← Trials/Trial dossier/NCT02863419

PIONEER 4

CompletedPhase 3Results posted

Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Assets

Liraglutide / Semaglutide

Listed sites

108

Recruiting sites

—

Enrollment

711

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-9.5%

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 IDNCT02863419

Org study IDNN9924-4224

Secondary ID2015-005210-30

Secondary IDU1111-1176-6029WHO

Timeline

Milestones

Study start2016-08-10actual

Study first posted2016-08-11estimated

Primary completion2017-08-19actual

Study completion2018-03-30actual

Results first posted2019-11-07actual

Last update posted2022-07-20actual

Assets

Investigational agents

Liraglutide Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

•Male or female, age above or equal to 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 type 2 diabetes mellitus for at least 90 days prior to day of screening.

•HbA1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive)

•Stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) alone or in combination with a stable daily dose of a SGLT-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 days prior to day of screening (fixed-dose combinations are allowed)

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).For certain specific countries: Additional specific requirements apply

•Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

•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 and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)

•Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina 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

•Subjects with ALT (alanine aminotransferase) above 2.5 × upper normal limit (UNL)

•Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days

•Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation

•History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

•History of diabetic ketoacidosis

Endpoints (80)

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	Value (mean), Kg	95% CI
Oral Semaglutide 14 mgIn-trial	-4.4	—
On-treatment without rescue medication	-4.7	—
Liraglutide 1.8 mgIn-trial	-3.2	—
On-treatment without rescue medication	-3.3	—
PlaceboIn-trial	-0.6	—
On-treatment without rescue medication	-0.7	—

Mean treatment difference-1.295% CI-1.9 – -0.6p0.0003Pattern mixture model

Mean treatment difference-3.895% CI-4.7 – -3.0p<0.0001Pattern mixture model

Mean treatment difference-1.595% CI-2.2 – -0.9p<0.0001MMRM

Mean treatment difference-4.095% CI-4.8 – -3.2p<0.0001MMRM

Secondary/registry result

Change in Body Weight (Week 52)

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Oral Semaglutide 14 mg	-4.4	—
Liraglutide 1.8 mg	-3.1	—
Placebo	-1.0	—

Secondary/registry result

Change in Body Weight (%)

Time frame:Week 0, Week 26, Week 52

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Oral Semaglutide 14 mgWeek 26	-4.89	—
Week 52	-4.94	—
Liraglutide 1.8 mgWeek 26	-3.33	—
Week 52	-3.25	—
PlaceboWeek 26	-0.60	—
Week 52	-0.99	—

Secondary/registry result

Change in Body Mass Index

Time frame:Week 0, week 26, week 52

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kg/m^2	95% CI
Oral Semaglutide 14 mgWeek 26	-1.6	—
Week 52	-1.6	—
Liraglutide 1.8 mgWeek 26	-1.1	—
Week 52	-1.1	—
PlaceboWeek 26	-0.2	—
Week 52	-0.4	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 26, week 52

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Oral Semaglutide 14 mgWeek 26	-4.2	—
Week 52	-4.4	—
Liraglutide 1.8 mgWeek 26	-3.0	—
Week 52	-2.7	—
PlaceboWeek 26	-1.2	—
Week 52	-1.7	—

Secondary/registry result

Participants Who Achieve Weight Loss ≥5% (Yes/no)

Time frame:Week 26, week 52

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mgWeek 26	121	—
Week 26	157	—
Week 52	123	—
Week 52	152	—
Liraglutide 1.8 mgWeek 26	75	—
Week 26	196	—
Week 52	66	—
Week 52	203	—
PlaceboWeek 26	10	—
Week 26	124	—
Week 52	16	—
Week 52	117	—

Secondary/registry result

Participants Who Achieve Weight Loss ≥ 10% (Yes/no)

Time frame:Week 26, week 52

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mgWeek 26	39	—
Week 26	239	—
Week 52	45	—
Week 52	230	—
Liraglutide 1.8 mgWeek 26	16	—
Week 26	255	—
Week 52	20	—
Week 52	249	—
PlaceboWeek 26	0	—
Week 26	134	—
Week 52	4	—
Week 52	129	—

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 (Week 52)

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (%)

Time frame:Week 0, Week 26, Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index

Time frame:Week 0, week 26, week 52

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, week 26, week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieve Weight Loss ≥5% (Yes/no)

Time frame:Week 26, week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Who Achieve Weight Loss ≥ 10% (Yes/no)

Time frame:Week 26, week 52

≥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	Value (mean), Percentage of HbA1c	95% CI
Oral Semaglutide 14 mgIn-trial	-1.2	—
On-treatment without rescue medication	-1.4	—
Liraglutide 1.8 mgIn-trial	-1.1	—
On-treatment without rescue medication	-1.2	—
PlaceboIn-trial	-0.1	—
On-treatment without rescue medication	-0.1	—

Mean treatment difference-0.195% CI-0.3 – 0.0p<0.0001Pattern mixture model

Mean treatment difference-0.195% CI-0.3 – 0.0p0.0645Pattern mixture model

Mean treatment difference-1.195% CI-1.2 – -0.9p<0.0001Pattern mixture model

Mean treatment difference-0.295% CI-0.3 – -0.1p<0.0001MMRM

Mean treatment difference-0.295% CI-0.3 – -0.1p0.0056MMRM

Mean treatment difference-1.295% CI-1.4 – -1.0p0.0001MMRM

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 (Week 52)

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Oral Semaglutide 14 mg	-1.2	—
Liraglutide 1.8 mg	-0.9	—
Placebo	-0.1	—

Secondary/registry result

Change in Fasting Plasma Glucose

Time frame:Week 0, week 26, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Oral Semaglutide 14 mgWeek 26	-2.04	—
Week 52	-1.91	—
Liraglutide 1.8 mgWeek 26	-1.91	—
Week 52	-1.54	—
PlaceboWeek 26	-0.33	—
Week 52	-0.66	—

Secondary/registry result

Change in SMPG - Mean 7-point Profile

Time frame:Week 0, week 26, week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Oral Semaglutide 14 mgWeek 26	-2.2	—
Week 52	-2.2	—
Liraglutide 1.8 mgWeek 26	-2.0	—
Week 52	-1.8	—
PlaceboWeek 26	-0.7	—
Week 52	-0.9	—

Secondary/registry result

Change in SMPG - Mean Postprandial Increment Over All Meals

Time frame:Week 0, week 26, week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Oral Semaglutide 14 mgWeek 26	-0.7	—
Week 52	-0.5	—
Liraglutide 1.8 mgWeek 26	-0.4	—
Week 52	-0.5	—
PlaceboWeek 26	-0.2	—
Week 52	-0.4	—

Secondary/registry result

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)

Time frame:Week 26, week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mgWeek 26	188	—
Week 26	90	—
Week 52	167	—
Week 52	108	—
Liraglutide 1.8 mgWeek 26	168	—
Week 26	104	—
Week 52	148	—
Week 52	121	—
PlaceboWeek 26	19	—
Week 26	115	—
Week 52	20	—
Week 52	113	—

Secondary/registry result

Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no)

Time frame:Week 26, week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mgWeek 26	133	—
Week 26	145	—
Week 52	119	—
Week 52	156	—
Liraglutide 1.8 mgWeek 26	116	—
Week 26	156	—
Week 52	88	—
Week 52	181	—
PlaceboWeek 26	7	—
Week 26	127	—
Week 52	5	—
Week 52	128	—

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

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mgWeek 26	169	—
Week 26	109	—
Week 52	155	—
Week 52	120	—
Liraglutide 1.8 mgWeek 26	145	—
Week 26	126	—
Week 52	130	—
Week 52	139	—
PlaceboWeek 26	15	—
Week 26	119	—
Week 52	15	—
Week 52	118	—

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

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mgWeek 26	130	—
Week 26	148	—
Week 52	120	—
Week 52	155	—
Liraglutide 1.8 mgWeek 26	93	—
Week 26	178	—
Week 52	77	—
Week 52	192	—
PlaceboWeek 26	5	—
Week 26	129	—
Week 52	9	—
Week 52	124	—

Secondary/registry result

Time to Additional Anti-diabetic Medication

Time frame:Weeks 0-52

time to event, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mgWeek 0 to week 26	20	—
Week 0 to week 52	39	—
Liraglutide 1.8 mgWeek 0 to week 26	16	—
Week 0 to week 52	29	—
PlaceboWeek 0 to week 26	12	—
Week 0 to week 52	46	—

Hazard Ratio (HR)1.1795% CI0.75 – 1.80p0.4915Regression, Cox

Hazard Ratio (HR)0.3295% CI0.21 – 0.48p<0.0001Regression, Cox

Secondary/registry result

Time to Rescue Medication

Time frame:Weeks 0-52

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mgWeek 0 - week 26	10	—
Week 0 - week 52	20	—
Liraglutide 1.8 mgWeek 0 - week 26	9	—
Week 0 - week 52	18	—
PlaceboWeek 0 - week 26	11	—
Week 0 - week 52	43	—

Hazard Ratio (HR)1.1795% CI0.62 – 2.22p0.6252Regression, Cox

Hazard Ratio (HR)0.1595% CI0.09 – 0.26p<0.0001Regression, Cox

Secondary/protocol endpoint

Change in HbA1c (Week 52)

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:Week 0, week 26, week 52

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

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

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

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

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

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

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Secondary/protocol endpoint

Time to Additional Anti-diabetic Medication

Time frame:Weeks 0-52

time to event, event

Secondary/protocol endpoint

Time to Rescue Medication

Time frame:Weeks 0-52

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

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Oral Semaglutide 14 mgWeek 26	0.96	—
Week 52	0.98	—
Liraglutide 1.8 mgWeek 26	0.97	—
Week 52	0.98	—
PlaceboWeek 26	0.99	—
Week 52	1.02	—

Secondary/registry result

Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

Time frame:Week 0, week 26, week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Oral Semaglutide 14 mgWeek 26	0.95	—
Week 52	0.99	—
Liraglutide 1.8 mgWeek 26	0.97	—
Week 52	1.00	—
PlaceboWeek 26	0.99	—
Week 52	1.06	—

Secondary/registry result

Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline

Time frame:Week 0, week 26, week 52

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL cholesterol	95% CI
Oral Semaglutide 14 mgWeek 26	0.90	—
Week 52	0.87	—
Liraglutide 1.8 mgWeek 26	0.91	—
Week 52	0.90	—
PlaceboWeek 26	1.02	—
Week 52	0.98	—

Secondary/registry result

Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

Time frame:Week 0, week 26, week 52

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL-cholesterol	95% CI
Oral Semaglutide 14 mgWeek 26	1.02	—
Week 52	1.03	—
Liraglutide 1.8 mgWeek 26	1.02	—
Week 52	1.01	—
PlaceboWeek 26	1.02	—
Week 52	1.00	—

Secondary/registry result

Change in Triglycerides - Ratio to Baseline

Time frame:Week 0, week 26, week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Oral Semaglutide 14 mgWeek 26	0.89	—
Week 52	0.87	—
Liraglutide 1.8 mgWeek 26	0.91	—
Week 52	0.89	—
PlaceboWeek 26	1.01	—
Week 52	0.97	—

Secondary/registry result

Change in Free Fatty Acids - Ratio to Baseline

Time frame:Week 0, week 26, week 52

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of FFA	95% CI
Oral Semaglutide 14 mgWeek 26	0.94	—
Week 52	0.83	—
Liraglutide 1.8 mgWeek 26	0.95	—
Week 52	0.87	—
PlaceboWeek 26	1.06	—
Week 52	0.89	—

Secondary/registry result

Change in Pulse Rate

Time frame:Week 0, week 26, week 52

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats/min	95% CI
Oral Semaglutide 14 mgWeek 26	2	—
Week 52	2	—
Liraglutide 1.8 mgWeek 26	3	—
Week 52	3	—
PlaceboWeek 26	0	—
Week 52	0	—

Secondary/registry result

Change in SBP and DBP

Time frame:Week 0, week 26, week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Oral Semaglutide 14 mgSBP: 26 weeks	-4	—
SBP: 52 weeks	-3	—
DBP: 26 weeks	-1	—
DBP: 52 weeks	-1	—
Liraglutide 1.8 mgSBP: 26 weeks	-4	—
SBP: 52 weeks	-3	—
DBP: 26 weeks	-0	—
DBP: 52 weeks	-1	—
PlaceboSBP: 26 weeks	-2	—
SBP: 52 weeks	-0	—
DBP: 26 weeks	-1	—
DBP: 52 weeks	0	—

Secondary/protocol endpoint

Change in Total Cholesterol - Ratio to Baseline

Time frame:Week 0, week 26, week 52

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

Time frame:Week 0, week 26, week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline

Time frame:Week 0, week 26, week 52

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

Time frame:Week 0, week 26, week 52

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

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

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in Pulse Rate

Time frame:Week 0, week 26, week 52

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in SBP and DBP

Time frame:Week 0, week 26, week 52

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Patient-reported / QoL

2 endpoints

Secondary/registry result

Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed)

Time frame:Week 0, week 26, week 52

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
Oral Semaglutide 14 mgSatisfaction with treatment: wk 26	0.72	—
Satisfaction with treatment: wk 52	0.67	—
Feeling of unacceptably high blood sugars: wk 26	-1.94	—
Feeling of unacceptably high blood sugars: wk 52	-1.97	—
Feeling of unacceptably low blood sugars: wk 26	-0.18	—
Feeling of unacceptably low blood sugars: wk 52	-0.17	—
Convenience of treatment: wk 26	0.55	—
Convenience of treatment: wk 52	0.50	—
Flexibility of treatment: wk 26	0.45	—
Flexibility of treatment: wk 52	0.38	—
Satisfaction with understanding of diabetes: wk 26	0.66	—
Satisfaction with understanding of diabetes: wk 52	0.65	—
Recommending treatment to others: wk 26	0.57	—
Recommending treatment to others: wk 52	0.60	—
Satisfaction to continue present treatment: wk 26	0.64	—
Satisfaction to continue present treatment: wk 52	0.60	—
Total treatment satisfaction: wk 26	3.59	—
Total treatment satisfaction: wk 52	3.41	—
Liraglutide 1.8 mgSatisfaction with treatment: wk 26	0.73	—
Satisfaction with treatment: wk 52	0.70	—
Feeling of unacceptably high blood sugars: wk 26	-1.72	—
Feeling of unacceptably high blood sugars: wk 52	-1.71	—
Feeling of unacceptably low blood sugars: wk 26	0.03	—
Feeling of unacceptably low blood sugars: wk 52	-0.06	—
Convenience of treatment: wk 26	0.39	—
Convenience of treatment: wk 52	0.42	—
Flexibility of treatment: wk 26	0.43	—
Flexibility of treatment: wk 52	0.40	—
Satisfaction with understanding of diabetes: wk 26	0.52	—
Satisfaction with understanding of diabetes: wk 52	0.54	—
Recommending treatment to others: wk 26	0.63	—
Recommending treatment to others: wk 52	0.48	—
Satisfaction to continue present treatment: wk 26	0.74	—
Satisfaction to continue present treatment: wk 52	0.56	—
Total treatment satisfaction: wk 26	3.44	—
Total treatment satisfaction: wk 52	3.11	—
PlaceboSatisfaction with treatment: wk 26	0.28	—
Satisfaction with treatment: wk 52	0.48	—
Feeling of unacceptably high blood sugars: wk 26	-0.87	—
Feeling of unacceptably high blood sugars: wk 52	-1.04	—
Feeling of unacceptably low blood sugars: wk 26	-0.07	—
Feeling of unacceptably low blood sugars: wk 52	-0.14	—
Convenience of treatment: wk 26	0.17	—
Convenience of treatment: wk 52	0.21	—
Flexibility of treatment: wk 26	0.09	—
Flexibility of treatment: wk 52	0.14	—
Satisfaction with understanding of diabetes: wk 26	0.38	—
Satisfaction with understanding of diabetes: wk 52	0.27	—
Recommending treatment to others: wk 26	0.10	—
Recommending treatment to others: wk 52	0.02	—
Satisfaction to continue present treatment: wk 26	0.22	—
Satisfaction to continue present treatment: wk 52	0.11	—
Total treatment satisfaction: wk 26	1.24	—
Total treatment satisfaction: wk 52	1.23	—

Secondary/protocol endpoint

Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed)

Time frame:Week 0, week 26, week 52

change from baseline, improvement

Safety / tolerability / PK

24 endpoints

Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product

Time frame:Weeks 0-57

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide 14 mg	973	—
Liraglutide 1.8 mg	927	—
Placebo	300	—

Secondary/registry result

Change in Amylase - Ratio to Baseline

Time frame:Week 0, week 26, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of amylase	95% CI
Oral Semaglutide 14 mgWeek 26	1.13	—
Week 52	1.14	—
Liraglutide 1.8 mgWeek 26	1.11	—
Week 52	1.10	—
PlaceboWeek 26	0.99	—
Week 52	0.98	—

Secondary/registry result

Change in Lipase - Ratio to Baseline

Time frame:Week 0, week 26, week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lipase	95% CI
Oral Semaglutide 14 mgWeek 26	1.33	—
Week 52	1.28	—
Liraglutide 1.8 mgWeek 26	1.40	—
Week 52	1.32	—
PlaceboWeek 26	0.99	—
Week 52	0.96	—

Secondary/registry result

Change in ECG Evaluation

Time frame:Week 0, week 26, week 52

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mgNormal (week 0) to normal (week 26)	130	—
Normal (week 0) to abnormal NCS (week 26)	19	—
Normal (week 0) to abnormal CS (week 26)	0	—
Abnormal NCS (week 0) to normal (week 26)	15	—
Abnormal NCS (week 0) to abnormal NCS (week 26)	81	—
Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Abnormal CS (week 0) to normal (week 26)	0	—
Abnormal CS (week 0) to abnormal NCS (week 26)	2	—
Abnormal CS (week 0) to abnormal CS (week 26)	3	—
Normal (week 0) to Normal (week 52)	113	—
Normal (week 0) to Abnormal NCS (week 52)	31	—
Normal (week 0) to Abnormal CS (week 52)	1	—
Abnormal NCS (week 0) to Normal (week 52)	19	—
Abnormal NCS (week 0) to Abnormal NCS (week 52)	73	—
Abnormal NCS (week 0) to Abnormal CS (week 52)	0	—
Abnormal CS (week 0) to Normal (week 52)	0	—
Abnormal CS (week 0) to Abnormal NCS (week 52)	1	—
Abnormal CS (week 0) to Abnormal CS (week 52)	3	—
Liraglutide 1.8 mgNormal (week 0) to normal (week 26)	123	—
Normal (week 0) to abnormal NCS (week 26)	20	—
Normal (week 0) to abnormal CS (week 26)	0	—
Abnormal NCS (week 0) to normal (week 26)	27	—
Abnormal NCS (week 0) to abnormal NCS (week 26)	75	—
Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Abnormal CS (week 0) to normal (week 26)	2	—
Abnormal CS (week 0) to abnormal NCS (week 26)	2	—
Abnormal CS (week 0) to abnormal CS (week 26)	7	—
Normal (week 0) to Normal (week 52)	123	—
Normal (week 0) to Abnormal NCS (week 52)	14	—
Normal (week 0) to Abnormal CS (week 52)	1	—
Abnormal NCS (week 0) to Normal (week 52)	26	—
Abnormal NCS (week 0) to Abnormal NCS (week 52)	73	—
Abnormal NCS (week 0) to Abnormal CS (week 52)	0	—
Abnormal CS (week 0) to Normal (week 52)	3	—
Abnormal CS (week 0) to Abnormal NCS (week 52)	1	—
Abnormal CS (week 0) to Abnormal CS (week 52)	5	—
PlaceboNormal (week 0) to normal (week 26)	67	—
Normal (week 0) to abnormal NCS (week 26)	6	—
Normal (week 0) to abnormal CS (week 26)	0	—
Abnormal NCS (week 0) to normal (week 26)	19	—
Abnormal NCS (week 0) to abnormal NCS (week 26)	33	—
Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Abnormal CS (week 0) to normal (week 26)	2	—
Abnormal CS (week 0) to abnormal NCS (week 26)	1	—
Abnormal CS (week 0) to abnormal CS (week 26)	0	—
Normal (week 0) to Normal (week 52)	64	—
Normal (week 0) to Abnormal NCS (week 52)	5	—
Normal (week 0) to Abnormal CS (week 52)	1	—
Abnormal NCS (week 0) to Normal (week 52)	14	—
Abnormal NCS (week 0) to Abnormal NCS (week 52)	37	—
Abnormal NCS (week 0) to Abnormal CS (week 52)	0	—
Abnormal CS (week 0) to Normal (week 52)	2	—
Abnormal CS (week 0) to Abnormal NCS (week 52)	1	—
Abnormal CS (week 0) to Abnormal CS (week 52)	0	—

Secondary/registry result

Change in Physical Examination

Time frame:Week -2, week 52

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mg1) Cardiovascular system (Week -2)	260	—
1) Cardiovascular system (Week -2)	23	—
1) Cardiovascular system (Week -2)	2	—
1) Cardiovascular system (Week 52)	255	—
1) Cardiovascular system (Week 52)	19	—
1) Cardiovascular system (Week 52)	1	—
2) Central and peripheral nervous system (Week -2)	258	—
2) Central and peripheral nervous system (Week -2)	16	—
2) Central and peripheral nervous system (Week -2)	11	—
2) Central and peripheral nervous system (Week 52)	247	—
2) Central and peripheral nervous system (Week 52)	20	—
2) Central and peripheral nervous system (Week 52)	8	—
3) Gastrointestinal system, incl. mouth (Week -2)	275	—
3) Gastrointestinal system, incl. mouth (Week -2)	10	—
3) Gastrointestinal system, incl. mouth (Week -2)	0	—
3) Gastrointestinal system, incl. mouth (Week 52)	266	—
3) Gastrointestinal system, incl. mouth (Week 52)	9	—
3) Gastrointestinal system, incl. mouth (Week 52)	0	—
4) General appearance (Week -2)	203	—
4) General appearance (Week -2)	67	—
4) General appearance (Week -2)	15	—
4) General appearance (Week 52)	208	—
4) General appearance (Week 52)	59	—
4) General appearance (Week 52)	8	—
5) Head, ears, eyes, nose, throat, neck (Week -2)	275	—
5) Head, ears, eyes, nose, throat, neck (Week -2)	9	—
5) Head, ears, eyes, nose, throat, neck (Week -2)	1	—
5) Head, ears, eyes, nose, throat, neck (Week 52)	267	—
5) Head, ears, eyes, nose, throat, neck (Week 52)	8	—
5) Head, ears, eyes, nose, throat, neck (Week 52)	0	—
6) Lymph node palpation (Week -2)	285	—
6) Lymph node palpation (Week -2)	0	—
6) Lymph node palpation (Week -2)	0	—
6) Lymph node palpation (Week 52)	275	—
6) Lymph node palpation (Week 52)	0	—
6) Lymph node palpation (Week 52)	0	—
7) Musculoskeletal system (Week -2)	268	—
7) Musculoskeletal system (Week -2)	14	—
7) Musculoskeletal system (Week -2)	3	—
7) Musculoskeletal system (Week 52)	262	—
7) Musculoskeletal system (Week 52)	11	—
7) Musculoskeletal system (Week 52)	2	—
8) Respiratory system (Week -2)	282	—
8) Respiratory system (Week -2)	3	—
8) Respiratory system (Week -2)	0	—
8) Respiratory system (Week 52)	273	—
8) Respiratory system (Week 52)	2	—
8) Respiratory system (Week 52)	0	—
9) Skin (Week -2)	243	—
9) Skin (Week -2)	40	—
9) Skin (Week -2)	2	—
9) Skin (Week 52)	243	—
9) Skin (Week 52)	30	—
9) Skin (Week 52)	2	—
10) Thyroid gland (Week -2)	276	—
10) Thyroid gland (Week -2)	5	—
10) Thyroid gland (Week -2)	4	—
10) Thyroid gland (Week 52)	267	—
10) Thyroid gland (Week 52)	5	—
10) Thyroid gland (Week 52)	3	—
Liraglutide 1.8 mg1) Cardiovascular system (Week -2)	249	—
1) Cardiovascular system (Week -2)	26	—
1) Cardiovascular system (Week -2)	9	—
1) Cardiovascular system (Week 52)	236	—
1) Cardiovascular system (Week 52)	24	—
1) Cardiovascular system (Week 52)	9	—
2) Central and peripheral nervous system (Week -2)	254	—
2) Central and peripheral nervous system (Week -2)	16	—
2) Central and peripheral nervous system (Week -2)	14	—
2) Central and peripheral nervous system (Week 52)	239	—
2) Central and peripheral nervous system (Week 52)	20	—
2) Central and peripheral nervous system (Week 52)	10	—
3) Gastrointestinal system, incl. mouth (Week -2)	271	—
3) Gastrointestinal system, incl. mouth (Week -2)	13	—
3) Gastrointestinal system, incl. mouth (Week -2)	0	—
3) Gastrointestinal system, incl. mouth (Week 52)	260	—
3) Gastrointestinal system, incl. mouth (Week 52)	9	—
3) Gastrointestinal system, incl. mouth (Week 52)	0	—
4) General appearance (Week -2)	212	—
4) General appearance (Week -2)	54	—
4) General appearance (Week -2)	18	—
4) General appearance (Week 52)	204	—
4) General appearance (Week 52)	55	—
4) General appearance (Week 52)	10	—
5) Head, ears, eyes, nose, throat, neck (Week -2)	269	—
5) Head, ears, eyes, nose, throat, neck (Week -2)	13	—
5) Head, ears, eyes, nose, throat, neck (Week -2)	2	—
5) Head, ears, eyes, nose, throat, neck (Week 52)	258	—
5) Head, ears, eyes, nose, throat, neck (Week 52)	10	—
5) Head, ears, eyes, nose, throat, neck (Week 52)	0	—
6) Lymph node palpation (Week -2)	283	—
6) Lymph node palpation (Week -2)	1	—
6) Lymph node palpation (Week -2)	0	—
6) Lymph node palpation (Week 52)	268	—
6) Lymph node palpation (Week 52)	1	—
6) Lymph node palpation (Week 52)	0	—
7) Musculoskeletal system (Week -2)	264	—
7) Musculoskeletal system (Week -2)	17	—
7) Musculoskeletal system (Week -2)	3	—
7) Musculoskeletal system (Week 52)	257	—
7) Musculoskeletal system (Week 52)	10	—
7) Musculoskeletal system (Week 52)	1	—
8) Respiratory system (Week -2)	278	—
8) Respiratory system (Week -2)	5	—
8) Respiratory system (Week -2)	1	—
8) Respiratory system (Week 52)	262	—
8) Respiratory system (Week 52)	6	—
8) Respiratory system (Week 52)	1	—
9) Skin (Week -2)	243	—
9) Skin (Week -2)	36	—
9) Skin (Week -2)	5	—
9) Skin (Week 52)	235	—
9) Skin (Week 52)	30	—
9) Skin (Week 52)	4	—
10) Thyroid gland (Week -2)	277	—
10) Thyroid gland (Week -2)	5	—
10) Thyroid gland (Week -2)	2	—
10) Thyroid gland (Week 52)	262	—
10) Thyroid gland (Week 52)	6	—
10) Thyroid gland (Week 52)	1	—
Placebo1) Cardiovascular system (Week -2)	128	—
1) Cardiovascular system (Week -2)	12	—
1) Cardiovascular system (Week -2)	2	—
1) Cardiovascular system (Week 52)	118	—
1) Cardiovascular system (Week 52)	15	—
1) Cardiovascular system (Week 52)	0	—
2) Central and peripheral nervous system (Week -2)	123	—
2) Central and peripheral nervous system (Week -2)	13	—
2) Central and peripheral nervous system (Week -2)	6	—
2) Central and peripheral nervous system (Week 52)	115	—
2) Central and peripheral nervous system (Week 52)	11	—
2) Central and peripheral nervous system (Week 52)	7	—
3) Gastrointestinal system, incl. mouth (Week -2)	133	—
3) Gastrointestinal system, incl. mouth (Week -2)	9	—
3) Gastrointestinal system, incl. mouth (Week -2)	0	—
3) Gastrointestinal system, incl. mouth (Week 52)	123	—
3) Gastrointestinal system, incl. mouth (Week 52)	10	—
3) Gastrointestinal system, incl. mouth (Week 52)	0	—
4) General appearance (Week -2)	109	—
4) General appearance (Week -2)	22	—
4) General appearance (Week -2)	11	—
4) General appearance (Week 52)	105	—
4) General appearance (Week 52)	20	—
4) General appearance (Week 52)	8	—
5) Head, ears, eyes, nose, throat, neck (Week -2)	138	—
5) Head, ears, eyes, nose, throat, neck (Week -2)	3	—
5) Head, ears, eyes, nose, throat, neck (Week -2)	1	—
5) Head, ears, eyes, nose, throat, neck (Week 52)	129	—
5) Head, ears, eyes, nose, throat, neck (Week 52)	3	—
5) Head, ears, eyes, nose, throat, neck (Week 52)	0	—
6) Lymph node palpation (Week -2)	142	—
6) Lymph node palpation (Week -2)	0	—
6) Lymph node palpation (Week -2)	0	—
6) Lymph node palpation (Week 52)	133	—
6) Lymph node palpation (Week 52)	0	—
6) Lymph node palpation (Week 52)	0	—
7) Musculoskeletal system (Week -2)	131	—
7) Musculoskeletal system (Week -2)	10	—
7) Musculoskeletal system (Week -2)	1	—
7) Musculoskeletal system (Week 52)	124	—
7) Musculoskeletal system (Week 52)	7	—
7) Musculoskeletal system (Week 52)	1	—
8) Respiratory system (Week -2)	140	—
8) Respiratory system (Week -2)	0	—
8) Respiratory system (Week -2)	2	—
8) Respiratory system (Week 52)	131	—
8) Respiratory system (Week 52)	0	—
8) Respiratory system (Week 52)	2	—
9) Skin (Week -2)	122	—
9) Skin (Week -2)	17	—
9) Skin (Week -2)	3	—
9) Skin (Week 52)	114	—
9) Skin (Week 52)	17	—
9) Skin (Week 52)	2	—
10) Thyroid gland (Week -2)	132	—
10) Thyroid gland (Week -2)	8	—
10) Thyroid gland (Week -2)	2	—
10) Thyroid gland (Week 52)	127	—
10) Thyroid gland (Week 52)	4	—
10) Thyroid gland (Week 52)	2	—

Secondary/registry result

Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)

Time frame:Weeks 0-57

Immunogenicity (ADA)

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mg	0	—

Secondary/registry result

Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)

Time frame:Weeks 0-57

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mg	0	—

Secondary/registry result

Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)

Time frame:Week 0-57

Immunogenicity (ADA)

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mg	0	—

Secondary/registry result

Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)

Time frame:Weeks 0-57

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mg	0	—

Secondary/registry result

Anti-semaglutide Binding Antibody Levels

Time frame:Weeks 0-57

Immunogenicity (ADA)

descriptive

Secondary/registry result

Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-57

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Oral Semaglutide 14 mg	2	—
Liraglutide 1.8 mg	9	—
Placebo	3	—

Secondary/registry result

Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-57

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mg	2	—
Liraglutide 1.8 mg	7	—
Placebo	3	—

Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product

Time frame:Weeks 0-57

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change in Amylase - Ratio to Baseline

Time frame:Week 0, week 26, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Lipase - Ratio to Baseline

Time frame:Week 0, week 26, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in ECG Evaluation

Time frame:Week 0, week 26, week 52

categorical status, descriptive

Secondary/protocol endpoint

Change in Physical Examination

Time frame:Week -2, week 52

descriptive

Secondary/protocol endpoint

Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)

Time frame:Weeks 0-57

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)

Time frame:Weeks 0-57

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)

Time frame:Week 0-57

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 0-57

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Anti-semaglutide Binding Antibody Levels

Time frame:Weeks 0-57

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-57

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 0-57

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Other clinical outcomes

2 endpoints

Secondary/registry result

Change in Eye Examination Category

Time frame:Week -2, Week 52

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 14 mgLeft eye - Normal to Normal	130	—
Left eye - Normal to Abnormal NCS	10	—
Left eye - Normal to Abnormal CS	4	—
Left eye - Abnormal NCS to normal	15	—
Left eye - Abnormal NCS to abnormal NCS	63	—
Left eye - Abnormal NCS to abnormal CS	1	—
Left eye - Abnormal CS to normal	1	—
Left eye - Abnormal CS to abnormal NCS	5	—
Left eye - Abnormal CS to abnormal CS	7	—
Right eye - Normal to Normal	127	—
Right eye - Normal to Abnormal NCS	10	—
Right eye - Normal to Abnormal CS	3	—
Right eye - Abnormal NCS to Normal	16	—
Right eye - Abnormal NCS to Abnormal NCS	64	—
Right eye - Abnormal NCS to Abnormal CS	2	—
Right eye - Abnormal CS to Normal	2	—
Right eye - Abnormal CS to Abnormal NCS	5	—
Right eye - Abnormal CS to Abnormal CS	7	—
Liraglutide 1.8 mgLeft eye - Normal to Normal	144	—
Left eye - Normal to Abnormal NCS	15	—
Left eye - Normal to Abnormal CS	4	—
Left eye - Abnormal NCS to normal	13	—
Left eye - Abnormal NCS to abnormal NCS	43	—
Left eye - Abnormal NCS to abnormal CS	1	—
Left eye - Abnormal CS to normal	3	—
Left eye - Abnormal CS to abnormal NCS	3	—
Left eye - Abnormal CS to abnormal CS	12	—
Right eye - Normal to Normal	150	—
Right eye - Normal to Abnormal NCS	13	—
Right eye - Normal to Abnormal CS	4	—
Right eye - Abnormal NCS to Normal	12	—
Right eye - Abnormal NCS to Abnormal NCS	42	—
Right eye - Abnormal NCS to Abnormal CS	1	—
Right eye - Abnormal CS to Normal	3	—
Right eye - Abnormal CS to Abnormal NCS	2	—
Right eye - Abnormal CS to Abnormal CS	11	—
PlaceboLeft eye - Normal to Normal	57	—
Left eye - Normal to Abnormal NCS	5	—
Left eye - Normal to Abnormal CS	2	—
Left eye - Abnormal NCS to normal	5	—
Left eye - Abnormal NCS to abnormal NCS	38	—
Left eye - Abnormal NCS to abnormal CS	1	—
Left eye - Abnormal CS to normal	0	—
Left eye - Abnormal CS to abnormal NCS	2	—
Left eye - Abnormal CS to abnormal CS	8	—
Right eye - Normal to Normal	57	—
Right eye - Normal to Abnormal NCS	7	—
Right eye - Normal to Abnormal CS	2	—
Right eye - Abnormal NCS to Normal	6	—
Right eye - Abnormal NCS to Abnormal NCS	37	—
Right eye - Abnormal NCS to Abnormal CS	1	—
Right eye - Abnormal CS to Normal	1	—
Right eye - Abnormal CS to Abnormal NCS	1	—
Right eye - Abnormal CS to Abnormal CS	6	—

Secondary/protocol endpoint

Change in Eye Examination Category

Time frame:Week -2, Week 52

categorical status, descriptive

Publications (8)

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

Early use of oral semaglutide in the UK: A cost-effectiveness analysis versus continuing metformin and SGLT-2 inhibitor therapy.
BMJ open2023 Sep 29PMID37775297doi:10.1136/bmjopen-2022-070473via 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
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 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
Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial.
Lancet (London, England)2019 Jul 6PMID31186120doi:10.1016/S0140-6736(19)31271-1via CT.gov reference + 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.