NEW YORK (Reuters Health) – Patients with type 2 diabetes have better glycemic control and less nausea when exenatide is given weekly rather than twice daily, according to the results of a randomized, open-label trial.

Writing in the May issue of the Journal of Clinical Endocrinology and Metabolism, Dr. Thomas Blevins, with Texas Diabetes and Endocrinology in Austin, and colleagues explain that an extended-release formulation of exenatide administered once weekly is under review by regulatory authorities.

In the current trial, 252 type 2 diabetic patients were assigned to treatment with 2 mg extended-release exenatide weekly for 24 weeks, or to 5 mcg exenatide twice-daily for 4 weeks followed by 10 mcg b.i.d. for 20 weeks. Participants self-administered the subcutaneous injections after training.

At baseline, the mean HbA1c was 8.4% and fasting plasma glucose was 171 mg/dL. After 24 weeks, the mean change in HbA1c was significantly greater with weekly exenatide (-1.6%) than with b.i.d. exenatide (-0.9%), according to the report. Similarly, corresponding changes in fasting glucose were -35 mg/dL vs. -12 mg/dL.

Mean body weight declined in both groups; – 2.3 kg and -1.4 kg with weekly and b.i.d. exenatide, respectively — a nonsignificant difference.

Dr. Blevins and colleague note that nausea was the most frequently reported adverse effect, and occurred in 14% of patients on weekly exenatide compared with 35% on the b.i.d. regimen.

Severe hypoglycemia did not occur and mild hypoglycemia was seen only in 9 of 75 patients taking a concomitant sulfonylurea – 5 patients on the weekly regimen and 4 in the b.i.d. group.

The authors note that the open-label design of this study “may have influenced patient expectations and behaviors.” Still, they conclude that continuous GLP-1 receptor agonism with weekly extended-release exenatide results in superior glycemic control, with less nausea, compared with exenatide b.i.d. in patients with type 2 diabetes.

Reference:

DURATION-5: Exenatide Once Weekly Resulted in Greater Improvements in Glycemic Control Compared with Exenatide Twice Daily in Patients with Type 2 Diabetes

J Clin Endocrinol Metab 2011;96.