The European Commission has given Marketing Authorization to Jentadueto (linagliptin/metformin hydrochloride) tablets,Boehringer Ingelheim and Eli Lilly’s 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 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.
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 percent.
Jentadueto was approved by the U.S. 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
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.