A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes.

Nauck MA, Petrie JR, Sesti G, Mannucci E, Courrèges JP, Lindegaard ML, Jensen CB, Atkin SL

Diabetes care10 Sept 2015Cited by 180 (Europe PMC)

PMID26358288DOI10.2337/dc15-0165PepBankPUB-26358288

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 patients with type 2 diabetes, semaglutide dose-dependently reduced HbA1c from baseline to week 12, by up to 1.7%.
In plain wordsIn people with type 2 diabetes, semaglutide lowered HbA1c in a dose-dependent way, by up to 1.7% after 12 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change from baseline to week 12
Study
n: not reported in source
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.1-1.6 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
HbA1c change
−1.7%
semaglutide, up to
Source sentences
Summary
Semaglutide dose-dependently reduced the level of HbA1c from baseline (8.1 ± 0.8%) to week 12 by up to -1.7%
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
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02HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, semaglutide reduced body weight by up to 4.8 kg (1.6 mg with escalation) versus placebo.
In plain wordsIn people with type 2 diabetes, semaglutide lowered body weight by up to 4.8 kg, more than placebo, after 12 weeks.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 12
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.6 mg once weekly with dose escalation · subcutaneous · 12 weeksAs given in this study (human).
Measurements
body weight change
−4.8 kg
semaglutide 1.6 mg E
Source sentences
Summary
Semaglutide dose-dependently reduced the level of HbA1c from baseline (8.1 ± 0.8%) to week 12 by up to -1.7%, and body weight by up to -4.8 kg (1.6 mg E, P < 0.001 vs. placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
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03HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, up to 81% of patients on semaglutide reached an HbA1c below 7%.
In plain wordsIn people with type 2 diabetes, up to 81% of those on semaglutide reached an HbA1c below 7% after 12 weeks.
Peptide
Semaglutide
Outcome
Not applicablePatients achieving HbA1c below 7%
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.1-1.6 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
patients with HbA1c <7%
≤ 81%
semaglutide
Source sentences
Summary
Up to 81% of patients achieved an HbA1c level of <7%.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828803
04HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, HbA1c reduction with semaglutide 1.6 mg E was greater than with liraglutide 1.2 and 1.8 mg, based on unadjusted CIs.
In plain wordsIn people with type 2 diabetes, semaglutide at the top dose lowered HbA1c more than liraglutide did, judged by unadjusted confidence intervals.
Peptide
Semaglutide
Outcome
DecreaseHbA1c reduction versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 1.2 and 1.8 mg
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.6 mg once weekly with dose escalation · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
HbA1c level and weight reductions with semaglutide 1.6 mg E were greater than those with liraglutide 1.2 and 1.8 mg (based on unadjusted CIs)
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828804
05HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, weight reduction with semaglutide 1.6 mg E was greater than with liraglutide 1.2 and 1.8 mg, based on unadjusted CIs.
In plain wordsIn people with type 2 diabetes, semaglutide at the top dose lowered weight more than liraglutide did, judged by unadjusted confidence intervals.
Peptide
Semaglutide
Outcome
DecreaseWeight reduction versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 1.2 and 1.8 mg
Outcome group
Body weight · Metabolic and weight
Studied dose
1.6 mg once weekly with dose escalation · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
HbA1c level and weight reductions with semaglutide 1.6 mg E were greater than those with liraglutide 1.2 and 1.8 mg (based on unadjusted CIs)
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828805
06HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, HbA1c reduction with open-label liraglutide 1.2 and 1.8 mg was smaller than with semaglutide 1.6 mg E, based on unadjusted CIs.
In plain wordsIn people with type 2 diabetes, liraglutide lowered HbA1c less than semaglutide at the top dose, judged by unadjusted confidence intervals.
Peptide
Liraglutide
Outcome
Not applicableHbA1c reduction compared with semaglutide 1.6 mg E
Study
n: not reported in source
Comparator
Semaglutide 1.6 mg E
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 or 1.8 mg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
HbA1c level and weight reductions with semaglutide 1.6 mg E were greater than those with liraglutide 1.2 and 1.8 mg (based on unadjusted CIs)
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828806
07HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, weight reduction with open-label liraglutide 1.2 and 1.8 mg was smaller than with semaglutide 1.6 mg E, based on unadjusted CIs.
In plain wordsIn people with type 2 diabetes, liraglutide lowered weight less than semaglutide at the top dose, judged by unadjusted confidence intervals.
Peptide
Liraglutide
Outcome
Not applicableWeight reduction compared with semaglutide 1.6 mg E
Study
n: not reported in source
Comparator
Semaglutide 1.6 mg E
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 or 1.8 mg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
HbA1c level and weight reductions with semaglutide 1.6 mg E were greater than those with liraglutide 1.2 and 1.8 mg (based on unadjusted CIs)
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828807
08HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, adverse events occurred more frequently with semaglutide 1.6 mg E than with liraglutide.
In plain wordsIn people with type 2 diabetes, side effects were more common with semaglutide at the top dose than with liraglutide.
Peptide
Semaglutide
Outcome
IncreaseAdverse events versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 1.2 and 1.8 mg
Outcome group
Adverse events · Whole body
Studied dose
1.6 mg once weekly with dose escalation · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
but adverse events (AEs) and withdrawals occurred more frequently.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828808
09HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, withdrawals occurred more frequently with semaglutide 1.6 mg E than with liraglutide.
In plain wordsIn people with type 2 diabetes, more people stopped treatment with semaglutide at the top dose than with liraglutide.
Peptide
Semaglutide
Outcome
IncreaseWithdrawals versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 1.2 and 1.8 mg
Outcome group
Adverse events · Whole body
Studied dose
1.6 mg once weekly with dose escalation · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
but adverse events (AEs) and withdrawals occurred more frequently.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828809
10HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, the incidence of nausea increased with the semaglutide dose; most events were mild to moderate and transient.
In plain wordsIn people with type 2 diabetes, nausea became more common as the semaglutide dose went up; most cases were mild to moderate.
Peptide
Semaglutide
Outcome
IncreaseNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.1-1.6 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
The incidence of nausea, vomiting, and withdrawal due to gastrointestinal AEs increased with the semaglutide dose; most events were mild to moderate, transient, and ameliorated by dose escalation.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828810
11HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, the incidence of vomiting increased with the semaglutide dose; most events were mild to moderate and transient.
In plain wordsIn people with type 2 diabetes, vomiting became more common as the semaglutide dose went up; most cases were mild to moderate.
Peptide
Semaglutide
Outcome
IncreaseVomiting
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.1-1.6 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
The incidence of nausea, vomiting, and withdrawal due to gastrointestinal AEs increased with the semaglutide dose; most events were mild to moderate, transient, and ameliorated by dose escalation.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828811
12HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, withdrawal due to gastrointestinal adverse events increased with the semaglutide dose.
In plain wordsIn people with type 2 diabetes, more people stopped semaglutide because of stomach and gut side effects as the dose went up.
Peptide
Semaglutide
Outcome
IncreaseWithdrawal due to gastrointestinal adverse events
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.1-1.6 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
The incidence of nausea, vomiting, and withdrawal due to gastrointestinal AEs increased with the semaglutide dose; most events were mild to moderate, transient, and ameliorated by dose escalation.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828812
13HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, there were no major episodes of hypoglycemia in the trial.
In plain wordsIn people with type 2 diabetes, the trial saw no major episodes of low blood sugar.
Peptide
Semaglutide
Outcome
No significant changeMajor hypoglycemia episodes
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.1-1.6 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
There were no major episodes of hypoglycemia
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828813
14HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, there were few cases of injection site reactions in the trial.
In plain wordsIn people with type 2 diabetes, the trial saw few cases of reactions at the injection site.
Peptide
Semaglutide
Outcome
Not applicableInjection site reactions
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
0.1-1.6 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
few cases of injection site reactions.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 12-week, randomized, double-blind phase 2 trial.
Summary · context
Patients (n = 415) were randomized to receive a subcutaneous injection of semaglutide once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo.
Report a problemFND-2635828814

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 2Results postedNCT00696657

A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

Novo Nordisk A/Sn = 4153 Jun 2008 to 5 Feb 2009

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 14 Aug 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 3Current
12 Oct 2026, 12:10 UTC
Study results updated
Version 2
9 Oct 2026, 03:06 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC