Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.
This 26-week clinical study compared BYDUREON monotherapy to Januvia (sitagliptin), Actos (pioglitazone HCI) or metformin, three oral type 2 diabetes medications commonly prescribed early in the treatment of type 2 diabetes. Study participants were not achieving adequate A1C control using diet and exercise, and were not on any diabetes therapy when they entered the study. A1C is a measure of average blood sugar over three months. After 26 weeks of treatment, patients randomized to BYDUREON experienced a reduction in A1C of 1.5 percentage points from baseline, which was significantly greater than the reduction of 1.2 percentage points for Januvia. Patients randomized to metformin experienced a reduction in A1C of 1.5 percentage points, and patients receiving Actos experienced a reduction of 1.6 percentage points. Patients receiving BYDUREON, Actos and metformin treatment achieved an average A1C of less than 7 per cent by study end.
Treatment with BYDUREON produced an average weight loss of 4.5 pounds, which was statistically significantly greater than the average 1.7 pounds patients lost with Januvia and the average 3.3 pounds patients gained with Actos. Patients receiving metformin experienced an average weight loss of 4.4 pounds.
"The majority of patients in this study reached an optimal A1C goal of less than seven per cent, which is the glucose control target recommended by the American Diabetes Association," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "DURATION-4 reinforced that continued presence of exenatide helped these recently diagnosed patients to achieve glycemic control. The combination of efficacy, tolerability, and once weekly dosing in this monotherapy setting further supports the potential role BYDUREON can play in helping patients and physicians manage type 2 diabetes."
More than 80 per cent of patients in all treatment arms completed the study. There were no major hypoglycemia events in any treatment group. The most frequently reported adverse events among BYDUREON users were nausea (withdrawal rate less than 1 percent) and diarrhoea; metformin, diarrhoea and headache; Actos, upper respiratory tract infection, headache, hypertension and peripheral edema; and Januvia, upper respiratory tract infection and headache.
BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA(R) (exenatide) injection, which has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 per cent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen. In addition, 85 per cent of type 2 diabetes patients are overweight and 55 per cent are considered obese. Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.
BYETTA is the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.
BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.
BYETTA provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, with potential weight loss. BYETTA is not a weight-loss product. BYETTA was approved in April 2005 and has been used by more than one million patients since its introduction.
Amylin, Lilly and Alkermes are working together to develop BYDUREON, a subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes' proprietary Medisorb technology for long-acting medications. BYDUREON is not currently approved by any regulatory agencies.