SUSTAIN FORTE

CompletedPhase 3Results posted

A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

129

Recruiting sites

—

Enrollment

961

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 8-10%

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 IDNCT03989232

Org study IDNN9535-4506

Secondary ID2018-004529-96European Medicines Agency (EudraCT)

Secondary IDU1111-1224-5162World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-06-18actual

Study start2019-06-19actual

Primary completion2020-09-18actual

Study completion2020-11-09actual

Results first posted2021-10-22actual

Last update posted2023-02-13actual

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 equal to or above18 years at the time of signing informed consent

•Diagnosed with T2D at least 180 days prior to the day of screening

•HbA1c of 8-10% (64-86 mmol/mol) (both inclusive)

•Stable daily dose(s) for 90 days prior to the day of screening of:

•Any metformin formulations (equal to or above1500 mg or maximum tolerated or effective dose) alone or in combination with sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)

Exclusion criteria

•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 insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes

•Renal impairment measured as estimated glomerular filtration rate (eGFR) value of <30 mL/min/1.73 m^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Endpoints (22)

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

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

10 endpoints

Secondary/registry result

Change in Body Weight

Time frame:Week 0, week 40

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (kg)	95% CI
Semaglutide 1.0 mgOn-treatment without rescue medication	-6.0	—
In-trial	-5.7	—
Semaglutide 2.0 mgOn-treatment without rescue medication	-7.0	—
In-trial	-6.7	—

Secondary/registry result

Change in Body Mass Index (BMI)

Time frame:Week 0, week 40

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram per squaremeter (Kg/m^2)	95% CI
Semaglutide 1.0 mg	-2.1	—
Semaglutide 2.0 mg	-2.5	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 40

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeter (cm)	95% CI
Semaglutide 1.0 mg	-5.2	—
Semaglutide 2.0 mg	-5.9	—

Secondary/registry result

Participants Who Achieved Weight Loss ≥5%

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	51.3	—
Semaglutide 2.0 mg	59.2	—

Secondary/registry result

Participants Who Achieved Weight Loss ≥10%

Time frame:Week 40

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	22.6	—
Semaglutide 2.0 mg	28.4	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, week 40

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Week 0, week 40

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, week 40

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieved Weight Loss ≥5%

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Who Achieved Weight Loss ≥10%

Time frame:Week 40

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

8 endpoints

Primary/registry result

Change in HbA1c

Time frame:Week 0, week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage change	95% CI
Semaglutide 1.0 mgOn-treatment without rescue medication	-2.0	—
In-trial	-1.9	—
Semaglutide 2.0 mgOn-treatment without rescue medication	-2.2	—
In-trial	-2.2	—

Treatment difference-0.2395% CI-0.36 – -0.11p0.0003ANCOVA

Treatment difference-0.1895% CI-0.31 – -0.04p0.0098ANCOVA

Primary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Semaglutide 1.0 mg	-3.2	—
Semaglutide 2.0 mg	-3.4	—

Secondary/registry result

Participants Who Achieved HbA1c < 7.0%

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	57.5	—
Semaglutide 2.0 mg	67.6	—

Secondary/registry result

Participants Who Achieved HbA1c ≤ 6.5%

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 1.0 mg	38.5	—
Semaglutide 2.0 mg	51.7	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Participants Who Achieved HbA1c < 7.0%

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c ≤ 6.5%

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints

Secondary/registry result

Change in Pulse Rate

Time frame:Week 0, week 40

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	95% CI
Semaglutide 1.0 mg	2.8	—
Semaglutide 2.0 mg	3.3	—

Secondary/protocol endpoint

Change in Pulse Rate

Time frame:Week 0, week 40

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/registry result

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

Time frame:Week 0 to week 47

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide 1.0 mg	28	—
Semaglutide 2.0 mg	21	—

Secondary/protocol endpoint

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

Time frame:Week 0 to week 47

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

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

Efficacy and safety of once-weekly semaglutide 2·0 mg versus 1·0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial.
The lancet. Diabetes & endocrinology2021 Sep (month)PMID34293304doi:10.1016/S2213-8587(21)00174-1via 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.