Efficacy and safety of adding once‐weekly dulaglutide to basal insulin for inadequately controlled type 2 diabetes in Chinese patients ( AWARD‐CHN3 ): A randomized, double‐blind, placebo‐controlled, phase III trial
Primary result · Change in HbA1c from baselineResult — go to the resultLS mean difference −1.0 % 95% CI −1.1 to −0.8Authors' conclusion
Dulaglutide added to basal insulin was efficacious and well tolerated in Chinese patients with T2DM.
Study context
- Population
- Chinese patients with T2D and HbA1c ≥7.0% and ≤11.0% on stable basal insulin glargine with metformin and/or acarbose
- Participants
- 291 patients
- Comparison
- Add-on once-weekly dulaglutide 1.5 mg vs placebo, on basal insulin glargine
- Primary endpoint
- Superiority of dulaglutide/glargine to placebo/glargine for change from baseline in HbA1c
- Follow-up
- Week 28
Methodological detailsdouble-blind, placebo-controlled, phase III, randomized 1:1
- Double-blind
- Placebo-controlled
- Phase III
- Randomized 1:1
Primary result
Change in HbA1c from baseline
Least squares (LS) mean difference
−1.0 %
95% CI −1.1 to −0.8
P < 0.001
Change by group
Dulaglutide/glargine
−2.0
LS mean · SE 0.08 · %
Placebo/glargine
−1.1
LS mean · SE 0.07 · %
Dulaglutide/glarginevs Placebo/glargine
LS mean difference −1.0 % (95% CI −1.1 to −0.8); P < 0.001
As reported in the abstract
Further findings
HbA1c <7.0%
P < 0.001
| Outcome | LS mean difference (kg) (95% CI) | P value | |
|---|---|---|---|
| Body weight | −1.2 (−1.8 to - 0.6) | P < 0.001 | |
| −2−101Difference, kg (linear scale) |
| Outcome | LS mean difference (mmol/L) (95% CI) | P value | |
|---|---|---|---|
| Fasting serum glucose | −0.8 (−1.1 to - 0.5) | P < 0.001 | |
| −1.5−1−0.500.51Difference, mmol/L (linear scale) |
Body weight
- Body weight decreased with dulaglutide/glargine and increased with placebo/glargine
Safety
Hypoglycaemia
P = 0.704
- Hypoglycaemia — Severe hypoglycaemia, either group
- 0
Most common treatment-emergent adverse events with dulaglutide/glargine
- Decreased appetite
- 22.2%
- Diarrhoea
- 13.2%
- Nausea
- 10.4%
Original publication
Efficacy and safety of adding once‐weekly dulaglutide to basal insulin for inadequately controlled type 2 diabetes in Chinese patients ( AWARD‐CHN3 ): A randomized, double‐blind, placebo‐controlled, phase III trial. Diabetes Obes Metab. Published 21 September 2023. doi:10.
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