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.
