Efficacy and safety of exenatide once‐weekly vs exenatide twice‐daily in A sian patients with type 2 diabetes mellitus

Aims/Introduction To compare safety and efficacy of the extended‐release formulation exenatide once weekly ( EQW ) vs exenatide twice daily ( EBID ) for 26 weeks in type 2 diabetes patients from C hina, I ndia, J apan, S outh K orea and T aiwan. Materials and Methods A randomized, comparator‐controlled, open‐label study included 681 patients with type 2 diabetes inadequately controlled (hemoglobin A 1c [ H b A 1c ] ≥7 and ≤11%) with oral antihyperglycemic medications ( OAM s). Patients added 2 mg EQW or 10 μg EBID to current OAM s. Safety was re‐evaluated 10 weeks after last treatment. Results EQW was superior to EBID on H b A 1c measures at week 26 (Least‐squares mean treatment difference: −0.31% [95% confidence interval −0.49, −0.14%]). More EQW ‐treated patients achieved target H b A 1c ≤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). Blood glucose 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. Conclusion 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. NCT 00917267).