Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide is non-inferior to once-daily liraglutide and superior to placebo in Japanese patients with type 2 diabetes: a 26-week randomized phase III study.

Miyagawa J, Odawara M, Takamura T, Iwamoto N, Takita Y, Imaoka T

Diabetes, obesity & metabolism20 Aug 2015Cited by 83 (Europe PMC)

PMID26179187PMCIDPMC5042083DOI10.1111/dom.12534PepBankPUB-26179187

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Summary

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Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study15

15 results from studies that gave the peptide. 15 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, dulaglutide reduced HbA1c more than placebo at 26 weeks.
In plain wordsDulaglutide reduced long-term blood sugar more than placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c change versus placebo
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg once weekly · 26 weeksAs given in this study (human).
Measurements
HbA1c least squares mean difference
−1.57%
dulaglutide versus placebo
95% CI lower
−1.79%
dulaglutide versus placebo
95% CI upper
−1.35%
dulaglutide versus placebo
Source sentences
Summary
At 26 weeks, once-weekly dulaglutide was superior to placebo and non-inferior to once-daily liraglutide for HbA1c change from baseline [least squares mean difference: dulaglutide vs placebo -1.57% (95% confidence interval -1.79 to -1.35)
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective evaluated the superiority of dulaglutide versus placebo on change from baseline in glycated haemoglobin (HbA1c) at 26 weeks.
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918705
02HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, decreased appetite was reported more often with liraglutide (n = 8, 5.8%) than with dulaglutide (n = 2, 0.7%).
In plain wordsIn Japanese patients with type 2 diabetes, decreased appetite was reported more often with liraglutide than with dulaglutide.
Peptide
Liraglutide
Outcome
IncreaseDecreased appetite adverse event
Study
n = 141
Comparator
Dulaglutide 0.75 mg once weekly
Outcome group
Adverse events · Gastrointestinal
Studied dose
0.9 mg once dailyAs given in this study (human).
Measurements
decreased appetite
8 patients
liraglutide
decreased appetite
5.8%
liraglutide
Source sentences
Summary
The most frequently reported adverse events were nasopharyngitis, constipation, diarrhoea, nausea, abdominal distension and decreased appetite; only decreased appetite was different between the dulaglutide and liraglutide groups [dulaglutide, n = 2 (0.7%); liraglutide, n = 8 (5.8%); p = 0.003].
1 context sentence(design, population, supporting numbers)
Summary · context
This was a phase III, 52-week (26-week primary endpoint), randomized, double-blind, placebo-controlled, open-label comparator (liraglutide) trial comparing 492 Japanese patients with type 2 diabetes (dulaglutide, n = 281; liraglutide, n = 141; and placebo, n = 70) who were aged ≥20 years.
Report a problemFND-2617918702
03HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, 2 patients (1.5%) on liraglutide had hypoglycaemia, and no hypoglycaemia event in the trial was severe.
In plain wordsIn Japanese patients with type 2 diabetes, 2 patients on liraglutide had low blood sugar, and no event in the trial was severe.
Peptide
Liraglutide
Outcome
Not applicableHypoglycaemia
Study
n = 141
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.9 mg once dailyAs given in this study (human).
Measurements
hypoglycaemia
2 patients
liraglutide
hypoglycaemia
1.5%
liraglutide
Source sentences
Summary
Nine (1.8%) patients experienced hypoglycaemia [dulaglutide, n = 6 (2.1%); liraglutide, n = 2 (1.5%); placebo, n = 1 (1.4%)], with no event being severe.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a phase III, 52-week (26-week primary endpoint), randomized, double-blind, placebo-controlled, open-label comparator (liraglutide) trial comparing 492 Japanese patients with type 2 diabetes (dulaglutide, n = 281; liraglutide, n = 141; and placebo, n = 70) who were aged ≥20 years.
Report a problemFND-2617918704
04HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, the HbA1c change with once-daily liraglutide 0.9 mg was similar to that with once-weekly dulaglutide, which was non-inferior to liraglutide (difference -0.10%).
In plain wordsIn Japanese patients with type 2 diabetes, liraglutide and once-weekly dulaglutide lowered HbA1c by a similar amount at 26 weeks.
Peptide
Liraglutide
Outcome
No significant changeHbA1c change from baseline at 26 weeks
Study
n: not reported in source
Comparator
Dulaglutide 0.75 mg once weekly
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg once daily · 26 weeksAs given in this study (human).
Measurements
least squares mean difference (dulaglutide vs liraglutide)
−0.1%
26 weeks
Source sentences
Summary
At 26 weeks, once-weekly dulaglutide was superior to placebo and non-inferior to once-daily liraglutide for HbA1c change from baseline [least squares mean difference: dulaglutide vs placebo -1.57% (95% confidence interval -1.79 to -1.35); dulaglutide vs liraglutide -0.10% (95% confidence interval -0.27 to 0.07)].
1 context sentence(design, population, supporting numbers)
Summary · context
This was a phase III, 52-week (26-week primary endpoint), randomized, double-blind, placebo-controlled, open-label comparator (liraglutide) trial comparing 492 Japanese patients with type 2 diabetes (dulaglutide, n = 281; liraglutide, n = 141; and placebo, n = 70) who were aged ≥20 years.
Report a problemFND-2617918701
05HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, nasopharyngitis, constipation, diarrhoea, nausea and abdominal distension did not differ between the dulaglutide and liraglutide groups.
In plain wordsIn Japanese patients with type 2 diabetes, common side effects other than decreased appetite did not differ between liraglutide and dulaglutide.
Peptide
Liraglutide
Outcome
No significant changeOther common adverse events (nasopharyngitis, constipation, diarrhoea, nausea, abdominal distension)
Study
n: not reported in source
Comparator
Dulaglutide 0.75 mg once weekly
Outcome group
Adverse events · Whole body
Studied dose
0.9 mg once dailyAs given in this study (human).
Source sentences
Summary
The most frequently reported adverse events were nasopharyngitis, constipation, diarrhoea, nausea, abdominal distension and decreased appetite; only decreased appetite was different between the dulaglutide and liraglutide groups [dulaglutide, n = 2 (0.7%); liraglutide, n = 8 (5.8%); p = 0.003].
1 context sentence(design, population, supporting numbers)
Summary · context
This was a phase III, 52-week (26-week primary endpoint), randomized, double-blind, placebo-controlled, open-label comparator (liraglutide) trial comparing 492 Japanese patients with type 2 diabetes (dulaglutide, n = 281; liraglutide, n = 141; and placebo, n = 70) who were aged ≥20 years.
Report a problemFND-2617918703
06HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, dulaglutide was non-inferior to liraglutide for HbA1c reduction at 26 weeks.
In plain wordsDulaglutide was non-inferior to liraglutide for long-term blood sugar reduction.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableHbA1c non-inferiority versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 0.9 mg once daily
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg once weekly · 26 weeksAs given in this study (human).
Measurements
HbA1c least squares mean difference
−0.1%
dulaglutide versus liraglutide
95% CI lower
−0.27%
dulaglutide versus liraglutide
95% CI upper
0.07%
dulaglutide versus liraglutide
Source sentences
Summary
At 26 weeks, once-weekly dulaglutide was superior to placebo and non-inferior to once-daily liraglutide for HbA1c change from baseline [least squares mean difference: dulaglutide vs placebo -1.57% (95% confidence interval -1.79 to -1.35); dulaglutide vs liraglutide -0.10% (95% confidence interval -0.27 to 0.07)].
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918706
07HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, nasopharyngitis was frequent and did not differ between dulaglutide and liraglutide groups.
In plain wordsNasopharyngitis was frequent and did not differ between dulaglutide and liraglutide groups.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeNasopharyngitis
Study
n: not reported in source
Comparator
Liraglutide
Outcome group
Adverse events · Respiratory
Studied dose
0.75 mg once weekly · 26 weeksAs given in this study (human).
Source sentences
Summary
The most frequently reported adverse events were nasopharyngitis, constipation, diarrhoea, nausea, abdominal distension and decreased appetite; only decreased appetite was different between the dulaglutide and liraglutide groups [dulaglutide, n = 2 (0.7%); liraglutide, n = 8 (5.8%); p = 0.003].
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918707
08HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, constipation was frequent and did not differ between dulaglutide and liraglutide groups.
In plain wordsConstipation was frequent and did not differ between dulaglutide and liraglutide groups.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeConstipation
Study
n: not reported in source
Comparator
Liraglutide
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg once weekly · 26 weeksAs given in this study (human).
Source sentences
Summary
The most frequently reported adverse events were nasopharyngitis, constipation, diarrhoea, nausea, abdominal distension and decreased appetite; only decreased appetite was different between the dulaglutide and liraglutide groups [dulaglutide, n = 2 (0.7%); liraglutide, n = 8 (5.8%); p = 0.003].
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918708
09HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, diarrhoea was frequent and did not differ between dulaglutide and liraglutide groups.
In plain wordsDiarrhoea was frequent and did not differ between dulaglutide and liraglutide groups.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeDiarrhoea
Study
n: not reported in source
Comparator
Liraglutide
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg once weekly · 26 weeksAs given in this study (human).
Source sentences
Summary
The most frequently reported adverse events were nasopharyngitis, constipation, diarrhoea, nausea, abdominal distension and decreased appetite; only decreased appetite was different between the dulaglutide and liraglutide groups [dulaglutide, n = 2 (0.7%); liraglutide, n = 8 (5.8%); p = 0.003].
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918709
10HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, nausea was frequent and did not differ between dulaglutide and liraglutide groups.
In plain wordsNausea was frequent and did not differ between dulaglutide and liraglutide groups.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeNausea
Study
n: not reported in source
Comparator
Liraglutide
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg once weekly · 26 weeksAs given in this study (human).
Source sentences
Summary
The most frequently reported adverse events were nasopharyngitis, constipation, diarrhoea, nausea, abdominal distension and decreased appetite; only decreased appetite was different between the dulaglutide and liraglutide groups [dulaglutide, n = 2 (0.7%); liraglutide, n = 8 (5.8%); p = 0.003].
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918710
11HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, abdominal distension was frequent and did not differ between dulaglutide and liraglutide groups.
In plain wordsAbdominal distension was frequent and did not differ between dulaglutide and liraglutide groups.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeAbdominal distension
Study
n: not reported in source
Comparator
Liraglutide
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg once weekly · 26 weeksAs given in this study (human).
Source sentences
Summary
The most frequently reported adverse events were nasopharyngitis, constipation, diarrhoea, nausea, abdominal distension and decreased appetite; only decreased appetite was different between the dulaglutide and liraglutide groups [dulaglutide, n = 2 (0.7%); liraglutide, n = 8 (5.8%); p = 0.003].
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918711
12HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, decreased appetite was less frequent with dulaglutide than liraglutide.
In plain wordsDecreased appetite was less frequent with dulaglutide than liraglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseDecreased appetite
Study
n: not reported in source
Comparator
Liraglutide
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Patients with decreased appetite
2 patients
dulaglutide
Decreased appetite incidence
0.7%
dulaglutide
Patients with decreased appetite
8 patients
liraglutide
Decreased appetite incidence
5.8%
liraglutide
Source sentences
Summary
The most frequently reported adverse events were nasopharyngitis, constipation, diarrhoea, nausea, abdominal distension and decreased appetite; only decreased appetite was different between the dulaglutide and liraglutide groups [dulaglutide, n = 2 (0.7%); liraglutide, n = 8 (5.8%); p = 0.003].
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918712
13HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, hypoglycaemia occurred in 2.1% with dulaglutide, 1.5% with liraglutide and 1.4% with placebo; no event was severe.
In plain wordsLow blood sugar occurred in 2.1% with dulaglutide, 1.5% with liraglutide and 1.4% with placebo; none was severe.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableHypoglycaemia
Study
n: not reported in source
Comparator
Liraglutide 0.9 mg once daily and placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Patients with hypoglycaemia
6 patients
dulaglutide
Hypoglycaemia incidence
2.1%
dulaglutide
Patients with hypoglycaemia
2 patients
liraglutide
Hypoglycaemia incidence
1.5%
liraglutide
Patients with hypoglycaemia
1 patients
placebo
Hypoglycaemia incidence
1.4%
placebo
Source sentences
Summary
Nine (1.8%) patients experienced hypoglycaemia [dulaglutide, n = 6 (2.1%); liraglutide, n = 2 (1.5%); placebo, n = 1 (1.4%)], with no event being severe.
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918713
14HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, hypoglycaemia occurred in 2.1% with dulaglutide and 1.4% with placebo.
In plain wordsLow blood sugar occurred in 2.1% with dulaglutide and 1.4% with placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableHypoglycaemia versus placebo
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg once weeklyAs given in this study (human).
Measurements
Patients with hypoglycaemia
6 patients
dulaglutide
Hypoglycaemia incidence
2.1%
dulaglutide
Patients with hypoglycaemia
1 patients
placebo
Hypoglycaemia incidence
1.4%
placebo
Source sentences
Summary
Nine (1.8%) patients experienced hypoglycaemia [dulaglutide, n = 6 (2.1%); liraglutide, n = 2 (1.5%); placebo, n = 1 (1.4%)], with no event being severe.
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918714
15HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes receiving dulaglutide, no hypoglycaemia event was severe.
In plain wordsNo low blood sugar event was severe in patients receiving dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableSevere hypoglycaemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg once weeklyAs given in this study (human).
Source sentences
Summary
Nine (1.8%) patients experienced hypoglycaemia [dulaglutide, n = 6 (2.1%); liraglutide, n = 2 (1.5%); placebo, n = 1 (1.4%)], with no event being severe.
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the efficacy and safety of once-weekly dulaglutide monotherapy (0.75 mg) compared with placebo and once-daily liraglutide (0.9 mg) in Japanese patients with type 2 diabetes.
Summary · context
Analyses were performed on the full analysis set.
Report a problemFND-2617918715

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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.

Versions 4 to 8Current
28 Oct 2026, 02:03 UTC
The same notice was added 5 times, first on 22 Oct 2026, 02:26 UTC. The status did not change between them.
Study results updated
Version 3
21 Oct 2026, 18:59 UTC
Study data updated · source update from Europe PMC
Version 2
12 Oct 2026, 12:10 UTC
Study results updated
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

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Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide is non-inferior to once-daily liraglutide and superior to placebo in Japanese patients with type 2 diabetes: a 26-week randomized phase III study.

Summary

Results from this study15

Version history

Subjects

Publication types

MeSH terms

Keywords