | — |
| 8) Respiratory system (week 78) | 6 | — |
| 8) Respiratory system (week 78) | 1 | — |
| 9) Skin (week -2) | 402 | — |
| 9) Skin (week -2) | 58 | — |
| 9) Skin (week -2) | 6 | — |
| 9) Skin (week 52) | 375 | — |
| 9) Skin (week 52) | 51 | — |
| 9) Skin (week 52) | 10 | — |
| 9) Skin (week 78) | 393 | — |
| 9) Skin (week 78) | 41 | — |
| 9) Skin (week 78) | 7 | — |
| 10) Thyroid gland (week -2) | 454 | — |
| 10) Thyroid gland (week -2) | 12 | — |
| 10) Thyroid gland (week -2) | 0 | — |
| 10) Thyroid gland (week 52) | 427 | — |
| 10) Thyroid gland (week 52) | 8 | — |
| 10) Thyroid gland (week 52) | 1 | — |
| 10) Thyroid gland (week 78) | 433 | — |
| 10) Thyroid gland (week 78) | 7 | — |
| 10) Thyroid gland (week 78) | 1 | — |
Secondary/registry result
Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)
Time frame:Weeks 0-83
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | 1 | — |
| Oral Semaglutide 7 mg | 2 | — |
| Oral Semaglutide 14 mg | 3 | — |
Secondary/registry result
Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)
Time frame:Weeks 0-83
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | 0 | — |
| Oral Semaglutide 7 mg | 0 | — |
| Oral Semaglutide 14 mg | 0 | — |
Secondary/registry result
Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Time frame:Weeks 0-83
Immunogenicity (ADA)
categorical status, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | 0 | — |
| Oral Semaglutide 7 mg | 1 | — |
| Oral Semaglutide 14 mg | 1 | — |
Secondary/registry result
Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Time frame:Weeks 0-83
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | 0 | — |
| Oral Semaglutide 7 mg | 0 | — |
| Oral Semaglutide 14 mg | 0 | — |
Secondary/registry result
Anti-semaglutide Binding Antibody Levels
Time frame:Weeks 0-83
Immunogenicity (ADA)
descriptive
Posted result
| Group | Value (mean), %B/T | 95% CI |
|---|---|---|
| Oral Semaglutide 14 mgWeek 4 | 9.82 | — |
| Week 26 | 2.05 | — |
| Week 38 | 2.24 | — |
| Oral Semaglutide 3 mgWeek 8 | 1.93 | — |
| Oral Semaglutide 7 mgWeek 14 | 3.28 | — |
| Week 26 | 2.39 | — |
Secondary/registry result
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Time frame:Weeks 0-83
Documented hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Posted result
| Group | Value (number), Episodes | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | 56 | — |
| Oral Semaglutide 7 mg | 42 | — |
| Oral Semaglutide 14 mg | 60 | — |
| Sitagliptin 100 mg | 76 | — |
Secondary/registry result
Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Time frame:Weeks 0-83
Severe hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | 23 | — |
| Oral Semaglutide 7 mg | 24 | — |
| Oral Semaglutide 14 mg | 36 | — |
| Sitagliptin 100 mg | 39 | — |
Secondary/registry result
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses
Time frame:Weeks 0-83
Plasma concentration (steady state)
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nmol/L | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 0 | 0.4 | — |
| Week 4 | 1.5 | — |
| Week 8 | 1.5 | — |
| Week 14 | 1.4 | — |
| Week 26 | 1.3 | — |
| Week 38 | 1.4 | — |
| Week 52 | 1.4 | — |
| Week 78 | 1.3 | — |
| Week 83 | 0.4 | — |
| Oral Semaglutide 7 mgWeek 0 | 0.4 | — |
| Week 4 | 1.5 | — |
| Week 8 | 4.1 | — |
| Week 14 | 4.0 | — |
| Week 26 | 3.7 | — |
| Week 38 | 3.5 | — |
| Week 52 | 3.5 | — |
| Week 78 | 3.5 | — |
| Week 83 | 0.4 | — |
| Oral Semaglutide 14 mgWeek 0 | 0.4 | — |
| Week 4 | 1.6 | — |
| Week 8 | 4.2 | — |
| Week 14 | 9.4 | — |
| Week 26 | 8.6 | — |
| Week 38 | 8.6 | — |
| Week 52 | 8.2 | — |
| Week 78 | 8.9 | — |
| Week 83 | 0.4 | — |
Secondary/protocol endpoint
Number of TEAEs During Exposure to Trial Product
Time frame:Weeks 0-83
Treatment-emergent AEs (any)
event count, event
Secondary/protocol endpoint
Change in Amylase (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
ratio, descriptive
Secondary/protocol endpoint
Change in Lipase (Ratio to Baseline)
Time frame:Week 0, week 26, week 52, week 78
ratio, descriptive
Secondary/protocol endpoint
Change in ECG Evaluation
Time frame:Week 0, week 26, week 52, week 78
categorical status, descriptive
Secondary/protocol endpoint
Change in Physical Examination
Time frame:Week -2, week 52, week 78
descriptive
Secondary/protocol endpoint
Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)
Time frame:Weeks 0-83
Immunogenicity (ADA)
categorical status, event
Secondary/protocol endpoint
Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)
Time frame:Weeks 0-83
Immunogenicity (ADA)
categorical status, event
Secondary/protocol endpoint
Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Time frame:Weeks 0-83
Immunogenicity (ADA)
categorical status, event
Secondary/protocol endpoint
Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Time frame:Weeks 0-83
Immunogenicity (ADA)
categorical status, event
Secondary/protocol endpoint
Anti-semaglutide Binding Antibody Levels
Time frame:Weeks 0-83
Immunogenicity (ADA)
descriptive
Secondary/protocol endpoint
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Time frame:Weeks 0-83
Severe hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Secondary/protocol endpoint
Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Time frame:Weeks 0-83
Severe hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Secondary/protocol endpoint
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses
Time frame:Weeks 0-83
Plasma concentration (steady state)
concentration, descriptive
Other clinical outcomes
2 endpointsSecondary/registry result
Change in Eye Examination Category
Time frame:Week -2, week 52, week 78
categorical status, descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgLeft eye (week -2) | 302 | — |
| Left eye (week -2) | 130 | — |
| Left eye (week -2) | 27 | — |
| Left eye (week 52) | 249 | — |
| Left eye (week 52) | 119 | — |
| Left eye (week 52) | 25 | — |
| Left eye (week 78) | 261 | — |
| Left eye (week 78) | 135 | — |
| Left eye (week 78) | 21 | — |
| Right eye (week -2) | 309 | — |
| Right eye (week -2) | 126 | — |
| Right eye (week -2) | 24 | — |
| Right eye (week 52) | 247 | — |
| Right eye (week 52) | 122 | — |
| Right eye (week 52) | 24 | — |
| Right eye (week 78) | 258 | — |
| Right eye (week 78) | 136 | — |
| Right eye (week 78) | 23 | — |
| Oral Semaglutide 7 mgLeft eye (week -2) | 299 | — |
| Left eye (week -2) | 138 | — |
| Left eye (week -2) | 18 | — |
| Left eye (week 52) | 253 | — |
| Left eye (week 52) | 113 | — |
| Left eye (week 52) | 22 | — |
| Left eye (week 78) | 255 | — |
| Left eye (week 78) | 141 | — |
| Left eye (week 78) | 19 | — |
| Right eye (week -2) | 298 | — |
| Right eye (week -2) | 139 | — |
| Right eye (week -2) | 17 | — |
| Right eye (week 52) | 256 | — |
| Right eye (week 52) | 112 | — |
| Right eye (week 52) | 20 | — |
| Right eye (week 78) | 255 | — |
| Right eye (week 78) | 146 | — |
| Right eye (week 78) | 14 | — |
| Oral Semaglutide 14 mgLeft eye (week -2) | 305 | — |
| Left eye (week -2) | 129 | — |
| Left eye (week -2) | 23 | — |
| Left eye (week 52) | 270 | — |
| Left eye (week 52) | 101 | — |
| Left eye (week 52) | 20 | — |
| Left eye (week 78) | 273 | — |
| Left eye (week 78) | 130 | — |
| Left eye (week 78) | 17 | — |
| Right eye (week -2) | 308 | — |
| Right eye (week -2) | 126 | — |
| Right eye (week -2) | 23 | — |
| Right eye (week 52) | 271 | — |
| Right eye (week 52) | 103 | — |
| Right eye (week 52) | 17 | — |
| Right eye (week 78) | 275 | — |
| Right eye (week 78) | 128 | — |
| Right eye (week 78) | 17 | — |
| Sitagliptin 100 mgLeft eye (week -2) | 297 | — |
| Left eye (week -2) | 137 | — |
| Left eye (week -2) | 29 | — |
| Left eye (week 52) | 252 | — |
| Left eye (week 52) | 126 | — |
| Left eye (week 52) | 27 | — |
| Left eye (week 78) | 287 | — |
| Left eye (week 78) | 113 | — |
| Left eye (week 78) | 31 | — |
| Right eye (week -2) | 297 | — |
| Right eye (week -2) | 138 | — |
| Right eye (week -2) | 28 | — |
| Right eye (week 52) | 255 | — |
| Right eye (week 52) | 123 | — |
| Right eye (week 52) | 27 | — |
| Right eye (week 78) | 279 | — |
| Right eye (week 78) | 122 | — |
| Right eye (week 78) | 30 | — |
Secondary/protocol endpoint
Change in Eye Examination Category
Time frame:Week -2, week 52, week 78
categorical status, descriptive
Publications (9)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PharmacoEconomics - open2023 Jul (month)PMID37178435doi:10.1007/s41669-023-00416-zvia clinicaltrials gov reference derived + pubmed nct search
- PharmacoEconomics - open2022 May (month)PMID35064550doi:10.1007/s41669-021-00317-zvia CT.gov reference + pubmed nct search
- Diabetes therapy : research, treatment and education of diabetes and related disorders2021 Apr (month)PMID33660198doi:10.1007/s13300-020-00994-9via clinicaltrials gov reference derived + pubmed nct search
- Cardiovascular diabetology2020 Sep 30PMID32998732doi:10.1186/s12933-020-01106-4via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2020 Aug (month)PMID32267058doi:10.1111/dom.14054via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2020 Mar (month)PMID31903692doi:10.1111/dom.13955via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.