A randomized, double-blind trial assessing the efficacy and safety of two doses of dulaglutide in Japanese participants with type 2 diabetes (AWARD-JPN).

Morioka T, Takeuchi M, Ozeki A, Emoto M

Diabetes, obesity & metabolism7 May 2024

PMID38715179DOI10.1111/dom.15644PepBankPUB-38715179

Publisher page PubMedAsk about this study

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. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese adults with diabetes, dulaglutide 1.5 mg reduced HbA1c more than 0.75 mg at week 26.
In plain wordsIn Japanese adults with diabetes, dulaglutide 1.5 mg reduced HbA1c more than 0.75 mg at week 26.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c reduction at week 26
Study
n = 591
Comparator
Dulaglutide 0.75 mg once weekly
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
HbA1c least squares mean difference
−0.29%
1.5 mg versus 0.75 mg at week 26
HbA1c least squares mean difference 95% CI
−0.43 to −0.14%
1.5 mg versus 0.75 mg at week 26
Source sentences
Summary
At Week 26, dulaglutide 1.5 mg was superior to dulaglutide 0.75 mg in HbA1c reduction from baseline (least squares mean [LSM] difference -0.29% [95% confidence interval {CI} -0.43, -0.14]).
2 context sentences(design, population, supporting numbers)
Summary · context
A Phase 3, multicentre, randomized, double-blind, parallel-group study was conducted in Japanese participants aged ≥20 years, with T2D for ≥6 months and inadequate glycaemic control, while on a single oral antihyperglycaemic medication (NCT04809220).
Summary · context
All statistical analyses were conducted using the intention-to-treat population.
Report a problemFND-3871517901
02HumanRandomized controlled trialEfficacy outcome
In Japanese adults with diabetes, more participants reached HbA1c below 7.0% with dulaglutide 1.5 mg than 0.75 mg.
In plain wordsIn Japanese adults with diabetes, more participants reached HbA1c below 7.0% with dulaglutide 1.5 mg than 0.75 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c below target at week 52
Study
n = 591
Comparator
Dulaglutide 0.75 mg once weekly
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · 52 weeksAs given in this study (human).
Measurements
Target attainment
46.3%
dulaglutide 1.5 mg at week 52
Target attainment
38.5%
dulaglutide 0.75 mg at week 52
Source sentences
Summary
At Week 52, the dulaglutide 1.5-mg arm had a significantly greater proportion of participants who achieved HbA1c <7.0% (46.3% vs. 38.5%; p = 0.03)
2 context sentences(design, population, supporting numbers)
Summary · context
A Phase 3, multicentre, randomized, double-blind, parallel-group study was conducted in Japanese participants aged ≥20 years, with T2D for ≥6 months and inadequate glycaemic control, while on a single oral antihyperglycaemic medication (NCT04809220).
Summary · context
All statistical analyses were conducted using the intention-to-treat population.
Report a problemFND-3871517902
03HumanRandomized controlled trialEfficacy outcome
In Japanese adults with diabetes, dulaglutide 1.5 mg reduced fasting serum glucose more than 0.75 mg at week 52.
In plain wordsIn Japanese adults with diabetes, dulaglutide 1.5 mg reduced fasting serum glucose more than 0.75 mg at week 52.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseFasting serum glucose at week 52
Study
n = 591
Comparator
Dulaglutide 0.75 mg once weekly
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · 52 weeksAs given in this study (human).
Measurements
Fasting serum glucose least squares mean difference
−9.4 mg/dL
1.5 mg versus 0.75 mg at week 52
Fasting serum glucose least squares mean difference 95% CI
−14.4 to −4.3 mg/dL
1.5 mg versus 0.75 mg at week 52
Source sentences
Summary
and showed significantly greater reduction in fasting serum glucose (LSM difference -9.4 mg/dL [95% CI -14.4, -4.3]; p < 0.001) versus the dulaglutide 0.75-mg arm.
2 context sentences(design, population, supporting numbers)
Summary · context
A Phase 3, multicentre, randomized, double-blind, parallel-group study was conducted in Japanese participants aged ≥20 years, with T2D for ≥6 months and inadequate glycaemic control, while on a single oral antihyperglycaemic medication (NCT04809220).
Summary · context
All statistical analyses were conducted using the intention-to-treat population.
Report a problemFND-3871517903
04HumanRandomized controlled trialEfficacy outcome
In Japanese adults with diabetes, body weight did not change significantly with dulaglutide 1.5 mg.
In plain wordsIn Japanese adults with diabetes, body weight did not change significantly from baseline with dulaglutide 1.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeBody weight at 1.5 mg
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
1.5 mg once weeklyAs given in this study (human).
Source sentences
Summary
No statistically significant change in body weight was observed in either treatment arm.
3 context sentences(design, population, supporting numbers)
Summary · context
Overall, 591 participants were randomized to once-weekly dulaglutide 1.5 mg or 0.75 mg.
Summary · context
A Phase 3, multicentre, randomized, double-blind, parallel-group study was conducted in Japanese participants aged ≥20 years, with T2D for ≥6 months and inadequate glycaemic control, while on a single oral antihyperglycaemic medication (NCT04809220).
Summary · context
All statistical analyses were conducted using the intention-to-treat population.
Report a problemFND-3871517904
05HumanRandomized controlled trialEfficacy outcome
In Japanese adults with diabetes, body weight did not change significantly with dulaglutide 0.75 mg.
In plain wordsIn Japanese adults with diabetes, body weight did not change significantly from baseline with dulaglutide 0.75 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeBody weight at 0.75 mg
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg once weeklyAs given in this study (human).
Source sentences
Summary
No statistically significant change in body weight was observed in either treatment arm.
3 context sentences(design, population, supporting numbers)
Summary · context
Overall, 591 participants were randomized to once-weekly dulaglutide 1.5 mg or 0.75 mg.
Summary · context
A Phase 3, multicentre, randomized, double-blind, parallel-group study was conducted in Japanese participants aged ≥20 years, with T2D for ≥6 months and inadequate glycaemic control, while on a single oral antihyperglycaemic medication (NCT04809220).
Summary · context
All statistical analyses were conducted using the intention-to-treat population.
Report a problemFND-3871517905
06HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, 75.4% receiving either dulaglutide dose experienced treatment-emergent adverse events.
In plain wordsIn Japanese adults with diabetes, 75.4% receiving either dulaglutide dose experienced treatment-emergent adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedTreatment-emergent adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
1.5 mg or 0.75 mg once weeklyAs given in this study (human).
Measurements
Participants with treatment-emergent adverse events
75.4%
either dulaglutide dose, overall
Participants with treatment-emergent adverse events
442 participants
either dulaglutide dose, overall
Source sentences
Summary
Overall, 442 participants (75.4%) experienced treatment emergent adverse events (TEAEs).
2 context sentences(design, population, supporting numbers)
Summary · context
A Phase 3, multicentre, randomized, double-blind, parallel-group study was conducted in Japanese participants aged ≥20 years, with T2D for ≥6 months and inadequate glycaemic control, while on a single oral antihyperglycaemic medication (NCT04809220).
Summary · context
All statistical analyses were conducted using the intention-to-treat population.
Report a problemFND-3871517906
07HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes receiving either dulaglutide dose, constipation occurred in 11.3%.
In plain wordsIn Japanese adults with diabetes receiving either dulaglutide dose, constipation occurred in 11.3%.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedConstipation
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg or 0.75 mg once weeklyAs given in this study (human).
Measurements
Constipation incidence
11.3%
either dulaglutide dose, overall
Source sentences
Summary
Constipation (11.3%), diarrhoea (9.6%) and pyrexia (9.0%) were the most commonly reported TEAEs.
2 context sentences(design, population, supporting numbers)
Summary · context
A Phase 3, multicentre, randomized, double-blind, parallel-group study was conducted in Japanese participants aged ≥20 years, with T2D for ≥6 months and inadequate glycaemic control, while on a single oral antihyperglycaemic medication (NCT04809220).
Summary · context
All statistical analyses were conducted using the intention-to-treat population.
Report a problemFND-3871517907
08HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes receiving either dulaglutide dose, diarrhoea occurred in 9.6%.
In plain wordsIn Japanese adults with diabetes receiving either dulaglutide dose, diarrhoea occurred in 9.6%.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedDiarrhoea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg or 0.75 mg once weeklyAs given in this study (human).
Measurements
Diarrhoea incidence
9.6%
either dulaglutide dose, overall
Source sentences
Summary
Constipation (11.3%), diarrhoea (9.6%) and pyrexia (9.0%) were the most commonly reported TEAEs.
2 context sentences(design, population, supporting numbers)
Summary · context
A Phase 3, multicentre, randomized, double-blind, parallel-group study was conducted in Japanese participants aged ≥20 years, with T2D for ≥6 months and inadequate glycaemic control, while on a single oral antihyperglycaemic medication (NCT04809220).
Summary · context
All statistical analyses were conducted using the intention-to-treat population.
Report a problemFND-3871517908
09HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes receiving either dulaglutide dose, pyrexia occurred in 9.0%.
In plain wordsIn Japanese adults with diabetes receiving either dulaglutide dose, fever occurred in 9.0%.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedPyrexia
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
1.5 mg or 0.75 mg once weeklyAs given in this study (human).
Measurements
Pyrexia incidence
9%
either dulaglutide dose, overall
Source sentences
Summary
Constipation (11.3%), diarrhoea (9.6%) and pyrexia (9.0%) were the most commonly reported TEAEs.
2 context sentences(design, population, supporting numbers)
Summary · context
A Phase 3, multicentre, randomized, double-blind, parallel-group study was conducted in Japanese participants aged ≥20 years, with T2D for ≥6 months and inadequate glycaemic control, while on a single oral antihyperglycaemic medication (NCT04809220).
Summary · context
All statistical analyses were conducted using the intention-to-treat population.
Report a problemFND-3871517909

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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A randomized, double-blind trial assessing the efficacy and safety of two doses of dulaglutide in Japanese participants with type 2 diabetes (AWARD-JPN).

Summary

Results from this study9

Version history

Subjects

Publication types

MeSH terms

Keywords