Efficacy and Safety of Once Weekly Dulaglutide in East Asian Patients with Type 2 Diabetes: Subgroup Analysis by Potential Influential Factors.

INTRODUCTION: This subgroup analysis assessed the efficacy and safety of once weekly dulaglutide 1.5 mg and 0.75 mg in East Asian patients with type 2 diabetes (T2D) stratified by key demographic and baseline characteristics. METHODS: Change from baseline in glycated hemoglobin (HbA1c), fasting blood glucose (FBG) and body weight were analyzed by age (< 60 years, ≥ 60 years), gender (male, female), body weight (< 70 kg, ≥ 70 kg), BMI (< 25 kg/m, ≥ 25 kg/m), duration of diabetes (< 10 years, ≥ 10 years), baseline HbA1c (< 8.5%, ≥ 8.5%) and concomitant oral antihyperglycemic medications (OAMs; metformin only, SU only, metformin + SU) at week 26 and 52 in East Asian patients from the AWARD-CHN2 study. Incidence of gastrointestinal adverse events (GI AEs) and hypoglycemia was evaluated. RESULTS: A total of 422 East Asian patients with T2D were included in this subgroup analysis. At week 26, the reduction of HbA1c and FBG from baseline were similar across subgroups, except that patients with baseline HbA1c ≥ 8.5% had greater HbA1c and FBG reductions than patients with baseline HbA1c < 8.5%. Gender analysis showed HbA1c difference that was not clinically significant. The decrease in body weight varied across different subgroups in both dulaglutide doses; however, the difference was not clinically significant. The incidence of GI AEs and total hypoglycemia was generally similar across subgroups in both doses. A similar trend was observed at week 52 in both dulaglutide doses. CONCLUSIONS: In East Asian patients with T2D, treatment with dulaglutide (1.5 mg and 0.75 mg) demonstrated significant improvements in glycemic control irrespective of all subgroups, except baseline HbA1c, with greater HbA1c and FBG reductions in patients with higher baseline HbA1c. Dulaglutide was well tolerated with a similar safety profile to other GLP-1 receptor agonists. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01648582.