Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus.

Abstract

To compare safety and efficacy of the extended-release formulation exenatide once weekly (EQW) vs exenatide twice daily (EBID) for 26weeks in type 2 diabetes patients from China, India, Japan, South Korea and Taiwan. A randomized, comparator-controlled, open-label study included 681 patients with type 2 diabetes inadequately controlled (hemoglobin A1c [HbA1c] ≥7 and ≤11%) with oral antihyperglycemic medications (OAMs). Patients added 2mg EQW or 10μg EBID to current OAMs. Safety was re-evaluated 10weeks after last treatment. EQW was superior to EBID on HbA1c measures at week 26 (Least-squares mean treatment difference: -0.31% [95% confidence interval -0.49, -0.14%]). More EQW-treated patients achieved target HbA1c ≤7.0% (P=0.003), ≤6.5% (P<0.001), or ≤6.0% (P=0.003). Fasting serum glucose reductions were greater among EQW-treated patients (P<0.001). Bloodglucose profiles improved in both treatment groups (P<0.001). Weight loss occurred with both treatments, but was greater with EBID. Adverse events (≥10%, either group) were nausea, injection-site induration, dyslipidemia and vomiting. Injection-site induration was more frequent with EQW, whereas nausea, vomiting and hypoglycemia were less frequent. One episode each of major hypoglycemia (EBID) and pancreatitis (EQW) were reported. In this population, EQW and EBID showed efficacious glucose and weight control; safety and tolerability were consistent with observations in non-Asian patients. This trial was registered with ClinicalTrials.gov (no. NCT00917267).