Phase 3
Completed N=961
A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03989232 ↗Enrolled (actual)
961
Serious AEs
4.8%
Results posted
Oct 2021
Primary outcomePrimary: Change in HbA1c — -2.0; -2.2; -1.9; -2.2 Percentage change — p=0.0003
◆ Published Evidence
Highly cited
169citations · ~34 / year
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.
Summary
This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c |
-2.0; -2.2; -1.9; -2.2 | 0.0003 sig |
| SECONDARY Change in Body Weight |
-6.0; -7.0; -5.7; -6.7 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-3.2; -3.4 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-2.1; -2.5 | — |
| SECONDARY Change in Waist Circumference |
-5.2; -5.9 | — |
| SECONDARY Participants Who Achieved HbA1c < 7.0% |
57.5; 67.6 | — |
| SECONDARY Participants Who Achieved HbA1c ≤ 6.5% |
38.5; 51.7 | — |
| SECONDARY Participants Who Achieved Weight Loss ≥5% |
51.3; 59.2 | — |
| SECONDARY Participants Who Achieved Weight Loss ≥10% |
22.6; 28.4 | — |
| SECONDARY Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes |
28; 21 | — |
| SECONDARY Change in Pulse Rate |
2.8; 3.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03989232) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.