Once-Weekly Exenatide Shows Enduring Control of Diabetes: Presented at ADA

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Title: Once-Weekly Exenatide Shows Enduring Control of Diabetes: Presented at ADA
URL: http://www.pslgroup.com/dg/2235DE.htm
Doctor's Guide
June 11, 2008

By Ed Susman

SAN FRANCISCO -- June 11, 2008 -- Diabetes patients treated with exenatide on a once-weekly schedule appear able to continue control of their diabetes for at least 2 years, researchers reported here at the American Diabetes Association (ADA) 68th Scientific Sessions.

"We saw a 2% reduction in glycated haemoglobin (Hb A1C) levels in subjects treated with exenatide once weekly for 52 weeks and for subjects [who] switched from exenatide twice a day to exenatide once a week," said John Buse, MD, PhD, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, and president of the American Diabetes Association.

In an earlier, 30-week study, investigators were able to demonstrate that the once-weekly injection of exenatide resulted in greater improvement in Hb A1C, similar weight loss, and a similar safety profile when compared with treatment twice a day. "No major hypoglycaemia and no minor hypoglycaemia occurred in patients on exenatide unless they were on background treatment with sulfonylurea medication," Dr. Buse said here in an oral late-breaker presentation on June 9.

That safety profile in this trial was extended through 52 weeks, when all of the patients in the trial were taking exenatide once a week.

In reporting results from the Diabetes Therapy Utilization: Researching Changes in A1C, Weight and Other Factors Through Intervention With Exenatide Once Weekly (DURATION-1) study, Dr. Buse explained that 258 patients entered open-label treatment with exenatide once weekly. Patients either switched from twice-a-day exenatide injections to exenatide once weekly for an additional 22 weeks or remained on exenatide once weekly.

Dr. Buse reported on 241 evaluable patients, 120 of whom had started the trial on the once-a-week regimen. The patients in the extension study were nearly evenly divided by gender (55% men); the average age was 56 years.

The once-weekly dose of exenatide was 2 mg; the twice-daily dosing regimen was 10 mcg at each dose.

At the beginning of the trial, when the 2 doses were being compared, there were 295 patients in the trial with an average duration of diabetes of 6.7 years; these subjects had an Hb A1C level of 8.3% at baseline. Fasting glucose levels at baseline were 169 mg/dL. The average patient weight was 225 pounds, with a mean body mass index of 35.

After 52 weeks, the average Hb A1C dropped 2%, and fasting glucose levels dropped 47 mg/dL. The changes attained at 30 weeks were maintained through 52 weeks, Dr. Buse noted, with patients who switched from twice-daily injections to once-a-week injections exhibiting further improvement in Hb A1C -- demonstrating a 0.6% to 0.7% additional decrease in glucose control.

At the end of 52 weeks, 74% of patients had an Hb A1C less than 7%; 54% had an Hb A1C less than 6.5%; and 25% had an Hb A1C less than 6%. Weight loss at the end of the trial was 4.5 kg for patients who started on twice-daily treatment and were switched to once-a-week treatment, and 4.1 kg for those who were on once-a week dosing for the entire year-long study.

"Importantly, the study results also showed that steady-state levels of exenatide may result in improvements in a variety of glucose parameters. If approved, exenatide once weekly may provide patients with a treatment option that is on board 24 hours a day, seven days a week, helping to manage their blood sugar and, secondarily, their weight," Dr. Buse concluded.

Funding for this study was provided by Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; and Alkermes, Inc., which are collaborating in the development of the once-weekly treatment.

[Presentation title: Late-Breaking Clinical Trial: Exenatide Once Weekly Elicits Sustained Glycemic Control and Weight Loss Over 52 Weeks.]

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