Phase 3 · Semaglutide

SUSTAIN FORTE trial results

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

Participants
961
Status
completed
Completed
2020-11-09
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT03989232), updated at source Feb 13, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SUSTAIN FORTE measured first

Change in HbA1cPercentage change · Week 0, week 40 · mean
MeasureSemaglutide 1.0 mgn=481Semaglutide 2.0 mgn=480
On-treatment without rescue medication-2.0(1.0)-2.2(1.0)
In-trial-1.9(1.0)-2.2(1.1)
Side effects by arm

Side effects in SUSTAIN FORTE

Percent of participants affected, Weeks 0-47. The most common events the registry lists.

EventSemaglutide 1.0 mgSemaglutide 2.0 mg
Any serious event5.2%4.4%
Nausea14.6%14.4%
Diarrhoea8.8%9.4%
Vomiting6.7%7.7%
Decreased appetite3.8%6.1%
Dyspepsia5.2%3.3%
Secondary outcomes

What else it measured

Change in Body WeightKilogram (kg) · Week 0, week 40 · mean
MeasureSemaglutide 1.0 mgn=481Semaglutide 2.0 mgn=480
On-treatment without rescue medication-6.0(5.8)-7.0(5.8)
In-trial-5.7(5.9)-6.7(5.9)
Change in Fasting Plasma Glucose (FPG)Millimoles per liter (mmol/L) · Week 0, week 40 · mean
Semaglutide 1.0 mgn=423Semaglutide 2.0 mgn=429
-3.2(2.8)-3.4(3.1)
Change in Body Mass Index (BMI)Kilogram per squaremeter (Kg/m^2) · Week 0, week 40 · mean
Semaglutide 1.0 mgn=425Semaglutide 2.0 mgn=434
-2.1(2.1)-2.5(2.1)
Change in Waist CircumferenceCentimeter (cm) · Week 0, week 40 · mean
Semaglutide 1.0 mgn=423Semaglutide 2.0 mgn=433
-5.2(6.1)-5.9(6.2)
Participants Who Achieved HbA1c < 7.0%Percentage of participants · Week 40 · number
Semaglutide 1.0 mgn=481Semaglutide 2.0 mgn=480
57.567.6
Participants Who Achieved HbA1c ≤ 6.5%Percentage of participants · Week 40 · number
Semaglutide 1.0 mgn=481Semaglutide 2.0 mgn=480
38.551.7
Participants Who Achieved Weight Loss ≥5%Percentage of participants · Week 40 · number
Semaglutide 1.0 mgn=481Semaglutide 2.0 mgn=480
51.359.2
Participants Who Achieved Weight Loss ≥10%Percentage of participants · Week 40 · number
Semaglutide 1.0 mgn=481Semaglutide 2.0 mgn=480
22.628.4
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic EpisodesEpisodes · Week 0 to week 47 · number
Semaglutide 1.0 mgn=480Semaglutide 2.0 mgn=479
2821
Change in Pulse RateBeats per minute · Week 0, week 40 · mean
Semaglutide 1.0 mgn=444Semaglutide 2.0 mgn=442
2.8(10.0)3.3(9.5)
The trial

How SUSTAIN FORTE was run

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.

  • Semaglutide 2.0 mg: All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each.
  • Semaglutide 1.0 mg: All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.
Who could join the trial

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

Published papers

Papers from SUSTAIN FORTE

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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