Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the FDA has approved JentaduetoT (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. JENTADUETO provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar. Linagliptin (5 mg, once-daily) is marketed in the U.S. as TradjentaT (linagliptin) tablets.
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. At the maximum dose, JENTADUETO demonstrated placebo-corrected reductions in hemoglobin A(1c) (HbA(1c) or A1C) levels of up to 1.7 percent (+0.1 percent for placebo and -1.6 percent for JENTADUETO). A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months. JENTADUETO did not cause any meaningful change in body weight. JENTADUETO can be used alone or in combination with a sulfonylurea, a commonly prescribed medication for type 2 diabetes. 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. The JENTADUETO label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with JENTADUETO.
"Most people with type 2 diabetes require more than one medication to help lower their blood sugar, due to the complex nature of type 2 diabetes," said Lance Sloan, MD, Texas Institute for Kidney and Endocrine Disorders. "The approval of JENTADUETO is exciting because it combines two diabetes medications in a single tablet, making it a good option for people who need an additional medication, and for whom both linagliptin and metformin is appropriate."