Boehringer Ingelheim and Eli Lilly and Company announced the receipt of Marketing Authorization from the European Commission for Jentadueto (linagliptin/metformin hydrochloride) tablets, a medicine combining the DPP-4 inhibitor, linagliptin (the active ingredient in Tradjenta tablets, marketed under the trade name Trajenta in Europe) and metformin in a single tablet taken twice daily.
The European Commission has approved Jentadueto for use alongside diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on their maximally tolerated dose of metformin alone, metformin and a sulfonylurea, or those already being treated with the combination of linagliptin and metformin.It may be used with a sulfonylurea, as well. Jentadueto 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.
“We’re delighted that the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance can make Jentadueto available to adult patients with type 2 diabetes across Europe,” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Many patients need more than one treatment to adequately manage their diabetes. Jentadueto offers patients with type 2 diabetes a single-tablet dosing option to improve control of their blood sugar.”
Recently, the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) issued a joint statement that noted it may be justified to begin initial therapy with a combination of two noninsulin agents or with insulin itself for patients with a high baseline hemoglobin A1c (HbA1c or A1C) of greater than or equal to 9.0%.
Jentadueto was approved by the U.S. Food and Drug Administration (FDA) in January 2012 as a prescription medicine 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. The Jentadueto U.S. 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 . In clinical studies, initial combination therapy with Jentadueto was statistically superior to metformin monotherapy and to placebo in improving A1C and fasting plasma glucose (FPG), with a similar safety and tolerability profile. No meaningful change in body weight was noted in any treatment group.
In initial therapy, the maximum dose of 2.5 mg (linagliptin)/1000 mg (metformin HCl) BID, Jentadueto showed placebo-corrected reductions in A1C levels of 1.7% (+0.1% for placebo and -1.6% for Jentadueto ). A1C is measured in people with diabetes to provide an index of blood glucose 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.
Adverse reactions reported in greater than or equal to five% of patients treated with Jentadueto and more commonly than in patients treated with placebo included nasopharyngitis (the common cold) and diarrhea. Hypoglycemia was more commonly reported in patients treated with the combination of Jentadueto and sulfonylurea compared with those treated with the combination of placebo, sulfonylurea and metformin. Pancreatitis was reported more often in patients randomized to linagliptin (1 per 538 person-years versus zero in 433 person-years for comparator).
Linagliptin (5 mg, once daily) is marketed as Trajenta across Europe and Canada, as Tradjenta in the U.S., and Trazenta in Japan, as well as in additional markets.
Date: July 25, 2012
Source: Boehringer Ingelheim and Eli Lilly and Co.
Filed Under: Drug Discovery
