A randomized, double‐blind trial assessing the efficacy and safety of two doses of dulaglutide in Japanese participants with type 2 diabetes ( AWARD‐JPN )
Primary result · Change in HbA1c from baselineResult — go to the resultLSM difference −0.29 % 95% CI −0.43 to −0.14Authors' conclusion
Dulaglutide 1.5 mg once weekly demonstrated superior glycaemic control versus dulaglutide 0.75 mg once weekly, with comparable safety and tolerability, in Japanese people with T2D.
Study context
- Population
- Japanese adults aged ≥20 years with T2D for ≥6 months and inadequate glycaemic control on a single oral antihyperglycaemic medicationrandomized
- Participants
- 591 adults
- Comparison
- Once-weekly dulaglutide 1.5 mg vs dulaglutide 0.75 mg
- Primary endpoint
- Mean change in HbA1c from baseline (superiority of 1.5 mg vs 0.75 mg)
- Follow-up
- 26 weeks
Methodological detailsphase 3, multicentre, double-blind, parallel-group
- Phase 3
- Multicentre
- Double-blind
- Parallel-group
Primary result
Change in HbA1c from baseline · Week 26
LSM difference
−0.29 %
95% CI −0.43 to −0.14
Dulaglutide 1.5 mgvs Dulaglutide 0.75 mg
LSM difference −0.29 % (95% CI −0.43 to −0.14)
As reported in the abstract
Further findings
HbA1c <7.0% · Week 52
P = 0.03
| Outcome | LSM difference (mg/dL) (95% CI) | P value | |
|---|---|---|---|
| Change in fasting serum glucose · Week 52Greater reduction with 1.5 mg | −9.4 (−14.4 to −4.3) | P < 0.001 | |
| −20−10010Difference, mg/dL (linear scale) |
Body weight
- No statistically significant change in body weight in either arm
Safety
- Participants with treatment emergent adverse events (TEAEs) (overall)
- 442 (75.4%)
- Constipation
- 11.3%
- Diarrhoea
- 9.6%
- Pyrexia
- 9.0%
Original publication
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 Obes Metab. Published 7 May 2024. doi:10.
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