Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea

Abstract

Methods: Patients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 μg then 10 μg twice-daily for 4 and 12 weeks, respectively, or placebo. The primary endpoint was baseline to endpoint HbA_1c change. Results: 466 patients (age 54 ± 9 years, weight 68.7 ± 11.2 kg, BMI 26.3 ± 3.3 kg/m², and HbA_1c 8.3 ± 1.1%; mean ± S.D.) were enrolled in the full analysis set. Endpoint HbA_1c reduction (mean [95% CI]) with exenatide was superior to placebo (−1.2 [−1.3, −1.1]% vs. −0.4 [−0.5, −0.2]%, p < 0.001). More exenatide- than placebo-treated patients achieved HbA_1c ≤7% (48% vs. 17%, p < 0.001). At endpoint, weight reduction was greater with exenatide (−1.2 [−1.5, −0.9] kg) than placebo (−0.1 [−0.3, 0.2] kg), p < 0.001. Nausea, generally mild-to-moderate, was the most common adverse event with exenatide (25% vs. 1% with placebo). The incidence of symptomatic hypoglycaemia with exenatide and placebo were 36% and 9%, respectively (p < 0.001). Hypoglycaemia rates (events/patient-year) for patients taking exenatide with MET or MET and SU were 1.8 (0.9, 3.7) and 4.7 (3.5, 6.5), respectively. Conclusion Exenatide treatment improved glycaemic control in Asian patients with T2D and had a similar safety profile as in non-Asian patients.