Objective: To evaluate the efficacy of dulaglutide (1.5mg, 0.75mg) in Chinese T2DM patients with baseline BMI <25 kg/m2 or ≥25 kg/m2, a post hoc analysis was conducted on two randomized trials at week 26.
Methods: Patients in the dulaglutide versus glimepiride study (AWARD-CHN1, NCT01644500; n=555) were treatment-naive or discontinued from oral monotherapy; those in the dulaglutide versus glargine study (AWARD-CHN2, NCT01648582; n=591) continued on metformin and/or sulfonylurea. Analyses were conducted based on mixed-model repeated measures using modified intent-to-treat analysis set with only Chinese population. HbA1change from baseline was analyzed by individual study.
Results: Overall, 45.6% of patients in AWARD-CHN1 and 42.8% in AWARD-CHN2 had a baseline BMI <25 kg/m2. In patients with BMI<25 kg/m2 or ≥25 kg/m2 of AWARD-CHN1, both doses of dulaglutide were superior to glimepiride for HbA1c reduction from baseline with a least squares mean difference of -0.55% or -0.53% for dulaglutide 1.5mg (both P<0.001) and -0.32% or -0.35% for dulaglutide 0.75mg (both P<0.05). In AWARD-CHN2, dulaglutide 1.5mg was superior to glargine for HbA1c reduction from baseline with a least squares mean difference of -0.58% or -0.55% in patients with BMI<25 kg/m2 or ≥25 kg/m2 of (both P<0.001), while dulaglutide 0.75mg was superior to glargine for HbA1c reduction from baseline with that difference of -0.29% in patients with BMI<25 kg/m2 (P<0.05), but non-inferior to glargine for HbA1c reduction from baseline with that difference of -0.16% in patients with BMI ≥25 kg/m2.
Conclusions: Irrespective of baseline BMI, Dulaglutide showed effective HbA1c reduction in Chinese T2DM patients compared with glimepiride and glargine. For higher BMI patients treated with oral anti-hyperglycemia medicine, dulaglutide 1.5mg could be a better clinical choice.
Y. Shi: None. B. Zhang: Employee; Self; Eli Lilly and Company. H. Wu: Employee; Self; Eli Lilly and Company.