Jentadueto Approved for Type 2 Diabetes

The US Food and Drug Administration (FDA) announced on Monday that it had approved Jentadueto (linagliptin/metformin hydrochloride), an oral combination therapy to treat patients with type 2 diabetes. The drug is co-marketed by Boehringer Ingelheim Pharmaceuticals, Inc and Eli Lilly and Co. The companies also market Tradjenta (linagliptin) tablets to treat type 2 diabetes, which the FDA approved in May 2011. The new medication combines linagliptin (a dipeptidyl peptidase-4 inhibitor) with metformin (a common first-line therapy for type 2 diabetes) into 1 pill taken twice per day. The drug, combined with diet and exercise, is intended to control blood sugar. In a 24-week, randomized, double-blind study, patients who took 2.5 mg linagliptin/1,000 mg metformin hydrochloride had reductions in hemoglobin A1c levels up to 1.7% compared with a placebo group. The results were superior to 5 mg of linagliptin once daily (reduction of 0.6% compared with placebo), 500 mg metformin twice daily (0.8% reduction), 2.5 mg linagliptin/500 mg metformin twice daily (1.3% reduction), and 1,000 mg metformin twice daily (1.2% reduction). The Eli Lilly news release can be found at https://investor.lilly.com/releasedetail2.cfm?ReleaseID=643919 The Boehringer Ingelheim news release can be found at https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/31_january_2012_diabetes.html A Dow Jones Newswire story is available at https://online.wsj.com/article/BT-CO-20120130-716878.html -Tim Casey