Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes.

Seino Y, Rasmussen MF, Nishida T, Kaku K

Current medical research and opinion1 May 2010Cited by 91 (Europe PMC)

PMID20199137DOI10.1185/03007991003672551PepBankPUB-20199137

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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 study8

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

01HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, liraglutide gave lower HbA1c at 24 weeks than glibenclamide.
In plain wordsIn Japanese adults with type 2 diabetes, liraglutide lowered HbA1c more than glibenclamide after 24 weeks.
Peptide
Liraglutide
Outcome
DecreaseHbA1c at 24 weeks
Study
n = 411
Comparator
Glibenclamide
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg once daily (maximum planned dose) · 24 weeksAs given in this study (human).
Measurements
HbA1c
6.99%
liraglutide
HbA1c
7.5%
glibenclamide
Difference
−0.5%
liraglutide vs glibenclamide
Source sentences
Summary
After 24 weeks, glycaemic control with liraglutide was non-inferior/superior to glibenclamide, with HbA(1C) at 24 weeks of 6.99% (SE +/- 0.07) with liraglutide and 7.50% (+/-0.09) with glibenclamide (difference, -0.5%; 95% CI -0.70 to 0.30; p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy.
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02HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, mean fasting plasma glucose at 24 weeks was lower with liraglutide than with glibenclamide.
In plain wordsIn Japanese adults with type 2 diabetes, liraglutide gave lower fasting blood glucose than glibenclamide after 24 weeks.
Peptide
Liraglutide
Outcome
DecreaseFasting plasma glucose at 24 weeks
Study
n = 411
Comparator
Glibenclamide
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg once daily (maximum planned dose) · 24 weeksAs given in this study (human).
Measurements
FPG
7.6 mmol/l
liraglutide
FPG
8.3 mmol/l
glibenclamide
Difference
−0.72 mmol/l
liraglutide vs glibenclamide
Source sentences
Summary
Mean fasting plasma glucose (FPG) levels at 24 weeks were significantly lower with liraglutide (7.6 mmol/l [SE +/- 0.1]) vs glibenclamide (8.3 mmol/l [+/-0.1]; difference, -0.72 mmol/l; 95% CI -1.0 to -0.4; p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy.
Report a problemFND-2019913702
03HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, body weight fell with liraglutide and rose with glibenclamide, a difference of -1.91 kg.
In plain wordsIn Japanese adults with type 2 diabetes, weight fell with liraglutide but rose with glibenclamide.
Peptide
Liraglutide
Outcome
DecreaseBody weight change
Study
n = 411
Comparator
Glibenclamide
Outcome group
Body weight · Metabolic and weight
Studied dose
0.9 mg once daily (maximum planned dose) · 24 weeksAs given in this study (human).
Measurements
Weight change
−0.92 kg
liraglutide
Weight change
0.99 kg
glibenclamide
Difference
−1.91 kg
liraglutide vs glibenclamide
Source sentences
Summary
Weight was reduced by -0.92 kg from a baseline of 65.2 kg in liraglutide-treated patients, compared with weight gain of +0.99 kg from a baseline of 64.8 kg with glibenclamide (difference, -1.91 kg; 95% CI -2.34 to -1.48; p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy.
Report a problemFND-2019913703
04HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, liraglutide caused a lower rate of minor hypoglycaemic episodes than glibenclamide.
In plain wordsIn Japanese adults with type 2 diabetes, liraglutide caused fewer minor low blood sugar episodes than glibenclamide.
Peptide
Liraglutide
Outcome
DecreaseMinor hypoglycaemic episodes
Study
n = 411
Comparator
Glibenclamide
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.9 mg once daily (maximum planned dose) · 24 weeksAs given in this study (human).
Source sentences
Summary
A significantly lower rate of minor hypoglycaemic episodes was achieved with liraglutide compared with glibenclamide (p < 0.0001)
1 context sentence(design, population, supporting numbers)
Summary · context
This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy.
Report a problemFND-2019913704
05HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, no major hypoglycaemic episodes were reported in either the liraglutide or the glibenclamide group.
In plain wordsIn Japanese adults with type 2 diabetes, nobody on liraglutide or glibenclamide had a major low blood sugar episode.
Peptide
Liraglutide
Outcome
No significant changeMajor hypoglycaemic episodes
Study
n = 411
Comparator
Glibenclamide
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.9 mg once daily (maximum planned dose) · 24 weeksAs given in this study (human).
Source sentences
Summary
no major hypoglycaemic episodes were reported in either treatment group.
1 context sentence(design, population, supporting numbers)
Summary · context
This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy.
Report a problemFND-2019913705
06HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, diarrhoea occurred in 6.3% with liraglutide and 3.8% with glibenclamide; no test was reported.
In plain wordsDiarrhoea was reported by 6.3% on liraglutide and 3.8% on glibenclamide in Japanese adults with type 2 diabetes.
Peptide
Liraglutide
Outcome
Direction not reportedDiarrhoea
Study
n = 411
Comparator
Glibenclamide
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.9 mg once daily (maximum planned dose) · 24 weeksAs given in this study (human).
Measurements
Incidence
6.3%
liraglutide
Incidence
3.8%
glibenclamide
Source sentences
Summary
The most common gastrointestinal AEs were diarrhoea (liraglutide, 6.3%; glibenclamide, 3.8%) and constipation (liraglutide, 5.6%; glibenclamide, 3.8%).
1 context sentence(design, population, supporting numbers)
Summary · context
This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy.
Report a problemFND-2019913706
07HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, constipation occurred in 5.6% with liraglutide and 3.8% with glibenclamide; no test was reported.
In plain wordsConstipation was reported by 5.6% on liraglutide and 3.8% on glibenclamide in Japanese adults with type 2 diabetes.
Peptide
Liraglutide
Outcome
Direction not reportedConstipation
Study
n = 411
Comparator
Glibenclamide
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.9 mg once daily (maximum planned dose) · 24 weeksAs given in this study (human).
Measurements
Incidence
5.6%
liraglutide
Incidence
3.8%
glibenclamide
Source sentences
Summary
The most common gastrointestinal AEs were diarrhoea (liraglutide, 6.3%; glibenclamide, 3.8%) and constipation (liraglutide, 5.6%; glibenclamide, 3.8%).
1 context sentence(design, population, supporting numbers)
Summary · context
This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy.
Report a problemFND-2019913707
08HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, nausea was infrequent: 4.5% with liraglutide and 1.5% with glibenclamide.
In plain wordsNausea was uncommon: 4.5% on liraglutide and 1.5% on glibenclamide in Japanese adults with type 2 diabetes.
Peptide
Liraglutide
Outcome
Direction not reportedNausea
Study
n = 411
Comparator
Glibenclamide
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.9 mg once daily (maximum planned dose) · 24 weeksAs given in this study (human).
Measurements
Incidence
4.5%
liraglutide
Incidence
1.5%
glibenclamide
Source sentences
Summary
Nausea was infrequent (liraglutide, 4.5%; glibenclamide, 1.5%).
1 context sentence(design, population, supporting numbers)
Summary · context
This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy.
Report a problemFND-2019913708

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 postedNCT00393718

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 400Nov 2006 to May 2008

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 8 Mar 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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MeSH terms

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