Amylin Pharmaceuticals, a biopharmaceutical company, Eli Lilly and Company and Alkermes, a biotechnology company, have reported positive results from Duration-2, the second in a series of studies designed to test the superiority of exenatide once weekly, an investigational diabetes therapy, as compared to other diabetes medications.
This 26-week clinical study compared exenatide once weekly to maximum doses of sitagliptin or pioglitazone, two commonly prescribed oral diabetes medications, in 491 patients with type 2 diabetes taking stable doses of metformin.
After completing 26 weeks of treatment, evaluable patients randomized to exenatide once weekly experienced a statistically significant reduction in A1C, a measure of average blood sugar over three months, of 1.7% points from baseline, compared to a reduction of 1% point for sitagliptin and 1.4% points for pioglitazone. This finding represents a statistically significant benefit of exenatide once weekly over both sitagliptin and pioglitazone.
Treatment with exenatide once weekly also produced statistically significant differences in weight, with weight loss of 6.2 pounds at 26 weeks, compared with a loss of 1.9 pounds for sitagliptin, and a weight gain of 7.4 pounds for pioglitazone. Over 80% of patients completed the study, and there was one withdrawal due to nausea in each treatment arm.
The 26-week double-blind, superiority study included 491 subjects with type 2 diabetes who were not achieving adequate glucose control using metformin therapy. There was no lead-in or wash-out period. The primary endpoint was reduction in A1C, while secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health and patient-reported outcomes. Subjects were randomized to receive exenatide once weekly 2mg by subcutaneous injection weekly, sitagliptin 100mg daily, or pioglitazone 45mg daily. Subjects in all treatment groups who completed the randomized portion of the study are continuing in an open-ended portion of the study receiving exenatide once weekly.
Amylin, Lilly, and Alkermes are working together to develop exenatide once weekly, a subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes’s technology for long-acting medications.
Jim Malone, global medical director for exenatide at Lilly, said: The results of this study provide us with more insight into the potential profile that may be achieved with exenatide once weekly. As we continue to progress through the series of Duration studies, our goal is to clearly understand how exenatide once weekly compares to other diabetes therapies and be able to articulate, through the data, these differences to patients and their healthcare providers.