Dulaglutide 1.5 mg once weekly was superior to 0.75 mg for reducing HbA1c in Japanese patients with type 2 diabetes, with comparable safety profiles.
−0.29% HbA1c advantage for 1.5 mgDulaglutide 1.5 mg showed statistically superior glycemic control versus 0.75 mg at 26 weeks in Japanese T2D patients (AWARD-JPN trial)
What the researchers found
At 26 weeks, dulaglutide 1.5 mg was statistically superior to 0.75 mg for HbA1c reduction (LSM difference -0.29%, 95% CI: -0.43 to -0.14). At 52 weeks, the higher dose showed a significantly greater proportion reaching HbA1c <7.0% (46.3% vs 38.5%, p = 0.03) and greater fasting glucose reduction (LSM difference -9.4 mg/dL, 95% CI: -14.4 to -4.3, p < 0.001).
No statistically significant body weight change was observed in either arm. The most common adverse events were constipation (11.3%), diarrhea (9.6%), and fever (9.0%). Overall, 75.4% of participants experienced at least one treatment-emergent adverse event.
Why it matters
This trial establishes the benefit of the higher dulaglutide dose specifically for Japanese patients, who may respond differently to GLP-1 agonists due to differences in body composition, beta cell function, and diabetes pathophysiology compared to Western populations. The AWARD-JPN trial provides the evidence base needed for dosing recommendations in Japan's large type 2 diabetes population.
How the study worked
Phase 3, multicenter, randomized, double-blind, parallel-group study (AWARD-JPN, NCT04809220). 591 Japanese adults aged ≥20 with T2D for ≥6 months and inadequate glycemic control on a single oral medication were randomized to once-weekly dulaglutide 1.5 mg or 0.75 mg. Primary endpoint: mean HbA1c change at 26 weeks. Secondary endpoints assessed at 26 and 52 weeks. Intention-to-treat analysis.
What this study cannot tell us
The study compared two doses of the same drug without a placebo arm, limiting conclusions about absolute efficacy. The absence of weight loss in both arms is unexplained and differs from Western dulaglutide trials. The study population was exclusively Japanese, limiting generalizability to other Asian or non-Asian populations. Duration was 52 weeks — longer-term data would be valuable. Participants were on a single oral antidiabetic drug at baseline, so results may not apply to those on more complex regimens.
How to read the evidence
This is a Phase 3, multicenter, randomized, double-blind trial published in Diabetes, Obesity & Metabolism. The methodology is rigorous with appropriate randomization and blinding, though the lack of a placebo arm and focus on a single population limits broader conclusions.
When this study was published
Published in 2024, this is a recent trial providing population-specific data for dulaglutide dosing in Japanese patients with type 2 diabetes.
The bigger picture
GLP-1 receptor agonist dose optimization across populations is an important area of research. East Asian patients with type 2 diabetes tend to have lower BMI but greater beta cell dysfunction compared to Western patients. The absence of weight loss in this Japanese cohort — despite improved glycemic control — contrasts with Western trials and highlights population-specific drug responses that affect clinical decision-making.
Questions still open
- Why did neither dulaglutide dose produce significant weight loss in Japanese patients, unlike Western trial populations?
- Would a higher dose beyond 1.5 mg provide additional benefit in Japanese T2D patients without compromising tolerability?
- How does dulaglutide's efficacy in Japanese patients compare with semaglutide and tirzepatide in the same population?
Common questions
What is dulaglutide and how is it different from semaglutide?
Why was this trial specific to Japanese patients?
Read the original research
A randomized, double-blind trial assessing the efficacy and safety of two doses of dulaglutide in Japanese participants with type 2 diabetes (AWARD-JPN).
Diabetes, obesity & metabolism, 26(8), 3167-3175
Citation
Morioka, Tomoaki; Takeuchi, Masakazu; Ozeki, Akichika; Emoto, Masanori. (2024). A randomized, double-blind trial assessing the efficacy and safety of two doses of dulaglutide in Japanese participants with type 2 diabetes (AWARD-JPN).. Diabetes, obesity & metabolism, 26(8), 3167-3175. https://doi.org/10.1111/dom.15644