Efficacy and safety over 26 weeks of an oral treatment strategy including sitagliptin compared with an injectable treatment strategy with liraglutide in patients with type 2 diabetes mellitus inadequately controlled on metformin: a randomised clinical trial.

Charbonnel B, Steinberg H, Eymard E, Xu L, Thakkar P, Prabhu V, Davies MJ, Engel SS

Diabetologia19 Apr 2013Cited by 54 (Europe PMC)

PMID23604551DOI10.1007/s00125-013-2905-1PepBankPUB-23604551

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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, the liraglutide strategy lowered HbA1c by 1.4% at week 26; the oral strategy was non-inferior.
In plain wordsIn adults with type 2 diabetes on metformin, HbA1c fell by 1.4% with the liraglutide strategy, similar to the oral strategy.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change at week 26
Study
n = 253
Comparator
Oral strategy (sitagliptin, then glimepiride if needed)
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6 mg/day, up-titrated to 1.2 mg/day after 1 week, and to 1.8 mg/day if needed after 12 weeks · injectable · 26 weeksAs given in this study (human).
Measurements
LS mean HbA1c change
−1.4%
injectable strategy
Source sentences
Summary
The LS mean change in HbA1c at week 26 was -1.3% (95% CI -1.4, -1.2) in the oral strategy group and -1.4% (95% CI -1.5, -1.3) in the injectable strategy group; the study met the non-inferiority criterion.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary analysis assessed whether the strategy using oral drugs was non-inferior to that using an injectable drug regarding HbA1c change from baseline at week 26 using a per-protocol (PP) population and a non-inferiority margin of 0.4%.
Summary · context
In a 26 week, open-label study, 653 patients (baseline HbA1c = 8.2% [66 mmol/mol]) were randomised at 111 sites in 21 countries in a 1:1 ratio to a strategy using oral agents (starting with sitagliptin 100 mg/day) or a strategy using the injectable drug liraglutide starting at a dose of 0.6 mg/day,…
Report a problemFND-2360455101
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, the liraglutide strategy gave a larger initial HbA1c reduction at week 12 than the oral strategy.
In plain wordsIn adults with type 2 diabetes, HbA1c fell faster in the first 12 weeks with liraglutide than with the oral strategy.
Peptide
Liraglutide
Outcome
DecreaseHbA1c reduction at week 12
Study
n = 253
Comparator
Oral strategy (sitagliptin, then glimepiride if needed)
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6 mg/day, up-titrated to 1.2 mg/day after 1 week, and to 1.8 mg/day if needed after 12 weeks · injectable · 26 weeksAs given in this study (human).
Source sentences
Summary
HbA1c decreased over 26 weeks in both treatment strategy groups, with a larger initial reduction at week 12 in the injectable strategy group.
1 context sentence(design, population, supporting numbers)
Summary · context
In a 26 week, open-label study, 653 patients (baseline HbA1c = 8.2% [66 mmol/mol]) were randomised at 111 sites in 21 countries in a 1:1 ratio to a strategy using oral agents (starting with sitagliptin 100 mg/day) or a strategy using the injectable drug liraglutide starting at a dose of 0.6 mg/day,…
Report a problemFND-2360455102
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, liraglutide therapy was intensified at week 12 in 28.5% of patients, against 50.2% with the oral strategy.
In plain wordsIn adults with type 2 diabetes, 28.5% needed more treatment at week 12 on liraglutide, against 50.2% on the oral strategy.
Peptide
Liraglutide
Outcome
Not applicableTreatment intensification at week 12
Study
n = 253
Comparator
Oral strategy (sitagliptin, then glimepiride if needed)
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6 mg/day, up-titrated to 1.2 mg/day after 1 week, and to 1.8 mg/day if needed after 12 weeks · injectable · 26 weeksAs given in this study (human).
Measurements
Intensified at week 12
28.5%
injectable strategy
Intensified at week 12
50.2%
oral strategy
Source sentences
Summary
In the PP population (522 patients included: oral strategy, n = 269; injectable strategy, n = 253) antihyperglycaemic therapy was intensified at week 12 in 50.2% and 28.5%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a 26 week, open-label study, 653 patients (baseline HbA1c = 8.2% [66 mmol/mol]) were randomised at 111 sites in 21 countries in a 1:1 ratio to a strategy using oral agents (starting with sitagliptin 100 mg/day) or a strategy using the injectable drug liraglutide starting at a dose of 0.6 mg/day,…
Report a problemFND-2360455103
04HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin, nausea was reported more often with the liraglutide strategy than with the oral strategy.
In plain wordsIn adults with type 2 diabetes, nausea was reported more often with liraglutide than with the oral strategy.
Peptide
Liraglutide
Outcome
IncreaseNausea
Study
n: not reported in source
Comparator
Oral strategy (sitagliptin, then glimepiride if needed)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.6 mg/day, up-titrated to 1.2 mg/day after 1 week, and to 1.8 mg/day if needed after 12 weeks · injectable · 26 weeksAs given in this study (human).
Source sentences
Summary
while nausea, vomiting, diarrhoea and abdominal pain were reported more often with the injectable strategy.
1 context sentence(design, population, supporting numbers)
Summary · context
In a 26 week, open-label study, 653 patients (baseline HbA1c = 8.2% [66 mmol/mol]) were randomised at 111 sites in 21 countries in a 1:1 ratio to a strategy using oral agents (starting with sitagliptin 100 mg/day) or a strategy using the injectable drug liraglutide starting at a dose of 0.6 mg/day,…
Report a problemFND-2360455104
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin, vomiting was reported more often with the liraglutide strategy than with the oral strategy.
In plain wordsIn adults with type 2 diabetes, vomiting was reported more often with liraglutide than with the oral strategy.
Peptide
Liraglutide
Outcome
IncreaseVomiting
Study
n: not reported in source
Comparator
Oral strategy (sitagliptin, then glimepiride if needed)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.6 mg/day, up-titrated to 1.2 mg/day after 1 week, and to 1.8 mg/day if needed after 12 weeks · injectable · 26 weeksAs given in this study (human).
Source sentences
Summary
while nausea, vomiting, diarrhoea and abdominal pain were reported more often with the injectable strategy.
1 context sentence(design, population, supporting numbers)
Summary · context
In a 26 week, open-label study, 653 patients (baseline HbA1c = 8.2% [66 mmol/mol]) were randomised at 111 sites in 21 countries in a 1:1 ratio to a strategy using oral agents (starting with sitagliptin 100 mg/day) or a strategy using the injectable drug liraglutide starting at a dose of 0.6 mg/day,…
Report a problemFND-2360455105
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin, diarrhoea was reported more often with the liraglutide strategy than with the oral strategy.
In plain wordsIn adults with type 2 diabetes, diarrhoea was reported more often with liraglutide than with the oral strategy.
Peptide
Liraglutide
Outcome
IncreaseDiarrhoea
Study
n: not reported in source
Comparator
Oral strategy (sitagliptin, then glimepiride if needed)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.6 mg/day, up-titrated to 1.2 mg/day after 1 week, and to 1.8 mg/day if needed after 12 weeks · injectable · 26 weeksAs given in this study (human).
Source sentences
Summary
while nausea, vomiting, diarrhoea and abdominal pain were reported more often with the injectable strategy.
1 context sentence(design, population, supporting numbers)
Summary · context
In a 26 week, open-label study, 653 patients (baseline HbA1c = 8.2% [66 mmol/mol]) were randomised at 111 sites in 21 countries in a 1:1 ratio to a strategy using oral agents (starting with sitagliptin 100 mg/day) or a strategy using the injectable drug liraglutide starting at a dose of 0.6 mg/day,…
Report a problemFND-2360455106
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin, abdominal pain was reported more often with the liraglutide strategy than with the oral strategy.
In plain wordsIn adults with type 2 diabetes, abdominal pain was reported more often with liraglutide than with the oral strategy.
Peptide
Liraglutide
Outcome
IncreaseAbdominal pain
Study
n: not reported in source
Comparator
Oral strategy (sitagliptin, then glimepiride if needed)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.6 mg/day, up-titrated to 1.2 mg/day after 1 week, and to 1.8 mg/day if needed after 12 weeks · injectable · 26 weeksAs given in this study (human).
Source sentences
Summary
while nausea, vomiting, diarrhoea and abdominal pain were reported more often with the injectable strategy.
1 context sentence(design, population, supporting numbers)
Summary · context
In a 26 week, open-label study, 653 patients (baseline HbA1c = 8.2% [66 mmol/mol]) were randomised at 111 sites in 21 countries in a 1:1 ratio to a strategy using oral agents (starting with sitagliptin 100 mg/day) or a strategy using the injectable drug liraglutide starting at a dose of 0.6 mg/day,…
Report a problemFND-2360455107
08HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin, hypoglycaemia was reported less often with the liraglutide strategy than with the oral strategy.
In plain wordsIn adults with type 2 diabetes, low blood sugar was reported less often with liraglutide than with the oral strategy.
Peptide
Liraglutide
Outcome
DecreaseHypoglycaemia
Study
n: not reported in source
Comparator
Oral strategy (sitagliptin, then glimepiride if needed)
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.6 mg/day, up-titrated to 1.2 mg/day after 1 week, and to 1.8 mg/day if needed after 12 weeks · injectable · 26 weeksAs given in this study (human).
Source sentences
Summary
Both treatment regimens were generally well tolerated; hypoglycaemia was reported more often with the oral strategy
1 context sentence(design, population, supporting numbers)
Summary · context
In a 26 week, open-label study, 653 patients (baseline HbA1c = 8.2% [66 mmol/mol]) were randomised at 111 sites in 21 countries in a 1:1 ratio to a strategy using oral agents (starting with sitagliptin 100 mg/day) or a strategy using the injectable drug liraglutide starting at a dose of 0.6 mg/day,…
Report a problemFND-2360455108

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 postedNCT01296412

Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

Merck Sharp & Dohme LLCn = 65311 Mar 2011 to 29 Feb 2012

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 9 Jun 2017

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
12 Oct 2026, 12:10 UTC
Study results updated
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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