Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36-week, randomized, double-blind, parallel-group trial.

Seino Y, Kaneko S, Fukuda S, Osonoi T, Shiraiwa T, Nishijima K, Bosch-Traberg H, Kaku K

Journal of diabetes investigation23 Jan 2016Cited by 50 (Europe PMC)

PMID27182042PMCIDPMC4931207DOI10.1111/jdi.12457PepBankPUB-27182042

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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: CC BY-NC-ND. 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 on insulin, adding liraglutide lowered HbA1c more than placebo at week 16.
In plain wordsIn Japanese adults with type 2 diabetes using insulin, adding liraglutide lowered HbA1c more than adding placebo.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change after 16 weeks
Study
n = 257
Comparator
Placebo plus insulin
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg/day · 36 weeksAs given in this study (human).
Measurements
Estimated mean difference in HbA1c
−1.3%
week 16
Source sentences
Summary
Superiority of liraglutide plus insulin versus insulin monotherapy was confirmed based on estimated mean difference in glycosylated hemoglobin after 16 weeks of -1.30% (-14 mmol/mol; 95% confidence interval -1.47 to -1.13 [-16, -12]; P < 0.0001).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary end-point was change in glycosylated hemoglobin after 16 weeks.
Summary · context
This was a 36-week, multicenter, double-blind, parallel-group trial, where patients on stable insulin therapy (basal/premixed/basal-bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130).
Report a problemFND-2718204201
02HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes on insulin, the HbA1c advantage of liraglutide over placebo remained significant to week 36.
In plain wordsIn Japanese adults with type 2 diabetes using insulin, liraglutide kept its HbA1c benefit over placebo to week 36.
Peptide
Liraglutide
Outcome
DecreaseHbA1c difference maintained to week 36
Study
n = 257
Comparator
Placebo plus insulin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg/day · 36 weeksAs given in this study (human).
Source sentences
Summary
Statistical significance was maintained to week 36.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a 36-week, multicenter, double-blind, parallel-group trial, where patients on stable insulin therapy (basal/premixed/basal-bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130).
Report a problemFND-2718204202
03HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes on insulin, more patients on liraglutide than on placebo reached HbA1c below 7.0% at week 16.
In plain wordsIn Japanese adults with type 2 diabetes using insulin, more people reached HbA1c below 7.0% with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseHbA1c below 7.0% at week 16
Study
n = 257
Comparator
Placebo plus insulin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg/day · 36 weeksAs given in this study (human).
Measurements
Estimated odds ratio
50.57 ratio
HbA1c <7.0% at week 16
Source sentences
Summary
More patients on liraglutide achieved a glycosylated hemoglobin target of <7.0% (<53 mmol/mol) at week 16 (estimated odds ratio 50.57; 95% confidence interval 16.59 to 154.16; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This was a 36-week, multicenter, double-blind, parallel-group trial, where patients on stable insulin therapy (basal/premixed/basal-bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130).
Report a problemFND-2718204203
04HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes on insulin, seven-point self-measured plasma glucose improved significantly more with liraglutide than with placebo at week 16.
In plain wordsIn Japanese adults with type 2 diabetes using insulin, home-measured glucose improved more with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
DecreaseSeven-point self-measured plasma glucose at week 16
Study
n = 257
Comparator
Placebo plus insulin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg/day · 36 weeksAs given in this study (human).
Source sentences
Summary
Improvements in seven-point self-measured plasma glucose
1 context sentence(design, population, supporting numbers)
Summary · context
This was a 36-week, multicenter, double-blind, parallel-group trial, where patients on stable insulin therapy (basal/premixed/basal-bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130).
Report a problemFND-2718204204
05HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes on insulin, fasting plasma glucose improved significantly more with liraglutide than with placebo at week 16.
In plain wordsIn Japanese adults with type 2 diabetes using insulin, fasting glucose improved more with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
DecreaseFasting plasma glucose at week 16
Study
n = 257
Comparator
Placebo plus insulin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg/day · 36 weeksAs given in this study (human).
Source sentences
Summary
Improvements in seven-point self-measured plasma glucose and fasting plasma glucose were significantly greater with liraglutide than the placebo at week 16.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a 36-week, multicenter, double-blind, parallel-group trial, where patients on stable insulin therapy (basal/premixed/basal-bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130).
Report a problemFND-2718204205
06HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, insulin dose after 36 weeks was lower with liraglutide than with placebo.
In plain wordsIn Japanese adults with type 2 diabetes, people on liraglutide needed less insulin than people on placebo after 36 weeks.
Peptide
Liraglutide
Outcome
DecreaseInsulin dose after 36 weeks
Study
n = 257
Comparator
Placebo plus insulin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg/day · 36 weeksAs given in this study (human).
Measurements
Estimated treatment ratio of insulin dose
0.82 ratio
week 36
Source sentences
Summary
Insulin dose after 36 weeks was lower with liraglutide than the placebo (estimated treatment ratio: 0.82 [95% confidence interval 0.76-0.90; P < 0.0001]).
1 context sentence(design, population, supporting numbers)
Summary · context
This was a 36-week, multicenter, double-blind, parallel-group trial, where patients on stable insulin therapy (basal/premixed/basal-bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130).
Report a problemFND-2718204206
07HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes on insulin, adverse events occurred at a similar rate with liraglutide and placebo, and most were mild.
In plain wordsIn Japanese adults with type 2 diabetes using insulin, side effects were similar with liraglutide and placebo, and most were mild.
Peptide
Liraglutide
Outcome
No significant changeAdverse event occurrence
Study
n = 257
Comparator
Placebo plus insulin
Outcome group
Adverse events · Whole body
Studied dose
0.9 mg/day · 36 weeksAs given in this study (human).
Source sentences
Summary
Occurrence of adverse events was similar in the two groups (85.8 and 81.5%, respectively); most were mild in severity.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a 36-week, multicenter, double-blind, parallel-group trial, where patients on stable insulin therapy (basal/premixed/basal-bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130).
Report a problemFND-2718204207
08HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes on insulin, the number of hypoglycemic episodes over 36 weeks did not differ significantly between liraglutide and placebo.
In plain wordsIn Japanese adults with type 2 diabetes using insulin, low blood sugar episodes did not differ between liraglutide and placebo.
Peptide
Liraglutide
Outcome
No significant changeHypoglycemic episodes over 36 weeks
Study
n = 257
Comparator
Placebo plus insulin
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.9 mg/day · 36 weeksAs given in this study (human).
Source sentences
Summary
There were no significant differences in the number of hypoglycemic episodes during the 36 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a 36-week, multicenter, double-blind, parallel-group trial, where patients on stable insulin therapy (basal/premixed/basal-bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130).
Report a problemFND-2718204208

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 postedNCT01572740

Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 2575 Apr 2012 to 27 Mar 2013

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 7 Feb 2018

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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