SUSTAIN 11

CompletedPhase 3Results posted

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

210

Recruiting sites

—

Enrollment

2,274

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥7.5%

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 IDNCT03689374

Org study IDNN9535-4386

Secondary ID2017-003219-20EudraCT

Secondary IDU1111-1200-0164World Health Organization (WHO)

Timeline

Milestones

Study first posted2018-09-28actual

Study start2018-10-01actual

Primary completion2021-02-22actual

Study completion2021-02-22actual

Results first posted2022-05-04actual

Last update posted2022-11-14actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age greater than or equal to 18 years at the time of signing informed consent

•Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening

•Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening

•Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors

•Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)

Exclusion criteria

•History or presence of pancreatitis (acute or chronic)

•Any of the following: myocardial infarction, stroke, hospitalization 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 Class IV

•Planned coronary, carotid or peripheral artery revascularisation known on the day of screening

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in

Endpoints (50)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

Patient-reported / QoL

Other (unclassified)

Weight & body composition

8 endpoints

Secondary/registry result

Change From Baseline to Week 52 in Body Weight (Kilogram (kg))

Time frame:Baseline (week 0), week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilograms	95% CI
Semaglutide	-4.2	—
Insulin Aspart	2.9	—

Secondary/registry result

Change From Baseline to Week 52 in Body Mass Index (BMI)

Time frame:Baseline (week 0), week 52

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kilograms per meter square (kg/m^2)	95% CI
Semaglutide	-1.5	—
Insulin Aspart	1.0	—

Secondary/registry result

Change From Baseline to Week 52 in Waist Circumference

Time frame:Baseline (week 0), week 52

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeters (cm)	95% CI
Semaglutide	-3.3	—
Insulin Aspart	2.1	—

Secondary/registry result

Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline

Time frame:Baseline (week 0), week 52

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Ratio of body weight	95% CI
Semaglutide	1.0	—
Insulin Aspart	1.0	—

Secondary/protocol endpoint

Change From Baseline to Week 52 in Body Weight (Kilogram (kg))

Time frame:Baseline (week 0), week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 52 in Body Mass Index (BMI)

Time frame:Baseline (week 0), week 52

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 52 in Waist Circumference

Time frame:Baseline (week 0), week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline

Time frame:Baseline (week 0), week 52

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

11 endpoints

Primary/registry result

Change From Baseline in Glycated Haemoglobin (HbA1c)

Time frame:Baseline (week 0), week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Semaglutide	-1.5	—
Insulin Aspart	-1.2	—

Treatment difference-0.2995% CI-0.38 – -0.20p<0.0001t-distributed test

Primary/protocol endpoint

Change From Baseline in Glycated Haemoglobin (HbA1c)

Time frame:Baseline (week 0), week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result/low confidence

Daily Basal Insulin Dose at Week 52

Time frame:At week 52

descriptive

Posted result

Group	Value (mean), Units of insulin	95% CI
Semaglutide	35.8	—
Insulin Aspart	40.7	—

Secondary/registry result

Total Daily Insulin Dose at Week 52

Time frame:At week 52

descriptive

Posted result

Group	Value (mean), Units of insulin	95% CI
Semaglutide	35.8	—
Insulin Aspart	77.7	—

Secondary/registry result

Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)

Time frame:Baseline (week 0), week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), millimoles per liter (mmol/L)	95% CI
Semaglutide	-1.3	—
Insulin Aspart	-0.8	—

Secondary/registry result

Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)

Time frame:Baseline (week 0), week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide	-2.1	—
Insulin Aspart	-2.1	—

Secondary/registry result

Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)

Time frame:Baseline (week 0), week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide	-0.7	—
Insulin Aspart	-0.9	—

Secondary/protocol endpoint

Daily Basal Insulin Dose at Week 52

Time frame:At week 52

descriptive

Secondary/protocol endpoint

Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)

Time frame:Baseline (week 0), week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)

Time frame:Baseline (week 0), week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)

Time frame:Baseline (week 0), week 52

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

12 endpoints

Secondary/registry result

Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)

Time frame:Baseline (week 0), week 52

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Semaglutide	1.0	—
Insulin Aspart	1.0	—

Secondary/registry result

Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Time frame:Baseline (week 0), week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Semaglutide	1.0	—
Insulin Aspart	1.0	—

Secondary/registry result

Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Time frame:Baseline (week 0), week 52

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL cholesterol	95% CI
Semaglutide	1.0	—
Insulin Aspart	1.0	—

Secondary/registry result

Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)

Time frame:Baseline (week 0), week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Semaglutide	0.9	—
Insulin Aspart	1.0	—

Secondary/registry result

Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure

Time frame:Baseline (week 0), week 52

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), millimeter of mercury (mmHg)	95% CI
SemaglutideDiastolic Blood Pressure	-1.4	—
Systolic Blood Pressure	-2.8	—
Insulin AspartDiastolic Blood Pressure	-0.4	—
Systolic Blood Pressure	1.0	—

Secondary/registry result

Change From Baseline to Week 52 in Pulse Rate

Time frame:Baseline (week 0), week 52

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute (beats/min)	95% CI
Semaglutide	2.2	—
Insulin Aspart	1.1	—

Secondary/protocol endpoint

Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)

Time frame:Baseline (week 0), week 52

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Time frame:Baseline (week 0), week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Time frame:Baseline (week 0), week 52

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)

Time frame:Baseline (week 0), week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure

Time frame:Baseline (week 0), week 52

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

Change From Baseline to Week 52 in Pulse Rate

Time frame:Baseline (week 0), week 52

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains

Time frame:Baseline (week 0), week 52

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
SemaglutidePhysical Component Summary	1.4	—
Mental Component Summary	0.1	—
Physical Functioning	1.4	—
Role Physical Health	0.1	—
Bodily Pain	1.5	—
General Health	1.6	—
Vitality	1.1	—
Social Functioning	0.2	—
Role Emotional Problem	0.0	—
Mental Health	0.6	—
Insulin AspartPhysical Component Summary	0.4	—
Mental Component Summary	-0.3	—
Physical Functioning	0.2	—
Role Physical Health	-0.2	—
Bodily Pain	0.8	—
General Health	0.3	—
Vitality	0.1	—
Social Functioning	-0.6	—
Role Emotional Problem	-0.2	—
Mental Health	0.1	—

Secondary/registry result

Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains

Time frame:Baseline (week 0), week 52

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
SemaglutidePhysical function	2.4	—
Energy or fatigue	2.3	—
Health distress	-0.2	—
Mental health	7.2	—
Satisfaction	4.1	—
Treatment satisfaction	9.9	—
Treatment flexibility	4.2	—
Frequency of symptoms	4.1	—
Insulin AspartPhysical function	-0.4	—
Energy or fatigue	0.4	—
Health distress	0.3	—
Mental health	0.5	—
Satisfaction	-0.2	—
Treatment satisfaction	0.8	—
Treatment flexibility	-1.2	—
Frequency of symptoms	1.8	—

Secondary/protocol endpoint

Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains

Time frame:Baseline (week 0), week 52

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains

Time frame:Baseline (week 0), week 52

change from baseline, improvement

Safety / tolerability / PK

14 endpoints

Secondary/registry result

Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52

Time frame:From randomization (week 0) up to week 52

Severe hypoglycemia

time to event, event

Posted result

Group	Value (number), First event per 100 years of exposure	95% CI
Semaglutide	0.4	—
Insulin Aspart	0.7	—

Secondary/registry result

Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52

Time frame:From randomization (week 0) up to week 52

Severe hypoglycemia

time to event, event

Posted result

Group	Value (number), First event per 100 years of exposure	95% CI
Semaglutide	0.2	—
Insulin Aspart	0.4	—

Secondary/registry result

Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52

Time frame:From randomization (week 0) to week 52

Severe hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide	4	—
Insulin Aspart	7	—

Secondary/registry result

Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52

Time frame:From randomization (week 0) to week 52

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide	254	—
Insulin Aspart	1744	—

Secondary/registry result

Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52

Time frame:From randomization (week 0) to week 52

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide	1420	—
Insulin Aspart	5616	—

Secondary/registry result

Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52

Time frame:From randomization (week 0) to week 52

Severe hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide	2	—
Insulin Aspart	4	—

Secondary/registry result

Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52

Time frame:From randomization (week 0) to week 52

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide	339	—
Insulin Aspart	2270	—

Secondary/protocol endpoint

Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52

Time frame:From randomization (week 0) up to week 52

Severe hypoglycemia

time to event, event

Secondary/protocol endpoint

Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52

Time frame:From randomization (week 0) up to week 52

Severe hypoglycemia

time to event, event

Secondary/protocol endpoint

Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52

Time frame:From randomization (week 0) to week 52

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Time frame:From randomization (week 0) to week 52

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52

Time frame:From randomization (week 0) to week 52

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52

Time frame:From randomization (week 0) to week 52

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52

Time frame:From randomization (week 0) to week 52

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Total Daily Insulin Dose at Week 52

Time frame:At week 52

descriptive

Publications (1)

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

Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial.
Diabetes, obesity & metabolism2022 Sep (month)PMID35546450doi:10.1111/dom.14765via 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.