Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial.

Sorli C, Harashima SI, Tsoukas GM, Unger J, Karsbøl JD, Hansen T, Bain SC

The lancet. Diabetes & endocrinology17 Jan 2017Cited by 600 (Europe PMC)

PMID28110911DOI10.1016/s2213-8587(17)30013-xPepBankPUB-28110911

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 study12

12 results from studies that gave the peptide. 12 results from people.

01HumanRandomized controlled trialEfficacy outcome
In treatment-naive adults with type 2 diabetes, semaglutide 1·0 mg lowered HbA1c more than placebo at week 30 (difference -1·53%).
In plain wordsIn adults with type 2 diabetes, weekly semaglutide 1·0 mg lowered HbA1c more than placebo after 30 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 30
Study
n = 130
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
significantly decreased by 1·55% (-1·74 to -1·36) with 1·0 mg semaglutide (estimated treatment difference vs placebo -1·53%, -1·81 to -1·25; p<0·0001)
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091102
02HumanRandomized controlled trialEfficacy outcome
In treatment-naive adults with type 2 diabetes, semaglutide 0·5 mg lowered HbA1c more than placebo at week 30 (difference -1·43%).
In plain wordsIn adults with type 2 diabetes, weekly semaglutide 0·5 mg lowered HbA1c more than placebo after 30 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 30
Study
n = 128
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.5 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
at week 30, HbA_1c significantly decreased by 1·45% (95% CI -1·65 to -1·26) with 0·5 mg semaglutide (estimated treatment difference vs placebo -1·43%, 95% CI -1·71 to -1·15; p<0·0001)
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091101
03HumanRandomized controlled trialEfficacy outcome
In treatment-naive adults with type 2 diabetes, semaglutide 1·0 mg reduced bodyweight more than placebo at week 30 (difference -3·56 kg).
In plain wordsIn adults with type 2 diabetes, weekly semaglutide 1·0 mg reduced body weight more than placebo after 30 weeks.
Peptide
Semaglutide
Outcome
DecreaseBodyweight change at week 30
Study
n = 130
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
significantly decreased by 4·53 kg (-5·34 to -3·72) with 1·0 mg semaglutide (estimated treatment difference vs placebo -3·56 kg, -4·74 to -2·38; p<0·0001)
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091104
04HumanRandomized controlled trialEfficacy outcome
In treatment-naive adults with type 2 diabetes, semaglutide 0·5 mg reduced bodyweight more than placebo at week 30 (difference -2·75 kg).
In plain wordsIn adults with type 2 diabetes, weekly semaglutide 0·5 mg reduced body weight more than placebo after 30 weeks.
Peptide
Semaglutide
Outcome
DecreaseBodyweight change at week 30
Study
n = 128
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
0.5 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
at week 30, bodyweight significantly decreased by 3·73 kg (95% CI -4·54 to -2·91) with 0·5 mg semaglutide (estimated treatment difference vs placebo -2·75 kg, 95% CI -3·92 to -1·58; p<0·0001)
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091103
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, no deaths were reported in any study group, including both semaglutide groups.
In plain wordsIn adults with type 2 diabetes, nobody died in any group of the trial.
Peptide
Semaglutide
Outcome
No significant changeDeaths
Study
n = 258
Comparator
Placebo
Outcome group
Mortality · Whole body
Studied dose
0.5 mg and 1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
No deaths were reported in any of the study groups
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091111
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, most reported adverse events were of mild or moderate severity.
In plain wordsIn adults with type 2 diabetes, most side effects in the trial were mild or moderate.
Peptide
Semaglutide
Outcome
Not applicableAdverse event severity
Study
n = 258
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
0.5 mg and 1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
most reported adverse events were of mild or moderate severity.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091112
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 12% discontinued semaglutide 1·0 mg versus 11% with placebo; the main reason was gastrointestinal adverse events such as nausea.
In plain wordsIn adults with type 2 diabetes, similar shares stopped treatment with semaglutide 1·0 mg (12%) and placebo (11%), mainly for digestive effects such as nausea.
Peptide
Semaglutide
Outcome
No significant changeTreatment discontinuation
Study
n = 130
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
17 (13%) of those assigned to 0·5 mg semaglutide, 16 (12%) assigned to 1·0 mg semaglutide, and 14 (11%) assigned to placebo discontinued treatment; the main reason for discontinuation was gastrointestinal adverse events such as nausea.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091106
08HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, nausea was reported in 24% with semaglutide 1·0 mg versus 8% with placebo.
In plain wordsIn adults with type 2 diabetes, nausea was more common with semaglutide 1·0 mg (24%) than with placebo (8%).
Peptide
Semaglutide
Outcome
IncreaseNausea
Study
n = 130
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
nausea was reported in 26 (20%) who received 0·5 mg semaglutide, 31 (24%) who received 1·0 mg semaglutide, and 10 (8%) who received placebo
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091108
09HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, diarrhoea was reported in 11% with semaglutide 1·0 mg versus 2% with placebo.
In plain wordsIn adults with type 2 diabetes, diarrhoea was more common with semaglutide 1·0 mg (11%) than with placebo (2%).
Peptide
Semaglutide
Outcome
IncreaseDiarrhoea
Study
n = 130
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.0 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
diarrhoea was reported in 16 (13%) who received 0·5 mg semaglutide, 14 (11%) who received 1·0 mg semaglutide, and three (2%) who received placebo
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091110
10HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 13% discontinued semaglutide 0·5 mg versus 11% with placebo; the main reason was gastrointestinal adverse events such as nausea.
In plain wordsIn adults with type 2 diabetes, similar shares stopped treatment with semaglutide 0·5 mg (13%) and placebo (11%), mainly for digestive effects such as nausea.
Peptide
Semaglutide
Outcome
No significant changeTreatment discontinuation
Study
n = 128
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
0.5 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
17 (13%) of those assigned to 0·5 mg semaglutide, 16 (12%) assigned to 1·0 mg semaglutide, and 14 (11%) assigned to placebo discontinued treatment; the main reason for discontinuation was gastrointestinal adverse events such as nausea.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091105
11HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, nausea was reported in 20% with semaglutide 0·5 mg versus 8% with placebo.
In plain wordsIn adults with type 2 diabetes, nausea was more common with semaglutide 0·5 mg (20%) than with placebo (8%).
Peptide
Semaglutide
Outcome
IncreaseNausea
Study
n = 128
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
nausea was reported in 26 (20%) who received 0·5 mg semaglutide, 31 (24%) who received 1·0 mg semaglutide, and 10 (8%) who received placebo
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091107
12HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, diarrhoea was reported in 13% with semaglutide 0·5 mg versus 2% with placebo.
In plain wordsIn adults with type 2 diabetes, diarrhoea was more common with semaglutide 0·5 mg (13%) than with placebo (2%).
Peptide
Semaglutide
Outcome
IncreaseDiarrhoea
Study
n = 128
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 mg once weekly · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
diarrhoea was reported in 16 (13%) who received 0·5 mg semaglutide, 14 (11%) who received 1·0 mg semaglutide, and three (2%) who received placebo
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Summary · context
We randomly assigned participants (2:2:1:1) to either once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo (0·5 mg or 1·0 mg), for 30 weeks via prefilled PDS290 pen-injectors.
Report a problemFND-2811091109

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

Registered trials2

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

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

Status unknownPhase 4NCT05870462

Semaglutide and Vascular Regeneration

Canadian Medical and Surgical Knowledge Translation Research Groupn = 10029 Apr 2023 to est. Dec 2024

Atherosclerosis · Cardiovascular Diseases · Diabetes Mellitus, Type 2 · Obesity

Trial page ClinicalTrials.govUpdated 25 Jul 2023

CompletedPhase 3Results postedNCT02054897

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 3883 Feb 2014 to 8 May 2015

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 12 Jun 2019

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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