New diabetes drug wins approval
New York, February 1, 2012
The US Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets for adults with Type 2 diabetes.
The new tablet combines the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin and metformin, said a statement from Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company.
Linagliptin/metformin hydrochloride (HCl) provides a new, single-tablet treatment option, taken twice-daily, for adults with Type 2 diabetes who need to improve control of their blood glucose, said the statement.
Linagliptin (5 mg, once-daily) is marketed in the US as Tradjenta (linagliptin) tablets, as Trajenta across Europe and Canada, and Trazenta in Japan, as well as in further markets.
Linagliptin/metformin HCl is a prescription medication used along with diet and exercise to improve glycaemic control in adults with Type 2 diabetes when treatment with both linagliptin and metformin is appropriate. At the maximum dose, linagliptin/metformin HCl demonstrated placebo-corrected reductions in haemoglobin A1c (HbA1c or A1C) levels of up to 1.7 percent (+0.1 percent for placebo and -1.6 percent for linagliptin/metformin HCl), the statement said.
A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. Linagliptin/metformin HCl did not cause any meaningful change in body weight.
Linagliptin/metformin HCl can be used alone or in combination with a sulphonylurea, a commonly prescribed medication for Type 2 diabetes, it said.
Linagliptin/metformin HCl are 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, it said. – TradeArabia News Service