SUSTAIN

CompletedPhase 3Results posted

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes. A 30-week Randomised, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-centre and Multi-national Trial

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

868

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03061214

Org study IDNN9535-4114

Secondary IDCTR20161003China Drug Trials (China)

Secondary IDU1111-1149-0432World Health Organization (WHO)

Timeline

Milestones

Study first posted2017-02-23actual

Study start2017-08-28actual

Primary completion2019-03-14actual

Study completion2019-04-15actual

Results first posted2020-04-09actual

Last update posted2021-03-02actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility 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 equal to or above 18 years at the time of signing informed consent - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 60 days prior to screening with metformin equal to or above 1500 mg (or maximum tolerated dose equal to or above 1000 mg). Stable is defined as unchanged medication and unchanged daily dose - HbA1c 7.0 - 10.5 % (53-91 mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measure as required by local regulation or practice) - Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 60 days before screening. An exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV

Endpoints (148)

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

Renal / kidney

MASH / liver

Patient-reported / QoL

Other (unclassified)

Weight & body composition

10 endpoints

Secondary/registry result

Change in Body Weight

Time frame:Week 0, week 30

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (kg)	95% CI
Semaglutide 0.5 mg	-3.0	—
Semaglutide 1.0 mg	-4.2	—
Sitagliptin	-0.4	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 30

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeter (cm)	95% CI
Semaglutide 0.5 mg	-2.7	—
Semaglutide 1.0 mg	-4.0	—
Sitagliptin	-0.7	—

Secondary/registry result

Change in BMI

Time frame:Week 0, week 30

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram per square meter (kg/m^2)	95% CI
Semaglutide 0.5 mg	-1.1	—
Semaglutide 1.0 mg	-1.6	—
Sitagliptin	-0.1	—

Secondary/registry result

Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5%

Time frame:Week 30

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 0.5 mgYes	36.6	—
No	63.4	—
Semaglutide 1.0 mgYes	52.7	—
No	47.3	—
SitagliptinYes	5.9	—
No	94.1	—

Secondary/registry result

Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10%

Time frame:Week 30

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 0.5 mgYes	9.7	—
No	90.3	—
Semaglutide 1.0 mgYes	17.2	—
No	82.8	—
SitagliptinYes	0.4	—
No	99.6	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, week 30

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, week 30

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

Time frame:Week 0, week 30

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5%

Time frame:Week 30

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10%

Time frame:Week 30

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

27 endpoints

Primary/registry result

Change in HbA1c

Time frame:Week 0, week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of glycosylated haemoglobin	95% CI
Semaglutide 0.5 mgOn-treatment without rescue medication obs. period	-1.5	—
In-trial observation period	-1.5	—
Semaglutide 1.0 mgOn-treatment without rescue medication obs. period	-1.8	—
In-trial observation period	-1.7	—
SitagliptinOn-treatment without rescue medication obs. period	-1.0	—
In-trial observation period	-0.9	—

Treatment difference-0.8595% CI-1.00 – -0.70p<.0001Mixed Models Analysis

Treatment difference-0.5195% CI-0.66 – -0.36p<.0001Mixed Models Analysis

Treatment difference-0.8595% CI-1.00 – -0.70p<.0001Mixed Models Analysis

Treatment difference-0.5195% CI-0.66 – -0.36p<.0001Mixed Models Analysis

Primary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Semaglutide 0.5 mg	-2.18	—
Semaglutide 1.0 mg	-2.62	—
Sitagliptin	-1.0	—

Secondary/registry result

Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile

Time frame:Week 0, week 30

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Semaglutide 0.5 mg	-2.5	—
Semaglutide 1.0 mg	-3.3	—
Sitagliptin	-1.6	—

Secondary/registry result

Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals

Time frame:Week 0, week 30

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Semaglutide 0.5 mg	-1.0	—
Semaglutide 1.0 mg	-1.2	—
Sitagliptin	-0.7	—

Secondary/registry result

Change in Fasting Insulin - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting insulin	95% CI
Semaglutide 0.5 mg	1.06	—
Semaglutide 1.0 mg	1.03	—
Sitagliptin	1.01	—

Secondary/registry result

Change in Fasting C-peptide - Ratio to Baseline

Time frame:Week 0, week 30

C-peptide AUC

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting C-peptide	95% CI
Semaglutide 0.5 mg	1.08	—
Semaglutide 1.0 mg	1.05	—
Sitagliptin	1.0	—

Secondary/registry result

Change in Fasting Proinsulin - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting proinsulin	95% CI
Semaglutide 0.5 mg	0.68	—
Semaglutide 1.0 mg	0.59	—
Sitagliptin	0.81	—

Secondary/registry result

Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting proinsulin/insulin	95% CI
Semaglutide 0.5 mg	0.63	—
Semaglutide 1.0 mg	0.57	—
Sitagliptin	0.80	—

Secondary/registry result

Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting HOMA-B	95% CI
Semaglutide 0.5 mg	1.81	—
Semaglutide 1.0 mg	1.95	—
Sitagliptin	1.25	—

Secondary/registry result

Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline

Time frame:Week 0, week 30

HOMA-IR (insulin sensitivity)

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting HOMA-IR	95% CI
Semaglutide 0.5 mg	0.81	—
Semaglutide 1.0 mg	0.74	—
Sitagliptin	0.90	—

Secondary/registry result

Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no)

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 0.5 mgYes	74.5	—
No	25.5	—
Semaglutide 1.0 mgYes	84.0	—
No	16.0	—
SitagliptinYes	49.6	—
No	50.4	—

Secondary/registry result

Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no)

Time frame:Week 30

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 0.5 mgYes	60.4	—
No	39.6	—
Semaglutide 1.0 mgYes	70.6	—
No	29.4	—
SitagliptinYes	31.6	—
No	68.4	—

Secondary/registry result

Percentage of Participants That Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia and no Weight Gain

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 0.5 mgYes	66.0	—
No	34.0	—
Semaglutide 1.0 mgYes	76.9	—
No	23.1	—
SitagliptinYes	33.7	—
No	66.3	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile

Time frame:Week 0, week 30

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals

Time frame:Week 0, week 30

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Insulin - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Secondary/protocol endpoint

Change in Fasting C-peptide - Ratio to Baseline

Time frame:Week 0, week 30

C-peptide AUC

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Proinsulin - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Secondary/protocol endpoint

Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Secondary/protocol endpoint

Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline

Time frame:Week 0, week 30

HOMA-IR (insulin sensitivity)

ratio, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no)

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no)

Time frame:Week 30

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants That Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia and no Weight Gain

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Urinalysis Parameter: Glucose

Time frame:Week 0, week 30

categorical status, improvement

MASH / liver

7 endpoints

Secondary/registry result

Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of alkaline phosphatase	95% CI
Semaglutide 0.5 mg	0.92	—
Semaglutide 1.0 mg	0.91	—
Sitagliptin	0.92	—

Secondary/registry result

Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline

Time frame:Week 0, week 30

ALT, change

ratio, improvement

LOINC 1742-6

Posted result

Group	Value (geometric_mean), Ratio of alanine aminotransferase	95% CI
Semaglutide 0.5 mg	0.86	—
Semaglutide 1.0 mg	0.83	—
Sitagliptin	0.95	—

Secondary/registry result

Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline

Time frame:Week 0, week 30

AST, change

ratio, improvement

LOINC 1920-8

Posted result

Group	Value (geometric_mean), Ratio of aspartate aminotransferase	95% CI
Semaglutide 0.5 mg	0.92	—
Semaglutide 1.0 mg	0.88	—
Sitagliptin	0.99	—

Secondary/protocol endpoint

Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Secondary/protocol endpoint

Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline

Time frame:Week 0, week 30

ALT, change

ratio, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline

Time frame:Week 0, week 30

AST, change

ratio, improvement

LOINC 1920-8

Secondary/protocol endpoint/low confidence

Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Renal / kidney

10 endpoints

Secondary/registry result

Change in Biochemistry Parameter: Albumin - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of albumin	95% CI
Semaglutide 0.5 mg	1.02	—
Semaglutide 1.0 mg	1.02	—
Sitagliptin	1.01	—

Secondary/registry result

Change in Biochemistry Parameter: Creatinine - Ratio to Baseline

Time frame:Week -2, week 30

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of creatinine	95% CI
Semaglutide 0.5 mg	1.08	—
Semaglutide 1.0 mg	1.07	—
Sitagliptin	1.05	—

Secondary/registry result

Change in Biochemistry Parameter: Urea - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of urea	95% CI
Semaglutide 0.5 mg	1.01	—
Semaglutide 1.0 mg	1.02	—
Sitagliptin	1.01	—

Secondary/registry result

Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline

Time frame:Week 0, week 30

eGFR, change

ratio, improvement

LOINC 98979-8

Posted result

Group	Value (geometric_mean), Ratio of eGFR	95% CI
Semaglutide 0.5 mg	0.92	—
Semaglutide 1.0 mg	0.92	—
Sitagliptin	0.94	—

Secondary/registry result

Change in Urinalysis Parameter - UACR-ratio to Baseline

Time frame:Week 0, week 30

uACR, % change

ratio, improvement

LOINC 9318-7

Posted result

Group	Value (geometric_mean), Ratio of UACR	95% CI
Semaglutide 0.5 mg	0.77	—
Semaglutide 1.0 mg	0.69	—
Sitagliptin	0.89	—

Secondary/protocol endpoint

Change in Biochemistry Parameter: Creatinine - Ratio to Baseline

Time frame:Week -2, week 30

ratio, improvement

Secondary/protocol endpoint

Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline

Time frame:Week 0, week 30

eGFR, change

ratio, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in Urinalysis Parameter - UACR-ratio to Baseline

Time frame:Week 0, week 30

uACR, change

ratio, improvement

LOINC 9318-7

Secondary/protocol endpoint

Change in Urinalysis Parameter: Protein

Time frame:Week 0, week 30

categorical status, improvement

Secondary/protocol endpoint

Change in Urinalysis Parameter: Erythrocytes

Time frame:Week 0, week 30

categorical status, descriptive

Cardiometabolic biomarkers

19 endpoints

Secondary/registry result

Change in Fasting Glucagon - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting glucagon	95% CI
Semaglutide 0.5 mg	0.89	—
Semaglutide 1.0 mg	0.89	—
Sitagliptin	0.93	—

Secondary/registry result

Change in High-sensitivity CRP - Ratio to Baseline

Time frame:Week 0, week 30

hs-CRP, change

ratio, improvement

LOINC 30522-7

Posted result

Group	Value (geometric_mean), Ratio of high-sensitivity CRP	95% CI
Semaglutide 0.5 mg	0.73	—
Semaglutide 1.0 mg	0.64	—
Sitagliptin	0.96	—

Secondary/registry result

Change in Fasting Total Cholesterol - Ratio to Baseline

Time frame:Week 0, week 30

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of fasting total cholesterol	95% CI
Semaglutide 0.5 mg	0.95	—
Semaglutide 1.0 mg	0.95	—
Sitagliptin	1.00	—

Secondary/registry result

Change in Fasting LDL Cholesterol - Ratio to Baseline

Time frame:Week 0, week 30

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of fasting LDL cholesterol	95% CI
Semaglutide 0.5 mg	0.97	—
Semaglutide 1.0 mg	0.99	—
Sitagliptin	1.01	—

Secondary/registry result

Change in Fasting VLDL Cholesterol - Ratio to Baseline

Time frame:Week 0, week 30

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting VLDL cholesterol	95% CI
Semaglutide 0.5 mg	0.86	—
Semaglutide 1.0 mg	0.82	—
Sitagliptin	0.93	—

Secondary/registry result

Change in Fasting HDL Cholesterol - Ratio to Baseline

Time frame:Week 0, week 30

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of fasting HDL cholesterol	95% CI
Semaglutide 0.5 mg	1.00	—
Semaglutide 1.0 mg	1.02	—
Sitagliptin	1.01	—

Secondary/registry result

Change in Fasting Triglycerides - Ratio to Baseline

Time frame:Week 0, week 30

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of fasting triglycerides	95% CI
Semaglutide 0.5 mg	0.86	—
Semaglutide 1.0 mg	0.81	—
Sitagliptin	0.93	—

Secondary/registry result

Change in Free Fatty Acids - Ratio to Baseline

Time frame:Week 0, week 30

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of free fatty acids	95% CI
Semaglutide 0.5 mg	0.78	—
Semaglutide 1.0 mg	0.78	—
Sitagliptin	0.87	—

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 30

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Semaglutide 0.5 mgSystolic blood pressure	-3.4	—
Diastolic blood pressure	-0.7	—
Semaglutide 1.0 mgSystolic blood pressure	-6.5	—
Diastolic blood pressure	-1.5	—
SitagliptinSystolic blood pressure	-0.9	—
Diastolic blood pressure	-0.8	—

Secondary/registry result

Change in Clinical Evaluation: Pulse

Time frame:Week 0, week 30

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute (beats/min)	95% CI
Semaglutide 0.5 mg	3.7	—
Semaglutide 1.0 mg	3.7	—
Sitagliptin	0.2	—

Secondary/protocol endpoint

Change in High-sensitivity CRP - Ratio to Baseline

Time frame:Week 0, week 30

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Fasting Total Cholesterol - Ratio to Baseline

Time frame:Week 0, week 30

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Fasting LDL Cholesterol - Ratio to Baseline

Time frame:Week 0, week 30

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Fasting VLDL Cholesterol - Ratio to Baseline

Time frame:Week 0, week 30

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Fasting HDL Cholesterol - Ratio to Baseline

Time frame:Week 0, week 30

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Fasting Triglycerides - Ratio to Baseline

Time frame:Week 0, week 30

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Free Fatty Acids - Ratio to Baseline

Time frame:Week 0, week 30

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 30

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

Change in Clinical Evaluation: Pulse

Time frame:Week 0, week 30

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score

Time frame:Week 0, week 30

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 0.5 mgPhysical component summary (PCS)	1.3	—
Physical functioning	0.6	—
Role-physical	1.4	—
Bodily pain	0.6	—
General health	3.3	—
Mental component summary (MCS)	1.2	—
Social functioning	1.3	—
Role-emotional	1.3	—
Vitality	1.2	—
Mental health	0.9	—
Semaglutide 1.0 mgPhysical component summary (PCS)	1.1	—
Physical functioning	0.9	—
Role-physical	0.2	—
Bodily pain	0.4	—
General health	2.9	—
Mental component summary (MCS)	0.5	—
Social functioning	-0.4	—
Role-emotional	0.9	—
Vitality	1.4	—
Mental health	0.4	—
SitagliptinPhysical component summary (PCS)	0.0	—
Physical functioning	-0.3	—
Role-physical	-0.0	—
Bodily pain	0.0	—
General health	2.2	—
Mental component summary (MCS)	1.5	—
Social functioning	0.8	—
Role-emotional	1.0	—
Vitality	1.1	—
Mental health	1.1	—

Secondary/registry result

Change in Patient Reported Outcome Questionnaire: DTSQs Score

Time frame:Week 0, week 30

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 0.5 mg1) Feeling of unacceptably high blood sugars	-1.4	—
2) Feeling of unacceptably low blood sugars	-0.1	—
3) Satisfaction with treatment	1.1	—
4) Convenience of treatment	0.7	—
5) Flexibility of current treatment	0.7	—
6) Satisfaction with understanding of diabetes	0.9	—
7) Recommending treatment to others	0.9	—
8) Satisfaction to continue with present treatment	0.7	—
Total Diabetic Treatment Satisfaction score	4.9	—
Semaglutide 1.0 mg1) Feeling of unacceptably high blood sugars	-1.6	—
2) Feeling of unacceptably low blood sugars	-0.3	—
3) Satisfaction with treatment	1.3	—
4) Convenience of treatment	0.7	—
5) Flexibility of current treatment	0.8	—
6) Satisfaction with understanding of diabetes	0.8	—
7) Recommending treatment to others	0.9	—
8) Satisfaction to continue with present treatment	0.7	—
Total Diabetic Treatment Satisfaction score	5.1	—
Sitagliptin1) Feeling of unacceptably high blood sugars	-1.0	—
2) Feeling of unacceptably low blood sugars	-0.1	—
3) Satisfaction with treatment	0.7	—
4) Convenience of treatment	0.5	—
5) Flexibility of current treatment	0.4	—
6) Satisfaction with understanding of diabetes	0.7	—
7) Recommending treatment to others	0.7	—
8) Satisfaction to continue with present treatment	0.6	—
Total Diabetic Treatment Satisfaction score	3.7	—

Secondary/protocol endpoint

Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score

Time frame:Week 0, week 30

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in Patient Reported Outcome Questionnaire: DTSQs Score

Time frame:Week 0, week 30

change from baseline, improvement

Safety / tolerability / PK

68 endpoints

Secondary/registry result

Total Number of Treatment Emergent Adverse Events

Time frame:Week 0 to week 30

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 0.5 mg	729	—
Semaglutide 1.0 mg	788	—
Sitagliptin	596	—

Secondary/registry result

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0 to week 30

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide 0.5 mg	3	—
Semaglutide 1.0 mg	7	—
Sitagliptin	5	—

Secondary/registry result

Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0 to week 30

Documented hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mg	2	—
Semaglutide 1.0 mg	6	—
Sitagliptin	4	—

Secondary/registry result

Change in Haematological Parameter: Haemoglobin - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of haemoglobin	95% CI
Semaglutide 0.5 mg	1.00	—
Semaglutide 1.0 mg	1.00	—
Sitagliptin	1.00	—

Secondary/registry result

Change in Haematological Parameter: Haematocrit - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of haematocrit	95% CI
Semaglutide 0.5 mg	1.00	—
Semaglutide 1.0 mg	1.00	—
Sitagliptin	1.00	—

Secondary/registry result

Change in Hematological Parameter: Thrombocytes - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of thrombocytes	95% CI
Semaglutide 0.5 mg	1.01	—
Semaglutide 1.0 mg	1.01	—
Sitagliptin	0.99	—

Secondary/registry result

Change in Hematological Parameter: Erythrocytes - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of erythrocytes	95% CI
Semaglutide 0.5 mg	0.99	—
Semaglutide 1.0 mg	0.99	—
Sitagliptin	0.99	—

Secondary/registry result

Change in Hematological Parameter: Leukocytes - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of leukocytes	95% CI
Semaglutide 0.5 mg	1.03	—
Semaglutide 1.0 mg	1.01	—
Sitagliptin	1.08	—

Secondary/registry result

Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of basophils	95% CI
Semaglutide 0.5 mg	0.91	—
Semaglutide 1.0 mg	0.80	—
Sitagliptin	0.83	—

Secondary/registry result

Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of neutrophils	95% CI
Semaglutide 0.5 mg	1.01	—
Semaglutide 1.0 mg	1.02	—
Sitagliptin	1.02	—

Secondary/registry result

Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of eosinophils	95% CI
Semaglutide 0.5 mg	0.98	—
Semaglutide 1.0 mg	1.04	—
Sitagliptin	1.00	—

Secondary/registry result

Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of monocytes	95% CI
Semaglutide 0.5 mg	0.96	—
Semaglutide 1.0 mg	0.98	—
Sitagliptin	1.04	—

Secondary/registry result

Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lymphocytes	95% CI
Semaglutide 0.5 mg	1.01	—
Semaglutide 1.0 mg	0.98	—
Sitagliptin	0.97	—

Secondary/registry result

Change in Biochemistry Parameter: Amylase - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of amylase	95% CI
Semaglutide 0.5 mg	1.17	—
Semaglutide 1.0 mg	1.19	—
Sitagliptin	1.10	—

Secondary/registry result

Change in Biochemistry Parameter: Lipase - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lipase	95% CI
Semaglutide 0.5 mg	1.33	—
Semaglutide 1.0 mg	1.42	—
Sitagliptin	1.24	—

Secondary/registry result

Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of total bilirubin	95% CI
Semaglutide 0.5 mg	0.93	—
Semaglutide 1.0 mg	0.93	—
Sitagliptin	0.93	—

Secondary/registry result

Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcium	95% CI
Semaglutide 0.5 mg	1.01	—
Semaglutide 1.0 mg	1.01	—
Sitagliptin	1.01	—

Secondary/registry result

Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of total calcium	95% CI
Semaglutide 0.5 mg	1.02	—
Semaglutide 1.0 mg	1.01	—
Sitagliptin	1.01	—

Secondary/registry result

Change in Biochemistry Parameter: Potassium - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of potassium	95% CI
Semaglutide 0.5 mg	1.01	—
Semaglutide 1.0 mg	1.00	—
Sitagliptin	1.00	—

Secondary/registry result

Change in Biochemistry Parameter: Sodium - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of sodium	95% CI
Semaglutide 0.5 mg	1.01	—
Semaglutide 1.0 mg	1.00	—
Sitagliptin	1.00	—

Secondary/registry result

Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of creatine kinase	95% CI
Semaglutide 0.5 mg	1.02	—
Semaglutide 1.0 mg	0.96	—
Sitagliptin	1.07	—

Secondary/registry result

Change in Biochemistry Parameter: Total Protein- Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of total protein	95% CI
Semaglutide 0.5 mg	1.01	—
Semaglutide 1.0 mg	1.00	—
Sitagliptin	1.01	—

Secondary/registry result

Change in Calcitonin - Ratio to Baseline

Time frame:Week -2, week 30

Thyroid event

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcitonin	95% CI
Semaglutide 0.5 mg	0.96	—
Semaglutide 1.0 mg	1.00	—
Sitagliptin	0.96	—

Secondary/registry result

Change in Urinalysis Parameter: Glucose

Time frame:Week 0, week 30

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgAt week 0	189	—
At week 0	28	—
At week 0	12	—
At week 0	20	—
At week 0	37	—
At week 30	244	—
At week 30	7	—
At week 30	10	—
At week 30	11	—
At week 30	14	—
Semaglutide 1.0 mgAt week 0	187	—
At week 0	27	—
At week 0	20	—
At week 0	25	—
At week 0	30	—
At week 30	258	—
At week 30	15	—
At week 30	5	—
At week 30	4	—
At week 30	7	—
SitagliptinAt week 0	176	—
At week 0	42	—
At week 0	25	—
At week 0	21	—
At week 0	23	—
At week 30	233	—
At week 30	23	—
At week 30	5	—
At week 30	12	—
At week 30	14	—

Secondary/registry result

Change in Urinalysis Parameter: pH

Time frame:Week 0, week 30

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgAt week 0	0	—
At week 0	17	—
At week 0	220	—
At week 0	31	—
At week 0	13	—
At week 0	3	—
At week 0	0	—
At week 0	1	—
At week 0	1	—
At week 30	0	—
At week 30	16	—
At week 30	209	—
At week 30	33	—
At week 30	24	—
At week 30	2	—
At week 30	1	—
At week 30	1	—
At week 30	0	—
Semaglutide 1.0 mgAt week 0	0	—
At week 0	15	—
At week 0	214	—
At week 0	40	—
At week 0	14	—
At week 0	4	—
At week 0	2	—
At week 0	0	—
At week 0	0	—
At week 30	0	—
At week 30	21	—
At week 30	194	—
At week 30	40	—
At week 30	30	—
At week 30	3	—
At week 30	1	—
At week 30	0	—
At week 30	0	—
SitagliptinAt week 0	0	—
At week 0	14	—
At week 0	222	—
At week 0	33	—
At week 0	15	—
At week 0	1	—
At week 0	1	—
At week 0	1	—
At week 0	0	—
At week 30	0	—
At week 30	30	—
At week 30	201	—
At week 30	24	—
At week 30	22	—
At week 30	5	—
At week 30	5	—
At week 30	0	—
At week 30	0	—

Secondary/registry result

Change in Urinalysis Parameter: Protein

Time frame:Week 0, week 30

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgAt week 0	231	—
At week 0	31	—
At week 0	17	—
At week 0	6	—
At week 0	0	—
At week 0	1	—
At week 30	247	—
At week 30	22	—
At week 30	13	—
At week 30	4	—
At week 30	0	—
At week 30	0	—
Semaglutide 1.0 mgAt week 0	233	—
At week 0	32	—
At week 0	18	—
At week 0	4	—
At week 0	0	—
At week 0	2	—
At week 30	248	—
At week 30	28	—
At week 30	9	—
At week 30	4	—
At week 30	0	—
At week 30	0	—
SitagliptinAt week 0	235	—
At week 0	30	—
At week 0	15	—
At week 0	6	—
At week 0	0	—
At week 0	1	—
At week 30	239	—
At week 30	24	—
At week 30	12	—
At week 30	11	—
At week 30	0	—
At week 30	1	—

Secondary/registry result

Change in Urinalysis Parameter: Ketones

Time frame:Week 0, week 30

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgAt week 0	267	—
At week 0	11	—
At week 0	8	—
At week 0	0	—
At week 0	0	—
At week 0	0	—
At week 30	268	—
At week 30	12	—
At week 30	6	—
At week 30	0	—
At week 30	0	—
At week 30	0	—
Semaglutide 1.0 mgAt week 0	268	—
At week 0	17	—
At week 0	3	—
At week 0	1	—
At week 0	0	—
At week 0	0	—
At week 30	274	—
At week 30	12	—
At week 30	3	—
At week 30	0	—
At week 30	0	—
At week 30	0	—
SitagliptinAt week 0	274	—
At week 0	9	—
At week 0	3	—
At week 0	0	—
At week 0	1	—
At week 0	0	—
At week 30	274	—
At week 30	11	—
At week 30	1	—
At week 30	1	—
At week 30	0	—
At week 30	0	—

Secondary/registry result

Change in Urinalysis Parameter: Erythrocytes

Time frame:Week 0, week 30

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgAt week 0	251	—
At week 0	25	—
At week 0	5	—
At week 0	1	—
At week 0	4	—
At week 30	258	—
At week 30	18	—
At week 30	4	—
At week 30	2	—
At week 30	4	—
Semaglutide 1.0 mgAt week 0	250	—
At week 0	20	—
At week 0	8	—
At week 0	3	—
At week 0	8	—
At week 30	259	—
At week 30	13	—
At week 30	5	—
At week 30	6	—
At week 30	6	—
SitagliptinAt week 0	253	—
At week 0	19	—
At week 0	9	—
At week 0	3	—
At week 0	3	—
At week 30	252	—
At week 30	22	—
At week 30	9	—
At week 30	1	—
At week 30	3	—

Secondary/registry result

Change in Clinical Evaluation: ECG

Time frame:Week 0, week 30

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgAt week 0	191	—
At week 0	72	—
At week 0	23	—
At week 30	162	—
At week 30	81	—
At week 30	19	—
Semaglutide 1.0 mgAt week 0	196	—
At week 0	68	—
At week 0	26	—
At week 30	172	—
At week 30	74	—
At week 30	18	—
SitagliptinAt week 0	185	—
At week 0	76	—
At week 0	29	—
At week 30	167	—
At week 30	85	—
At week 30	26	—

Secondary/registry result

Change in Clinical Evaluation: Eye Examinations

Time frame:Week 0, week 30

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgAt week 0, Left eye	202	—
At week 0, Left eye	40	—
At week 0, Left eye	44	—
At week 30, Left eye	162	—
At week 30, Left eye	26	—
At week 30, Left eye	42	—
At week 0, Right eye	210	—
At week 0, Right eye	37	—
At week 0, Right eye	39	—
At week 52, Right eye	161	—
At week 52, Right eye	27	—
At week 52, Right eye	42	—
Semaglutide 1.0 mgAt week 0, Left eye	222	—
At week 0, Left eye	32	—
At week 0, Left eye	36	—
At week 30, Left eye	184	—
At week 30, Left eye	18	—
At week 30, Left eye	31	—
At week 0, Right eye	222	—
At week 0, Right eye	31	—
At week 0, Right eye	37	—
At week 52, Right eye	180	—
At week 52, Right eye	19	—
At week 52, Right eye	34	—
SitagliptinAt week 0, Left eye	202	—
At week 0, Left eye	47	—
At week 0, Left eye	41	—
At week 30, Left eye	174	—
At week 30, Left eye	32	—
At week 30, Left eye	41	—
At week 0, Right eye	201	—
At week 0, Right eye	47	—
At week 0, Right eye	42	—
At week 52, Right eye	172	—
At week 52, Right eye	31	—
At week 52, Right eye	43	—

Secondary/registry result

Change in Physical Examination

Time frame:Week -2, week 30

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgAt week -2, General Appearance	282	—
At week -2, General Appearance	3	—
At week -2, General Appearance	2	—
At week 30, General Appearance	252	—
At week 30, General Appearance	3	—
At week 30, General Appearance	1	—
At week -2, Nervous System	277	—
At week -2, Nervous System	5	—
At week -2, Nervous System	5	—
At week 30, Nervous System	247	—
At week 30, Nervous System	4	—
At week 30, Nervous System	5	—
At week -2, Cardiovascular System	276	—
At week -2, Cardiovascular System	9	—
At week -2, Cardiovascular System	2	—
At week 30, Cardiovascular System	245	—
At week 30, Cardiovascular System	8	—
At week 30, Cardiovascular System	3	—
At week -2, Gastrointestinal System	280	—
At week -2, Gastrointestinal System	6	—
At week -2, Gastrointestinal System	1	—
At week 30, Gastrointestinal System	251	—
At week 30, Gastrointestinal System	5	—
At week 30, Gastrointestinal System	0	—
At week -2, Musculoskeletal System	281	—
At week -2, Musculoskeletal System	6	—
At week -2, Musculoskeletal System	0	—
At week 30, Musculoskeletal System	252	—
At week 30, Musculoskeletal System	3	—
At week 30, Musculoskeletal System	1	—
At week -2, Skin	253	—
At week -2, Skin	28	—
At week -2, Skin	6	—
At week 30, Skin	226	—
At week 30, Skin	25	—
At week 30, Skin	5	—
At week -2, Head,Ears,Eyes,Nose, Throat, Neck	273	—
At week -2, Head,Ears,Eyes,Nose, Throat, Neck	12	—
At week -2, Head,Ears,Eyes,Nose, Throat, Neck	2	—
At week 30, Head,Ears,Eyes,Nose, Throat, Neck	245	—
At week 30, Head,Ears,Eyes,Nose, Throat, Neck	9	—
At week 30, Head,Ears,Eyes,Nose, Throat, Neck	2	—
At week -2, Respiratory System	287	—
At week -2, Respiratory System	0	—
At week -2, Respiratory System	0	—
At week 30, Respiratory System	255	—
At week 30, Respiratory System	1	—
At week 30, Respiratory System	0	—
At week -2, Lymph Node Palpation	284	—
At week -2, Lymph Node Palpation	2	—
At week -2, Lymph Node Palpation	1	—
At week 30, Lymph Node Palpation	255	—
At week 30, Lymph Node Palpation	1	—
At week 30, Lymph Node Palpation	0	—
At week -2, Thyroid Gland	280	—
At week -2, Thyroid Gland	6	—
At week -2, Thyroid Gland	1	—
At week 30, Thyroid Gland	253	—
At week 30, Thyroid Gland	2	—
At week 30, Thyroid Gland	1	—
Semaglutide 1.0 mgAt week -2, General Appearance	283	—
At week -2, General Appearance	7	—
At week -2, General Appearance	0	—
At week 30, General Appearance	250	—
At week 30, General Appearance	3	—
At week 30, General Appearance	0	—
At week -2, Nervous System	287	—
At week -2, Nervous System	1	—
At week -2, Nervous System	2	—
At week 30, Nervous System	250	—
At week 30, Nervous System	1	—
At week 30, Nervous System	2	—
At week -2, Cardiovascular System	281	—
At week -2, Cardiovascular System	6	—
At week -2, Cardiovascular System	3	—
At week 30, Cardiovascular System	246	—
At week 30, Cardiovascular System	4	—
At week 30, Cardiovascular System	3	—
At week -2, Gastrointestinal System	285	—
At week -2, Gastrointestinal System	5	—
At week -2, Gastrointestinal System	0	—
At week 30, Gastrointestinal System	250	—
At week 30, Gastrointestinal System	2	—
At week 30, Gastrointestinal System	1	—
At week -2, Musculoskeletal System	283	—
At week -2, Musculoskeletal System	5	—
At week -2, Musculoskeletal System	2	—
At week 30, Musculoskeletal System	247	—
At week 30, Musculoskeletal System	4	—
At week 30, Musculoskeletal System	2	—
At week -2, Skin	252	—
At week -2, Skin	37	—
At week -2, Skin	1	—
At week 30, Skin	217	—
At week 30, Skin	33	—
At week 30, Skin	3	—
At week -2, Head,Ears,Eyes,Nose, Throat, Neck	281	—
At week -2, Head,Ears,Eyes,Nose, Throat, Neck	7	—
At week -2, Head,Ears,Eyes,Nose, Throat, Neck	2	—
At week 30, Head,Ears,Eyes,Nose, Throat, Neck	244	—
At week 30, Head,Ears,Eyes,Nose, Throat, Neck	7	—
At week 30, Head,Ears,Eyes,Nose, Throat, Neck	2	—
At week -2, Respiratory System	288	—
At week -2, Respiratory System	1	—
At week -2, Respiratory System	1	—
At week 30, Respiratory System	250	—
At week 30, Respiratory System	2	—
At week 30, Respiratory System	1	—
At week -2, Lymph Node Palpation	284	—
At week -2, Lymph Node Palpation	5	—
At week -2, Lymph Node Palpation	1	—
At week 30, Lymph Node Palpation	250	—
At week 30, Lymph Node Palpation	3	—
At week 30, Lymph Node Palpation	0	—
At week -2, Thyroid Gland	285	—
At week -2, Thyroid Gland	3	—
At week -2, Thyroid Gland	2	—
At week 30, Thyroid Gland	249	—
At week 30, Thyroid Gland	2	—
At week 30, Thyroid Gland	2	—
SitagliptinAt week -2, General Appearance	281	—
At week -2, General Appearance	8	—
At week -2, General Appearance	1	—
At week 30, General Appearance	270	—
At week 30, General Appearance	5	—
At week 30, General Appearance	1	—
At week -2, Nervous System	279	—
At week -2, Nervous System	8	—
At week -2, Nervous System	3	—
At week 30, Nervous System	268	—
At week 30, Nervous System	5	—
At week 30, Nervous System	3	—
At week -2, Cardiovascular System	278	—
At week -2, Cardiovascular System	10	—
At week -2, Cardiovascular System	2	—
At week 30, Cardiovascular System	265	—
At week 30, Cardiovascular System	10	—
At week 30, Cardiovascular System	1	—
At week -2, Gastrointestinal System	280	—
At week -2, Gastrointestinal System	10	—
At week -2, Gastrointestinal System	0	—
At week 30, Gastrointestinal System	264	—
At week 30, Gastrointestinal System	11	—
At week 30, Gastrointestinal System	1	—
At week -2, Musculoskeletal System	282	—
At week -2, Musculoskeletal System	6	—
At week -2, Musculoskeletal System	2	—
At week 30, Musculoskeletal System	270	—
At week 30, Musculoskeletal System	3	—
At week 30, Musculoskeletal System	3	—
At week -2, Skin	254	—
At week -2, Skin	29	—
At week -2, Skin	7	—
At week 30, Skin	240	—
At week 30, Skin	31	—
At week 30, Skin	5	—
At week -2, Head,Ears,Eyes,Nose, Throat, Neck	277	—
At week -2, Head,Ears,Eyes,Nose, Throat, Neck	7	—
At week -2, Head,Ears,Eyes,Nose, Throat, Neck	6	—
At week 30, Head,Ears,Eyes,Nose, Throat, Neck	263	—
At week 30, Head,Ears,Eyes,Nose, Throat, Neck	8	—
At week 30, Head,Ears,Eyes,Nose, Throat, Neck	5	—
At week -2, Respiratory System	287	—
At week -2, Respiratory System	2	—
At week -2, Respiratory System	1	—
At week 30, Respiratory System	274	—
At week 30, Respiratory System	2	—
At week 30, Respiratory System	0	—
At week -2, Lymph Node Palpation	285	—
At week -2, Lymph Node Palpation	4	—
At week -2, Lymph Node Palpation	1	—
At week 30, Lymph Node Palpation	271	—
At week 30, Lymph Node Palpation	5	—
At week 30, Lymph Node Palpation	0	—
At week -2, Thyroid Gland	281	—
At week -2, Thyroid Gland	9	—
At week -2, Thyroid Gland	0	—
At week 30, Thyroid Gland	270	—
At week 30, Thyroid Gland	5	—
At week 30, Thyroid Gland	1	—

Secondary/registry result

Anti-semaglutide Antibody Levels

Time frame:week 30, week 35

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (mean), %B/T	95% CI
Semaglutide 1.0 mgAt week 30	2.8	—
At week 35	3.3	—

Secondary/registry result

Occurence of Anti-semaglutide Antibodies (Yes/no)

Time frame:Week 0, week 16, week 30, week 35

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgAt week 0	0	—
At week 0	285	—
At week 16	1	—
At week 16	284	—
At week 30	0	—
At week 30	257	—
At week 35	0	—
At week 35	262	—
Semaglutide 1.0 mgAt week 0	1	—
At week 0	288	—
At week 16	0	—
At week 16	290	—
At week 30	2	—
At week 30	261	—
At week 35	3	—
At week 35	261	—

Secondary/registry result

Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)

Time frame:Week 0, week 16, week 30, week 35

Immunogenicity (ADA)

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgAt week 0	0	—
At week 0	285	—
At week 16	0	—
At week 16	285	—
At week 30	0	—
At week 30	257	—
At week 35	0	—
At week 35	262	—
Semaglutide 1.0 mgAt week 0	0	—
At week 0	289	—
At week 16	0	—
At week 16	290	—
At week 30	0	—
At week 30	263	—
At week 35	0	—
At week 35	264	—

Secondary/registry result

Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no)

Time frame:Week 35

Immunogenicity (ADA)

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgYes (positive for antibody)	0	—
No (negative for antibody)	262	—
Semaglutide 1.0 mgYes (positive for antibody)	1	—
No (negative for antibody)	263	—

Secondary/registry result

Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no)

Time frame:Week 35

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.5 mgYes (positive for antibody)	0	—
No (negative for antibody)	262	—
Semaglutide 1.0 mgYes (positive for antibody)	0	—
No (negative for antibody)	264	—

Secondary/protocol endpoint

Total Number of Treatment Emergent Adverse Events

Time frame:Week 0 to week 30

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0 to week 30

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0 to week 30

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Change in Haematological Parameter: Haemoglobin - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter: Haematocrit - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Hematological Parameter: Thrombocytes - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Hematological Parameter: Erythrocytes - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Hematological Parameter: Leukocytes - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter: Amylase - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter: Lipase - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter: Potassium - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter: Sodium - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint/low confidence

Change in Biochemistry Parameter: Total Protein- Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint

Change in Calcitonin - Ratio to Baseline

Time frame:Week -2, week 30

Thyroid event

ratio, descriptive

Secondary/protocol endpoint

Change in Urinalysis Parameter: pH

Time frame:Week 0, week 30

categorical status, descriptive

Secondary/protocol endpoint

Change in Urinalysis Parameter: Ketones

Time frame:Week 0, week 30

categorical status, descriptive

Secondary/protocol endpoint

Change in Clinical Evaluation: ECG

Time frame:Week 0, week 30

categorical status, descriptive

Secondary/protocol endpoint

Change in Clinical Evaluation: Eye Examinations

Time frame:Week 0, week 30

categorical status, event

Secondary/protocol endpoint

Change in Physical Examination

Time frame:Week -2, week 30

categorical status, descriptive

Secondary/protocol endpoint

Anti-semaglutide Antibody Levels

Time frame:week 30, week 35

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Occurence of Anti-semaglutide Antibodies (Yes/no)

Time frame:Week 0, week 16, week 30, week 35

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)

Time frame:Week 0, week 16, week 30, week 35

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no)

Time frame:Week 35

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no)

Time frame:Week 35

Immunogenicity (ADA)

categorical status, event

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Change in Fasting Glucagon - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Secondary/protocol endpoint/low confidence

Change in Biochemistry Parameter: Albumin - Ratio to Baseline

Time frame:Week 0, week 30

ratio, descriptive

Secondary/protocol endpoint/low confidence

Change in Biochemistry Parameter: Urea - Ratio to Baseline

Time frame:Week 0, week 30

ratio, improvement

Publications (2)

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

Efficacy and Safety of Once-Weekly Semaglutide Versus Once-Daily Sitagliptin as Metformin Add-on in a Korean Population with Type 2 Diabetes.
Diabetes therapy : research, treatment and education of diabetes and related disorders2024 Feb (month)PMID38236431doi:10.1007/s13300-023-01515-0via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes in SUSTAIN China: A 30-week, double-blind, phase 3a, randomized trial.
Diabetes, obesity & metabolism2021 Feb (month)PMID33074557doi:10.1111/dom.14232via CT.gov reference

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.