In patents with type 2 diabetes, weekly injections with exenatide controlled hemoglobin A1c levels more effectively than did daily glargine over a 3-year period, investigators reported online in Lancet Diabetes & Endocrinology.
The results from the DURATION-3 trial indicated sustained HbA1c improvement in half of patients who received the glucagonlike peptide-1 (GLP-1) receptor agonist exenatide, compared with just over 40% of patients who received daily treatment with the insulin glargine, said Dr. Michaela Diamant of VU University Medical Centre in Amsterdam and her associates.
Furthermore, the exposure-adjusted rate of overall hypoglycemia was three times higher in the glargine group (0.9 events/patient per year) than in patients who received exenatide (0.3 events/patient per year), independent of HbA1c levels, the researchers said.
Dr. Michaela Diamant
"To our knowledge, ours is the longest prospective trial of a long-acting GLP-1 receptor agonist with a comparator group maintained throughout the study duration," said Dr. Diamant. "Our study suggests that GLP-1 receptor agonists could be a viable treatment option in patients for whom insulin is now the treatment of choice."
The open-label, randomized trial enrolled 456 adults with type 2 diabetes who had suboptimal glycemic control (HbA1c 7.1%-11.0%) despite at least 3 months of maximum-tolerated doses of metformin, with or without a sulfonylurea. In addition to their existing oral regimens, patients received either a once-weekly subcutaneous injection of 2 mg exenatide or once-daily glargine titrated to target.
At 3 years, least-squares mean change in HbA1c for patients treated with once-weekly exenatide was –1.01%, compared with –0.81% in patients treated with glargine, for a statistically significant difference of –0.20% (P =.03). Transient gastrointestinal events were more frequent with exenatide, which is typical of GLP-1 receptor agonists, researchers said. Injection-site reactions were also more common in the exenatide group. The rate of serious adverse events was 15% in both groups, the investigators reported (Lancet Diabetes Endocrinol. 2014 [doi:10.1016/S2213-8587(14)70029-4]).
The study was funded by Eli Lilly and by Amylin, a subsidiary of Bristol-Myers Squibb. Dr. Diamant reported having consulted and spoken on behalf of BMS and Eli Lilly without receiving personal compensation. Four authors reported being employed by the companies at the time of the study.