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Randomized Controlled Trial
.2008 Oct 4;372(9645):1240-50.
doi: 10.1016/S0140-6736(08)61206-4. Epub 2008 Sep 7.

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

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Randomized Controlled Trial

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

Daniel J Drucker et al. Lancet..

Abstract

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 mug 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, numberNCT00308139.

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.

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Comment in

  • Exenatide once weekly in type 2 diabetes.
    Scheen AJ.Scheen AJ.Lancet. 2008 Oct 4;372(9645):1197-8. doi: 10.1016/S0140-6736(08)61207-6. Epub 2008 Sep 7.Lancet. 2008.PMID:18782642No abstract available.
  • Exenatide for type 2 diabetes.
    Garattini S, Bertele' V, Floriani I, Torri V.Garattini S, et al.Lancet. 2009 Jan 10;373(9658):122; author reply 122-3. doi: 10.1016/S0140-6736(09)60034-9.Lancet. 2009.PMID:19135608No abstract available.

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