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

Aims: To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents. Methods: Patients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 mu g then 10 mu g 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 +/- 1.1.2 kg, BMI 26.3 +/- 3.3 kg/m(2), 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. (C) 2008 Elsevier Ireland Ltd. All rights reserved.