Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial.

Ahrén B, Masmiquel L, Kumar H, Sargin M, Karsbøl JD, Jacobsen SH, Chow F

The lancet. Diabetes & endocrinology3 Apr 2017Cited by 408 (Europe PMC)

PMID28385659DOI10.1016/s2213-8587(17)30092-xPepBankPUB-28385659

Publisher page PubMedAsk about this study

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 study14

14 results from studies that gave the peptide. 14 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin and/or thiazolidinediones, semaglutide 0·5 mg reduced HbA1c more than sitagliptin at week 56 (difference -0·77%).
In plain wordsIn adults with type 2 diabetes, weekly semaglutide 0·5 mg lowered HbA1c more than sitagliptin after 56 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 56
Study
n = 816
Comparator
Sitagliptin 100 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.5 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
HbA_1c was reduced by 1·3% in the semaglutide 0·5 mg group, 1·6% in the semaglutide 1·0 mg group, and 0·5% with sitagliptin (estimated treatment difference vs sitagliptin -0·77% [95% CI -0·92 to -0·62] with semaglutide 0·5 mg and -1·06% [-1·21 to -0·91] with semaglutide 1·0 mg; p<0·0001 fo…
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565901
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin and/or thiazolidinediones, semaglutide 1·0 mg reduced HbA1c more than sitagliptin at week 56 (difference -1·06%).
In plain wordsIn adults with type 2 diabetes, weekly semaglutide 1·0 mg lowered HbA1c more than sitagliptin after 56 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 56
Study
n = 816
Comparator
Sitagliptin 100 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.0 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
HbA_1c was reduced by 1·3% in the semaglutide 0·5 mg group, 1·6% in the semaglutide 1·0 mg group, and 0·5% with sitagliptin (estimated treatment difference vs sitagliptin -0·77% [95% CI -0·92 to -0·62] with semaglutide 0·5 mg and -1·06% [-1·21 to -0·91] with semaglutide 1·0 mg; p<0·0001 fo…
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565902
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, semaglutide 0·5 mg reduced bodyweight more than sitagliptin at week 56 (difference -2·35 kg).
In plain wordsIn adults with type 2 diabetes, weekly semaglutide 0·5 mg reduced body weight more than sitagliptin after 56 weeks.
Peptide
Semaglutide
Outcome
DecreaseBodyweight change at week 56
Study
n = 816
Comparator
Sitagliptin 100 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
0.5 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
bodyweight reduced by 4·3 kg with semaglutide 0·5 mg, 6·1 kg with semaglutide 1·0 mg, and 1·9 kg with sitagliptin (estimated treatment difference vs sitagliptin -2·35 kg [95% CI -3·06 to -1·63] with semaglutide 0·5 mg and -4·20 kg [-4·91 to -3·49] with semaglutide 1·0 mg; p<0·0001 for superiority, f…
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565903
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, semaglutide 1·0 mg reduced bodyweight more than sitagliptin at week 56 (difference -4·20 kg).
In plain wordsIn adults with type 2 diabetes, weekly semaglutide 1·0 mg reduced body weight more than sitagliptin after 56 weeks.
Peptide
Semaglutide
Outcome
DecreaseBodyweight change at week 56
Study
n = 816
Comparator
Sitagliptin 100 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.0 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
bodyweight reduced by 4·3 kg with semaglutide 0·5 mg, 6·1 kg with semaglutide 1·0 mg, and 1·9 kg with sitagliptin (estimated treatment difference vs sitagliptin -2·35 kg [95% CI -3·06 to -1·63] with semaglutide 0·5 mg and -4·20 kg [-4·91 to -3·49] with semaglutide 1·0 mg; p<0·0001 for superiority, f…
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565904
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 8% discontinued semaglutide 0·5 mg because of adverse events versus 3% with sitagliptin.
In plain wordsIn adults with type 2 diabetes, more people stopped semaglutide 0·5 mg because of side effects (8%) than sitagliptin (3%).
Peptide
Semaglutide
Outcome
IncreaseDiscontinuation because of adverse events
Study
n = 816
Comparator
Sitagliptin 100 mg
Outcome group
Adverse events · Whole body
Studied dose
0.5 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
The proportion of patients who discontinued treatment because of adverse events was 33 (8%) for semaglutide 0·5 mg, 39 (10%) for semaglutide 1·0 mg, and 12 (3%) for sitagliptin.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565905
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 10% discontinued semaglutide 1·0 mg because of adverse events versus 3% with sitagliptin.
In plain wordsIn adults with type 2 diabetes, more people stopped semaglutide 1·0 mg because of side effects (10%) than sitagliptin (3%).
Peptide
Semaglutide
Outcome
IncreaseDiscontinuation because of adverse events
Study
n = 816
Comparator
Sitagliptin 100 mg
Outcome group
Adverse events · Whole body
Studied dose
1.0 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
The proportion of patients who discontinued treatment because of adverse events was 33 (8%) for semaglutide 0·5 mg, 39 (10%) for semaglutide 1·0 mg, and 12 (3%) for sitagliptin.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565906
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, nausea was reported in 18% with semaglutide 0·5 mg versus 7% with the pooled comparator group.
In plain wordsIn adults with type 2 diabetes, nausea was more common with semaglutide 0·5 mg (18%) than in the comparison group (7%).
Peptide
Semaglutide
Outcome
IncreaseNausea
Study
n = 816
Comparator
Sitagliptin 100 mg
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
nausea was reported in 73 (18%) who received semaglutide 0·5 mg, 72 (18%) who received semaglutide 1·0 mg, and 30 (7%) who received placebo
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565907
08HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, nausea was reported in 18% with semaglutide 1·0 mg versus 7% with the pooled comparator group.
In plain wordsIn adults with type 2 diabetes, nausea was more common with semaglutide 1·0 mg (18%) than in the comparison group (7%).
Peptide
Semaglutide
Outcome
IncreaseNausea
Study
n = 816
Comparator
Sitagliptin 100 mg
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.0 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
nausea was reported in 73 (18%) who received semaglutide 0·5 mg, 72 (18%) who received semaglutide 1·0 mg, and 30 (7%) who received placebo
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565908
09HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, diarrhoea was reported in 13% with semaglutide 0·5 mg versus 7% with the pooled comparator group.
In plain wordsIn adults with type 2 diabetes, diarrhoea was more common with semaglutide 0·5 mg (13%) than in the comparison group (7%).
Peptide
Semaglutide
Outcome
IncreaseDiarrhoea
Study
n = 816
Comparator
Sitagliptin 100 mg
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
diarrhoea was reported in 54 (13%) who received semaglutide 0·5 mg, 53 (13%) who received semaglutide 1·0 mg, and 29 (7%) who received placebo
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565909
10HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, diarrhoea was reported in 13% with semaglutide 1·0 mg versus 7% with the pooled comparator group.
In plain wordsIn adults with type 2 diabetes, diarrhoea was more common with semaglutide 1·0 mg (13%) than in the comparison group (7%).
Peptide
Semaglutide
Outcome
IncreaseDiarrhoea
Study
n = 816
Comparator
Sitagliptin 100 mg
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.0 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
diarrhoea was reported in 54 (13%) who received semaglutide 0·5 mg, 53 (13%) who received semaglutide 1·0 mg, and 29 (7%) who received placebo
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565910
11HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, blood-glucose confirmed hypoglycaemia occurred in 2% with semaglutide 0·5 mg and 1% with sitagliptin.
In plain wordsIn adults with type 2 diabetes, confirmed low blood sugar was uncommon with semaglutide 0·5 mg (2%) and with sitagliptin (1%).
Peptide
Semaglutide
Outcome
No significant changeBlood-glucose confirmed hypoglycaemia
Study
n = 816
Comparator
Sitagliptin 100 mg
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.5 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
Seven (2%) patients in the semaglutide 0·5 mg group, two (<1%) in the semaglutide 1·0 mg group, and five (1%) in the sitagliptin group had blood-glucose confirmed hypoglycaemia.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565911
12HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, blood-glucose confirmed hypoglycaemia occurred in fewer than 1% with semaglutide 1·0 mg and 1% with sitagliptin.
In plain wordsIn adults with type 2 diabetes, confirmed low blood sugar was uncommon with semaglutide 1·0 mg and with sitagliptin.
Peptide
Semaglutide
Outcome
No significant changeBlood-glucose confirmed hypoglycaemia
Study
n = 816
Comparator
Sitagliptin 100 mg
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.0 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
Seven (2%) patients in the semaglutide 0·5 mg group, two (<1%) in the semaglutide 1·0 mg group, and five (1%) in the sitagliptin group had blood-glucose confirmed hypoglycaemia.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565912
13HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, two fatal events occurred in the semaglutide 0·5 mg group; none was considered likely related to the trial drugs.
In plain wordsIn adults with type 2 diabetes, two people on semaglutide 0·5 mg died; the deaths were not judged likely to be related to the drug.
Peptide
Semaglutide
Outcome
Not applicableFatal events
Study
n = 409
Outcome group
Mortality · Whole body
Studied dose
0.5 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
There were six fatal events (two in the semaglutide 0·5 mg group, one in the semaglutide 1·0 mg group, and three in the sitagliptin group); none were considered likely to be related to the trial drugs.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565913
14HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, one fatal event occurred in the semaglutide 1·0 mg group; none was considered likely related to the trial drugs.
In plain wordsIn adults with type 2 diabetes, one person on semaglutide 1·0 mg died; the death was not judged likely to be related to the drug.
Peptide
Semaglutide
Outcome
Not applicableFatal events
Study
n = 409
Outcome group
Mortality · Whole body
Studied dose
1.0 mg once weekly · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
There were six fatal events (two in the semaglutide 0·5 mg group, one in the semaglutide 1·0 mg group, and three in the sitagliptin group); none were considered likely to be related to the trial drugs.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.
Summary · context
We did a 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries.
Report a problemFND-2838565914

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 postedNCT01930188

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 1,2312 Dec 2013 to 12 Oct 2015

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 13 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.

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