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.

Frías JP, Auerbach P, Bajaj HS, Fukushima Y, Lingvay I, Macura S, Søndergaard AL, Tankova TI, Tentolouris N, Buse JB

The lancet. Diabetes & endocrinology21 Jul 2021Cited by 152 (Europe PMC)

PMID34293304DOI10.1016/s2213-8587(21)00174-1PepBankPUB-34293304

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with inadequately controlled type 2 diabetes, semaglutide 2.0 mg lowered HbA1c more than 1.0 mg at week 40 (trial product estimand).
In plain wordsIn adults with type 2 diabetes, semaglutide 2.0 mg lowered HbA1c more than semaglutide 1.0 mg after 40 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 40 (trial product estimand)
Study
n = 961
Comparator
Semaglutide 1.0 mg once weekly
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.0 mg once weekly · 40 weeksAs given in this study (human).
Measurements
HbA1c change
−2.2 percentage points
semaglutide 2.0 mg
HbA1c change
−1.9 percentage points
semaglutide 1.0 mg
ETD
−0.23 percentage points
2.0 mg vs 1.0 mg
Source sentences
Summary
Mean change in HbA_1c from baseline at week 40 was -2·2 percentage points with semaglutide 2·0 mg and -1·9 percentage points with semaglutide 1·0 mg (estimated treatment difference [ETD] -0·23 percentage points [95% CI -0·36 to -0·11]; p=0·0003; trial product estimand)
2 context sentences(design, population, supporting numbers)
Summary · context
Outcomes included change from baseline at week 40 in HbA_1c (primary outcome) and bodyweight (secondary confirmatory outcome), evaluated through trial product estimand (no treatment discontinuation or without rescue medication) and treatment policy estimand (regardless of treatment discont…
Summary · context
Participants (≥18 years) with inadequately controlled type 2 diabetes (HbA_1c 8·0-10·0%) with metformin and with or without sulfonylurea were randomly assigned (1:1) by an interactive web-response system to 2·0 mg or 1·0 mg once-weekly semaglutide.
Report a problemFND-3429330401
02HumanRandomized controlled trialEfficacy outcome
In adults with inadequately controlled type 2 diabetes, semaglutide 2.0 mg lowered HbA1c more than 1.0 mg at week 40 (treatment policy estimand).
In plain wordsIn adults with type 2 diabetes, semaglutide 2.0 mg lowered HbA1c more than semaglutide 1.0 mg after 40 weeks, whatever the treatment course.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 40 (treatment policy estimand)
Study
n = 961
Comparator
Semaglutide 1.0 mg once weekly
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.0 mg once weekly · 40 weeksAs given in this study (human).
Measurements
HbA1c change
−2.1 percentage points
semaglutide 2.0 mg
HbA1c change
−1.9 percentage points
semaglutide 1.0 mg
ETD
−0.18 percentage points
2.0 mg vs 1.0 mg
Source sentences
Summary
and -2·1 percentage points with semaglutide 2·0 mg and -1·9 percentage points with semaglutide 1·0 mg (ETD -0·18 percentage points [-0·31 to -0·04]; p=0·0098; treatment policy estimand).
2 context sentences(design, population, supporting numbers)
Summary · context
Outcomes included change from baseline at week 40 in HbA_1c (primary outcome) and bodyweight (secondary confirmatory outcome), evaluated through trial product estimand (no treatment discontinuation or without rescue medication) and treatment policy estimand (regardless of treatment discont…
Summary · context
Participants (≥18 years) with inadequately controlled type 2 diabetes (HbA_1c 8·0-10·0%) with metformin and with or without sulfonylurea were randomly assigned (1:1) by an interactive web-response system to 2·0 mg or 1·0 mg once-weekly semaglutide.
Report a problemFND-3429330402
03HumanRandomized controlled trialEfficacy outcome
In adults with inadequately controlled type 2 diabetes, semaglutide 2.0 mg lowered bodyweight more than 1.0 mg at week 40 (trial product estimand).
In plain wordsIn adults with type 2 diabetes, semaglutide 2.0 mg led to more weight loss than semaglutide 1.0 mg after 40 weeks.
Peptide
Semaglutide
Outcome
DecreaseBodyweight change at week 40 (trial product estimand)
Study
n = 961
Comparator
Semaglutide 1.0 mg once weekly
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.0 mg once weekly · 40 weeksAs given in this study (human).
Measurements
Bodyweight change
−6.9 kg
semaglutide 2.0 mg
Bodyweight change
−6 kg
semaglutide 1.0 mg
ETD
−0.93 kg
2.0 mg vs 1.0 mg
Source sentences
Summary
Mean change in bodyweight from baseline at week 40 was -6·9 kg with semaglutide 2·0 mg and -6·0 kg with semaglutide 1·0 mg (ETD -0·93 kg [95% CI -1·68 to -0·18]; p=0·015; trial product estimand)
2 context sentences(design, population, supporting numbers)
Summary · context
Outcomes included change from baseline at week 40 in HbA_1c (primary outcome) and bodyweight (secondary confirmatory outcome), evaluated through trial product estimand (no treatment discontinuation or without rescue medication) and treatment policy estimand (regardless of treatment discont…
Summary · context
Participants (≥18 years) with inadequately controlled type 2 diabetes (HbA_1c 8·0-10·0%) with metformin and with or without sulfonylurea were randomly assigned (1:1) by an interactive web-response system to 2·0 mg or 1·0 mg once-weekly semaglutide.
Report a problemFND-3429330403
04HumanRandomized controlled trialEfficacy outcome
In adults with inadequately controlled type 2 diabetes, the bodyweight difference between semaglutide 2.0 mg and 1.0 mg at week 40 was not significant (treatment policy estimand, p=0.054).
In plain wordsIn adults with type 2 diabetes, weight loss with semaglutide 2.0 mg was not clearly different from 1.0 mg when all patients were counted.
Peptide
Semaglutide
Outcome
No significant changeBodyweight change at week 40 (treatment policy estimand)
Study
n = 961
Comparator
Semaglutide 1.0 mg once weekly
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.0 mg once weekly · 40 weeksAs given in this study (human).
Measurements
Bodyweight change
−6.4 kg
semaglutide 2.0 mg
Bodyweight change
−5.6 kg
semaglutide 1.0 mg
ETD
−0.77 kg
2.0 mg vs 1.0 mg
Source sentences
Summary
and -6·4 kg with semaglutide 2·0 mg and -5·6 kg with semaglutide 1·0 mg (ETD -0·77 kg [-1·55 to 0·01]; p=0·054; treatment policy estimand).
2 context sentences(design, population, supporting numbers)
Summary · context
Outcomes included change from baseline at week 40 in HbA_1c (primary outcome) and bodyweight (secondary confirmatory outcome), evaluated through trial product estimand (no treatment discontinuation or without rescue medication) and treatment policy estimand (regardless of treatment discont…
Summary · context
Participants (≥18 years) with inadequately controlled type 2 diabetes (HbA_1c 8·0-10·0%) with metformin and with or without sulfonylurea were randomly assigned (1:1) by an interactive web-response system to 2·0 mg or 1·0 mg once-weekly semaglutide.
Report a problemFND-3429330404
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, gastrointestinal disorders were the most commonly reported adverse events, in 34% with semaglutide 2.0 mg and 31% with 1.0 mg.
In plain wordsIn adults with type 2 diabetes, gut problems were the most common side effects, in 34% on 2.0 mg and 31% on 1.0 mg.
Peptide
Semaglutide
Outcome
Not applicableGastrointestinal disorders
Study
n = 961
Comparator
Semaglutide 1.0 mg once weekly
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.0 mg once weekly · 40 weeksAs given in this study (human).
Measurements
Gastrointestinal disorders
34%
semaglutide 2.0 mg
Gastrointestinal disorders
31%
semaglutide 1.0 mg
Source sentences
Summary
Gastrointestinal disorders were the most commonly reported adverse events (163 [34%] in the 2·0 mg group and 148 [31%] in the 1·0 mg group).
1 context sentence(design, population, supporting numbers)
Summary · context
Participants (≥18 years) with inadequately controlled type 2 diabetes (HbA_1c 8·0-10·0%) with metformin and with or without sulfonylurea were randomly assigned (1:1) by an interactive web-response system to 2·0 mg or 1·0 mg once-weekly semaglutide.
Report a problemFND-3429330405
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, serious adverse events were similar between semaglutide 2.0 mg (4%) and 1.0 mg (5%).
In plain wordsIn adults with type 2 diabetes, serious side effects were similar on semaglutide 2.0 mg and 1.0 mg.
Peptide
Semaglutide
Outcome
No significant changeSerious adverse events
Study
n = 961
Comparator
Semaglutide 1.0 mg once weekly
Outcome group
Adverse events · Whole body
Studied dose
2.0 mg once weekly · 40 weeksAs given in this study (human).
Measurements
Serious adverse events
4%
semaglutide 2.0 mg
Serious adverse events
5%
semaglutide 1.0 mg
Source sentences
Summary
Serious adverse events were similar between treatment groups, reported for 21 (4%) participants given semaglutide 2·0 mg and 25 (5%) participants given semaglutide 1·0 mg.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants (≥18 years) with inadequately controlled type 2 diabetes (HbA_1c 8·0-10·0%) with metformin and with or without sulfonylurea were randomly assigned (1:1) by an interactive web-response system to 2·0 mg or 1·0 mg once-weekly semaglutide.
Report a problemFND-3429330406
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, three deaths occurred during the trial, two in the semaglutide 2.0 mg group and one in the 1.0 mg group.
In plain wordsIn adults with type 2 diabetes, three deaths occurred during the trial, two on semaglutide 2.0 mg and one on 1.0 mg.
Peptide
Semaglutide
Outcome
Not applicableDeaths
Study
n = 961
Comparator
Semaglutide 1.0 mg once weekly
Outcome group
Mortality · Whole body
Studied dose
2.0 mg once weekly · 40 weeksAs given in this study (human).
Measurements
Deaths
2 participants
semaglutide 2.0 mg
Deaths
1 participants
semaglutide 1.0 mg
Source sentences
Summary
Three deaths were reported during the trial (one in the semaglutide 1·0 mg group and two in the semaglutide 2·0 mg group).
1 context sentence(design, population, supporting numbers)
Summary · context
Participants (≥18 years) with inadequately controlled type 2 diabetes (HbA_1c 8·0-10·0%) with metformin and with or without sulfonylurea were randomly assigned (1:1) by an interactive web-response system to 2·0 mg or 1·0 mg once-weekly semaglutide.
Report a problemFND-3429330407

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03989232

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

Novo Nordisk A/Sn = 96119 Jun 2019 to 9 Nov 2020

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 13 Feb 2023

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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