Safety and efficacy of twice-daily exenatide in Taiwanese patients with inadequately controlled type 2 diabetes mellitus.

BACKGROUND/PURPOSE: Exenatide has been predominantly studied in non-Asian populations. The purpose of this study was to investigate the safety and efficacy of twice-daily (BID) exenatide versus placebo in a subpopulation of Taiwanese patients from a larger study on Asian patients. METHODS: Patients unable to achieve glycemic control with metformin alone or metformin in combination with sulfonylurea were randomly assigned to self-administer either 5 μg exenatide or placebo BID for 4 weeks, then 10 μg exenatide or placebo BID for an additional 12 weeks, in addition to their regular oral therapy. RESULTS: Fifty patients from Taiwan were enrolled in this study (54.0% male; age: 50.9 ± 9.4 years; weight: 71.0 ± 11.6 kg; 8.1 ± 1.0% hemoglobin A1c (HbA1c)). The exenatide-treated patients demonstrated a statistically significant greater reduction in HbA1c from baseline to the endpoint (least-squares [LS] mean [95% confidence interval (CI)]: -0.8% [-1.4 - -0.2]; p = 0.009) compared with patients who received placebo (LS mean [95% CI]: -0.1% [-0.7-0.4]) with an LS mean [95% CI] between-group difference of -0.7% (-1.3 - -0.1) (p = 0.025). A statistically significant higher number of exenatide-treated patients achieved HbA1c targets of ≤ 7% (p = 0.020) and ≤ 6.5% (p = 0.021) by the endpoint compared with patients who received placebo. Exenatide-treated patients experienced a statistically significant reduction in weight from baseline to endpoint (exenatide-placebo adjusted mean difference [95% CI]: -1.6 kg [-2.7 - -0.6]; p = 0.004) compared with the placebo group. The symptomatic hypoglycemia rate (mean patient/year ± standard deviation) was higher in exenatide-treated patients (4.86 mean patient/year ± 7.36) than placebo-treated patients (0.27 mean patient/year ± 1.32). Thirteen (50.0%) exenatide-treated patients and nine (37.5%) placebo-treated patients reported one or more treatment-emergent adverse events; nausea was the most frequently reported side effect (exenatide, 4 [15.4%]; placebo, 0 [0.0%]). CONCLUSION: This subgroup analysis of Taiwanese patients was consistent with the overall study results, which showed that exenatide BID is superior to placebo for improving glycemic control in Asian patients with type 2 diabetes who experienced inadequate glycemic control when using oral antidiabetic therapy.