Abstract
Aims/Introduction: We assessed the long-term (52 weeks) safety and efficacy of exenatide b.i.d. in Japanese patients with type 2 diabetes and suboptimal glycemic control. MATERIALS AND METHODS: Participants completing a 24-week randomized controlled trial of exenatide (5 μg, 10 μg or placebo b.i.d.) were invited to continue in a 28-week open-label extension study (5 μg, n = 64; 10 μg, n = 53). Safety measures included treatment-emergent adverse events (TEAE). Efficacy measures included change from baseline in glycosylated hemoglobin A1c (HbA1c) levels, proportion of participants achieving HbA1c target levels, fasting and seven-point, self-monitored blood glucose concentrations (SMBG), 1,5-anhydroglucitol concentrations, and bodyweight. RESULTS: A total of 60 and 49 participants in the exenatide 5 and 10 μg groups completed the study. The 52-week incidence of TEAE considered by investigators as related to the study drug was 80.6% (58/72) and 88.9% (64/72) in the exenatide 5 and 10 μg groups, respectively. Mild hypoglycemia and nausea were the most common TEAE. Most TEAE occurred during the first 24 weeks. Eight participants experienced serious adverse events. Exenatide treatment was associated with sustained decreases in HbA1c values, with 33.3-47.9% of participants achieving <6.9% HbA1c, sustained decreases in fasting plasma glucose concentrations and SMBG, and sustained increases in 1,5-anhydroglucitol concentrations. Exenatide 10 μg was associated with sustained weight loss. CONCLUSIONS: Long-term exenatide treatment had a similar safety profile to that observed previously and was efficacious in improving glycemic control in Japanese patients with suboptimally controlled type 2 diabetes. This trial was registered with ClinicalTrials.gov (no. NCT00577824). (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00137.x, 2011).