Once-weekly exenatide versus once- or twice-daily insulin detemir

Abstract

OBJECTIVE-This multicenter, open-label, parallel-arm study compared the efficacy and safety of exenatide once weekly (EQW) with titrated insulin detemir in patients with type 2 diabetes inadequately controlled with metformin (with or without sulfonylureas). RESEARCH DESIGN ANDMETHODS-Patients were randomized to EQW (2 mg) or detemir (once or twice daily, titrated to achieve fasting plasma glucose ≤5.5 mmol/L) for 26 weeks. The primary outcome was proportion of patients achieving A1C $le;7.0% and weight loss ≥1.0 kg at end point, analyzed by means of logistic regression. Secondary outcomes included measures of glycemic control, cardiovascular risk factors, and safety and tolerability. RESULTS-Of 216 patients (intent-to-treat population), 111 received EQWand 105 received detemir. Overall, 44.1% (95% CI, 34.7-53.9) of EQW-treated patients compared with 11.4% (6.0-19.1) of detemir-treated patients achieved the primary outcome (P < 0.0001). Treatment with EQWresulted in significantly greater reductions than detemir in A1C (least-square mean ±SE, -1.30±0.08%vs. -0.88±0.08%; P < 0.0001) and weight (-2.7±0.3 kg vs. +0.8±0.4 kg; P < 0.0001). Gastrointestinal- related and injection site-related adverse events occurredmore frequently with EQWthan with detemir. There was nomajor hypoglycemia in either group. Five (6%) patients in the EQW group and six (7%) patients in the detemir group experienced minor hypoglycemia; only one event occurred without concomitant sulfonylureas (detemir group). CONCLUSIONS-Treatment with EQW resulted in a significantly greater proportion of patients achieving target A1C and weight loss than treatment with detemir, with a low risk of hypoglycemia. These results suggest that EQWis a viable alternative to insulin detemir treatment in patients with type 2 diabetes with inadequate glycemic control using oral antidiabetes drugs. © 2013 by the American Diabetes Association.