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FDA Approves Eli Lilly Diabetes Combo Drug Jentadueto

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced the FDA approved Jentadueto™ (linagliptin/metformin hydrochloride) tablets….

Drawing from the momentum of Tradjenta™ (linagliptin) tablets — approved for U.S. marketing in May 2011 – JENTADUETO combines linagliptin and metformin into a new, single-tablet option, taken twice daily and comes in 3 different dosages.

JENTADUETO is a prescription medication used along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate. JENTADUETO is not for the treatment of type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.

At the maximum dose, JENTADUETO demonstrated placebo-corrected reductions in hemoglobin A1Clevels of up to 1.7 percent. It can be used alone or in combination with a sulfonylurea, another commonly prescribed medication for type 2 diabetes.

The JENTADUETO label contains a boxed warning because the addition of metformin which may cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. It is not for treatment of type 1 diabetes or diabetic ketoacidosis and has not been studied in combination with insulin. The dosage should be individualized based on the patient’s current regimen and the maximum recommended dose is 2.5 mg linagliptin/1000 mg metformin twice a day. It should be given twice daily with meals, with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.

It comes in 3 dosage forms, 2.5 mg linagliptin/500 mg metformin hydrochloride, 2.5 mg linagliptin/850 mg metformin hydrochloride and 2.5 mg linagliptin/1000 mg metformin hydrochloride.

Contraindications include: renal impairment, metabolic acidosis and hypersensitivity to linagliptin or metformin.

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company news release