Depomed, Inc. and King Pharmaceuticals, Inc. announced that as they prepare for the launch of Glumetza (metformin hydrochloride extended-release tablets), a new consensus statement was issued from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).
The statement recommends that treatment with metformin be initiated at diagnosis along with lifestyle changes in patients with type 2 diabetes. In the absence of specific contraindications, metformin is recommended because of its effect on glycemia and absence of weight gain, among other benefits. The consensus statement was published in the August 2006 issue of Diabetes Care.
"These new guidelines were created to define a clear pathway of treatment when physicians are managing diabetes, given the many new and existing therapeutic options and combinations available," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "The ADA's recommendation to start treating diabetic patients with metformin at the point of diagnosis prioritizes this agent as a first line of defense in controlling hyperglycemia. In addition, it recognizes that, unfortunately, most people with type 2 diabetes fail to achieve or maintain their metabolic goals utilizing lifestyle interventions alone. Depomed applauds the ADA's move to address this problem with a recommendation for more aggressive treatment to quickly get glycemic levels under control in order to lessen the long-term health complications and costs associated with this disease."
The ADA and EASD recommendation is based on findings from several clinical trials evaluating various treatments for type 2 diabetes. The results of these trials indicate that present-day diabetes management does not result in successful maintenance of glycemia, as measured by HbA1C levels of less than 7%. The study authors thus presented new guidelines and a treatment algorithm recommending the initiation of both lifestyle changes and metformin treatment at diagnosis. The study notes that metformin has been shown to lower HbA1C levels by approximately 1.5 percentage points and that the most common side effects are gastrointestinal in nature.
Dr. Sherwyn Schwartz, Medical Director, Diabetes and Glandular Disease Clinic, commented, "I am encouraged by the new ADA recommendation regarding the use of metformin at diagnosis. When I served as an investigator in a Phase III clinical trial of Glumetza, an extended-release version of metformin, we observed successful maintenance of blood glucose levels and a 97.2% rate of adherence to the therapeutic regimen as prescribed during the open-label follow-on study in which all patients received 2,000 mg of once-daily Glumetza for 24 weeks."
Depomed and King are currently preparing for a launch for Glumetza in the coming weeks. Glumetza is a novel formulation of metformin that uses Depomed's AcuForm drug delivery technology to provide physicians with a new option for helping their type 2 diabetes patients achieve their HbA1C goals.
"Although there are now more options than ever before in the treatment of diabetes, this consensus statement demonstrates that metformin plays a vital role," Dr. Fara added. "We look forward to launching Glumetza with King next month, and we believe it increases the potential of what metformin can offer and will help physicians and patients achieve their glycemic control goals."
Glumetza (metformin hydrochloride extended-release tablets) is indicated alone or in combination with sulfonylurea or insulin as an adjunct to diet and exercise to improve glycemic control in adult patients (18 years and older) with type 2 diabetes. Glumetza may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults.
Glumetza is contraindicated in patients with renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels greater than or equal to 1.5 mg/dL in males and greater than or equal to 1.4 mg/dL in females), known hypersensitivity to metformin HCl, and acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. As with all metformins, there is a warning regarding lactic acidosis with Glumetza due to metformin accumulation during treatment. Lactic acidosis is a rare but potentially fatal occurrence. It may also occur in association with a number of pathophysiologic conditions. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age, especially patients greater than or equal to 80 years of age. In clinical trials of Glumetza combined with a sulfonylurea, the most common side effects included hypoglycemia, diarrhea, and nausea.