PIONEER 3

CompletedPhase 3Results posted

Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

242

Recruiting sites

Actual enrollment

1,864

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. 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

Semaglutide

Who this study enrolls

Type 2 diabetes

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

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

Patient-reported / QoL

Other clinical outcomes

Weight & body composition

14 endpoints

Secondary/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	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	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	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	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	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	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	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 endpoints

Primary/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	Mean · % 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-0.295% 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-0.395% 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	Mean · % 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	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	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	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	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	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	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	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	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	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 endpoints

Secondary/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	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	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	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	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	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	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	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	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 endpoints

Secondary/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	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	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	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 endpoints

Secondary/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	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	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	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	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	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	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	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	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	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	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	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	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	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 endpoints

Secondary/registry result

Change in Eye Examination Category

Time frame:Week -2, week 52, week 78

categorical status, descriptive

Posted result

Group	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

Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study.
PharmacoEconomics - open2023 Jul (month)PMID37178435doi:10.1007/s41669-023-00416-zvia clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme.
Diabetes, obesity & metabolism2022 Jul (month)PMID35373893doi:10.1111/dom.14710via CT.gov reference
Long-Term Cost Effectiveness of Oral Semaglutide Versus Empagliflozin and Sitagliptin for the Treatment of Type 2 Diabetes in the Swedish Setting.
PharmacoEconomics - open2022 May (month)PMID35064550doi:10.1007/s41669-021-00317-zvia CT.gov reference + pubmed nct search
Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A post hoc subgroup analysis of the PIONEER 1, 3, 4 and 8 trials.
Diabetes, obesity & metabolism2021 Dec (month)PMID34472698doi:10.1111/dom.14536via CT.gov reference
Oral Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses.
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
Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Cardiovascular diabetology2020 Sep 30PMID32998732doi:10.1186/s12933-020-01106-4via clinicaltrials gov reference derived + pubmed nct search
Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme.
Diabetes, obesity & metabolism2020 Aug (month)PMID32267058doi:10.1111/dom.14054via clinicaltrials gov reference derived + pubmed nct search
Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Diabetes, obesity & metabolism2020 Mar (month)PMID31903692doi:10.1111/dom.13955via clinicaltrials gov reference derived + pubmed nct search
Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial.
JAMA2019 Apr 16PMID30903796doi:10.1001/jama.2019.2942via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.