April 11, 2014
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DURATION-3: Weekly exenatide shows promise for type 2 diabetes

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A once-weekly injection of the glucagon-like peptide-1 receptor agonist exenatide could yield better HbA1c control and weight loss for patients with type 2 diabetes who have not yet started taking insulin, according to findings published in The Lancet Diabetes & Endocrinology.

“We recorded sustained HbA1c improvement in half the patients given exenatide and in slightly more than two-fifths of those given glargine over 3 years,” the researchers wrote. “Compared with patients given glargine, those receiving exenatide lost rather than gained weight, had a lower incidence of hypoglycaemia, and had improved quality of life.”

The 3-year open-label, randomized DURATION-3 study, conducted by Michaela Diamant, MD, of VU University Center in Amsterdam, and colleagues, looked at 456 patients with type 2 diabetes aged at least 18 years at 72 sites worldwide. The researchers examined change in HbA1c from baseline with a dose of exenatide (Bydureon/Byetta, Amylin) compared with insulin glargine (Lantus, Sanofi-Aventis).

Eligible patients had suboptimum glycemic control despite maximum tolerated doses of metformin alone or with a sulfonylurea for at least 3 months, a stable body weight for at least 3 months and a BMI of 25 to 45. The exenatide cohort (n=233) received once-weekly doses (2 mg subcutaneous injection) and the glargine cohort (n=223) once-daily doses (titrated to target) in addition to their existing oral glucose-lowering regimens.

Throughout the study, results showed lower HbA1c in patients given exenatide than in those given glargine. At 3 years, treatment with exenatide reduced HbA1c by –1.01% vs. –0.81% in the glargine group (least-squares mean difference, –0.2%; 95% CI, –0.39 to –0.02). Certain adverse gastrointestinal events characteristic of GLP-1 receptor agonists were more frequent with exenatide than glargine, including nausea (15% vs. 2%), vomiting (6% vs. 3%) and diarrhea (14% vs. 7%); however, frequency decreased in the exenatide group after 26 weeks, the researchers reported. The exposure-adjusted rate of overall hypoglycemia was three times higher in the glargine group than the exenatide group.

Disclosure: The researchers report receiving funds from Eli Lilly and Amylin Pharmaceuticals, a wholly owned subsidiary of Bristol-Myers Squibb. Please see the study for a full disclosure list.