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Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study

2008; Elsevier BV; Volume: 372; Issue: 9645 Linguagem: Inglês

10.1016/s0140-6736(08)61206-4

1474-547X

Daniel J. Drucker, John B. Buse, Kristin Taylor, David M. Kendall, Michael Trautmann, Dongliang Zhuang, Lisa A. Porter,

Pancreatic function and diabetes

Summary Background Exenatide is an incretin mimetic that shares glucoregulatory properties with glucagon-like peptide 1 (GLP-1), and improves glycaemic control, with progressive bodyweight reductions, when administered twice a day in patients with type 2 diabetes. We compared the efficacy of a once-weekly formulation of exenatide to that of a twice daily dose. Methods A 30-week, randomised, non-inferiority study compared a long-acting release formulation of exenatide 2 mg administered once weekly to 10 μg exenatide administered twice a day, in 295 patients with type 2 diabetes (haemoglobin A 1c [HbA 1c ] 8·3% [SD 1·0], mean fasting plasma glucose 9 [SD 2] mmol/L, weight 102 [SD 20] kg, diabetes duration 6·7 [SD 5·0] years). The patients were naive to drug therapy, or on one or more oral antidiabetic agents. The primary endpoint was the change in HbA 1c at 30 weeks. This study is registered with ClinicalTrials.gov, number NCT00308139. Findings At 30 weeks, the patients given exenatide once a week had significantly greater changes in HbA 1c than those given exenatide twice a day (−1·9 [SE 0·1%] vs −1·5 [0·1%], 95% CI −0·54% to −0·12%; p=0·0023). A significantly greater proportion of patients receiving treatment once a week versus twice a day achieved target HbA 1c levels of 7·0% or less (77% vs 61% of evaluable patients, p=0·0039). Interpretation Exenatide once weekly resulted in significantly greater improvements in glycaemic control than exenatide given twice a day, with no increased risk of hypoglycaemia and similar reductions in bodyweight. Funding Amylin Pharmaceuticals Inc and Eli Lilly and Company.