Promising Results For Once Weekly Diabetes Drug Exenatide

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Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 11 Sep 2008 - 0:00 PDT

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New research published early online and in an upcoming edition of The Lancet reports on a new formulation of the diabetes drug exenatide. Dr Daniel Drucker (Mount Sinai Hospital and University of Toronto, Ontario, Canada) and colleagues maintain that the new drug, given only once weekly, is better for controlling blood sugar and more convenient to manage than the current regimen that must be taken twice daily. An announcement of these findings will also take place at The European Association for the Study of Diabetes meeting in Rome.

Exenatide is a drug designed for type 2 diabetes patients that improves blood sugar control and helps them lose weight. Dr. Drucker and colleagues conducted a randomized trial with 259 patients to test for differences between the old exenatide regimen and the new formulation. Patients were randomly assigned such that 129 received the new long-acting release formulation (2 mg exenatide given once weekly) and 130 patients received the old regimen (10 μg exenatide, twice daily). At baseline, the mean weight of patients was 102 kg (225 lbs.) and the average patient had diabetes for about seven years. Blood sugar control was measured by hemoglobin A1c (HbA1c) levels in the blood, which was about 8.3%, on average, before exenatide administration. Healthy people usually have HbA1c levels between 4.0% and 6.0%.

The results of the study favored the new exenatide formulation. Patients on the new regimen had an HbA1c level decrease of about 1.9% to a mean of 6.4% compared to the group on the old regimen that had an HbA1c level decrease of about 1.5% to a mean of 6.8%. Seventy-seven percent of patients taking the new once-weekly formulation met the target HbA1c level of 7.0%, whereas 61% of the twice-daily patients did. There was little difference between the two groups, however, in the proportions of patients achieving HbA1c levels of 6.5% or less or 6.0% or less. "Exenatide once weekly resulted in significantly greater improvements in glycemic control than exenatide given twice a day, with no increased risk of hypoglycemia and similar reductions in bodyweight," conclude the researchers.

An accompanying comment written by Dr André Scheen (University of Liège, Belgium) notes that, "Compared with the twice-a-day exenatide regimen, the once-a-week formulation, besides obvious improved ease of use, provided the remarkable advantage of both improved efficacy on glucose control and good gastrointestinal tolerability." If these findings are confirmed and extended, writes Dr. Scheen, management of type 2 diabetes could be changed substantially.

Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study
Daniel J Drucker, John B Buse, Kristin Taylor, David M Kendall, Michael Trautmann, Dongliang Zhuang, Lisa Porter, for the DURATION-1 Study Group
The Lancet (2008).
DOI:10.1016/S0140-6736(08)61206-4
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Written by: Peter M Crosta
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