Amylin Pharmaceuticals, Inc, Eli Lilly and Company and Alkermes, Inc announced 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 percentage points from baseline, compared to a reduction of 1.0 percentage point for sitagliptin and 1.4 percentage 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.
"Recognizing the importance of A1C control, it has become clear that health care providers need comparative data to better understand the relative value of therapeutic options," said Richard Bergenstal, executive director of the International Diabetes Center. "A once-weekly therapy that helps patients achieve A1C targets, with the added benefits of weight loss and no major hypoglycaemia, could provide patients with an important option to improve their diabetes care."
"Together with our collaboration partners Lilly and Alkermes, we are pleased that exenatide once weekly met the primary endpoint of this superiority study and showed greater reduction in A1C than sitagliptin or pioglitazone. Additionally, from an average baseline of 193 pounds, at the end of the study patients on exenatide once weekly weighed an average of 14 pounds less than patients on pioglitazone and 4 pounds less than patients on sitagliptin," stated Orville G Kolterman, senior vice president of research and development at Amylin Pharmaceuticals. "These data continue to build the value proposition for a once-weekly treatment that, if approved, has the potential to help patients improve their diabetes management."
"The results of this study provide us with more insight into the potential profile that may be achieved with exenatide once weekly," said Dr Jim Malone, global medical director for exenatide, Eli Lilly and Company. "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."
Over 80 per cent of patients completed the study, and there was one withdrawal due to nausea in each treatment arm. There was no major hypoglycaemia in any treatment group. The most frequently reported adverse events among exenatide once weekly and sitagliptin users were nausea and diarrhoea. Upper respiratory tract infection and peripheral edema were the most frequently reported events by patients receiving pioglitazone.
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' proprietary technology for long-acting medications. Exenatide once weekly is not currently approved by any regulatory agencies.