Once-Monthly Exenatide Improved Glucose Control in Patients with Type 2 Diabetes: Phase 2 Study Results Presented at ADA 2011
Majority of Patients Reached the ADA Treatment Target for Glycemic Control
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Press Release Source: Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc. On Friday June 24, 2011, 5:00 pm EDT
SAN DIEGO, June 24, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN - News), Eli Lilly and Company (NYSE:LLY - News) and Alkermes, Inc. (Nasdaq:ALKS - News) today announced additional results from a phase 2 study of an investigational, once-monthly injectable suspension formulation of exenatide which showed substantial improvements in glycemic control, including reductions in A1C and fasting plasma glucose, with modest weight loss. These findings will be presented in a late breaking poster session at the 71st Scientific Sessions of the American Diabetes Association on Sunday, June 26 from 12-2 p.m. PDT.
The 121-patient study assessed the efficacy, safety and tolerability of three different doses (5 mg, 8 mg and 11 mg) of exenatide once monthly, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist. After 20 weeks of treatment (total of five injections), patients receiving exenatide once monthly experienced average improvements in A1C (a measure of average blood sugar over three months) from baseline of 1.3 percentage points for the 5 mg and 8 mg doses and 1.5 percentage points for the 11 mg dose. In addition, 50 percent of those treated with the 5 mg dose, 57 percent treated with the 8 mg dose and 70 percent treated with the 11 mg dose achieved an A1C of less than 7 percent, the ADA-recommended target for good glucose control. Patients also lost a modest amount of weight (0.9 pounds with the 8 mg dose and 2.4 pounds with the 5 mg and 11 mg doses), although exenatide once monthly is not being studied as a weight-loss product. Fasting plasma glucose was improved with all doses, with reductions of 25 mg/dL with the 5 mg dose, 30 mg/dL with the 8 mg dose and 49 mg/dL with the 11 mg dose. The mean pharmacokinetic profile showed all three exenatide once monthly doses resulted in steady-state exenatide plasma levels within the known therapeutic range.
As a reference arm, the study also included patients receiving BYDUREON™ (exenatide extended-release for injectable suspension), another investigational form of exenatide that is dosed once-weekly. Results for A1C, fasting glucose and weight in the exenatide once monthly treatment arms were generally comparable to those seen in the BYDUREON reference arm. Patients receiving BYDUREON experienced reductions in A1C (1.5 percentage points), fasting plasma glucose (34 mg/dL) and weight (3.1 pounds) compared to baseline.
"Our exenatide suspension program builds upon our extensive experience and knowledge gained throughout the development of BYETTA and BYDUREON, and suggests promise in harnessing the therapeutic potential of continuous GLP-1 agonism in a monthly dose," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "We are committed to expanding the treatment options available to patients living with type 2 diabetes through the continued investigation of additional formulations of exenatide."
More than 90 percent of patients completed the study. The most common adverse events within the exenatide once monthly treatment groups were headache (17-27 percent) and nausea (17-23 percent). Headache (30 percent) and diarrhea (27 percent) were most common among the BYDUREON group. No major or minor hypoglycemia was reported in the study. The duration of adverse events was generally similar between treatment groups.
Exenatide once monthly is an investigational, extended-release formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which is given twice daily. Exenatide once monthly is based on the same microsphere technology used in BYDUREON. BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension, an investigational medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON received marketing authorization in the European Union earlier this month.
Study Design
This phase 2, randomized, open-label, dose-ranging study included 121 adults with type 2 diabetes (baseline A1C: 8.6 percent for BYDUREON and 8.4-8.5 percent for exenatide once monthly) who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, Actos® (pioglitazone) or both. Subjects were randomized to receive either 2 mg weekly subcutaneous injections of BYDUREON or subcutaneous injections of exenatide once monthly at a low (5 mg), medium (8 mg) or high (11 mg) dose administered once every four weeks for 20 weeks.
About Diabetes
Diabetes affects nearly 26 million people in the U.S. and an estimated 285 million adults worldwide.(i)(ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs more than $174 billion per year in direct and indirect medical expenses.(iii)
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi)(vii)
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