Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has approved Metaglip (glipizide and metformin HCl Tablets) for use, along with diet and exercise, as initial drug therapy for people with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone.
Metaglip was also approved as second-line therapy for patients with type 2 diabetes who are currently taking either metformin or a sulfonylurea with a regimen of diet and exercise, but whose blood sugar levels are inadequately controlled. Metaglip combines glipizide and metformin HCl -- two widely prescribed oral antidiabetic agents -- in a single pill. These agents work in complementary fashion to improve blood sugar in patients with type 2 diabetes.
"As a leader in the field of type 2 diabetes, Bristol-Myers Squibb continues to work to develop new treatment options for the more than 17 million people in the United States with this condition," said Peter R. Dolan, Chairman and CEO, Bristol-Myers Squibb. "Metaglip represents an important new therapeutic choice for the management of type 2 diabetes and is a significant addition to our company's portfolio of oral antidiabetic products, which also includes Glucovance (glyburide and metformin HCl tablets) and Glucophage XR (metformin hydrochloride extended release tablets)."
In clinical trials, Metaglip was shown to be more effective at lowering blood sugar levels than either glipizide or metformin used alone in patients with type 2 diabetes.
Metaglip (glipizide and metformin HCl tablets) will be available in three dosage strengths, including 2.5 milligram/250 milligram (mg) (glipizide/metformin HCl) tablets, 2.5 mg/500 mg tablets, and 5 mg/500 mg tablets.
Metaglip, Glucovance and Glucophage XR are not for everyone. In rare cases these products may cause lactic acidosis (buildup of lactic acid in the blood), which is serious and can be fatal in half the cases. This occurs mainly in people whose kidneys are not functioning properly. Patients should advise their doctor about their alcohol use because this increases the risk. Patients should not take these products if they: have kidney problems, are 80 or older (unless their kidneys are tested), are taking medication for heart failure, are seriously dehydrated, have a serious infection, or have or have had liver disease. The most common side effects are diarrhea, nausea/vomiting, and abdominal pain. Symptoms of hypoglycemia (low blood sugar) such as lightheadedness, dizziness, shakiness, or hunger may also occur with Metaglip and Glucovance.