FDA approval for Jentadueto (metformin plus linagliptin)

By Professor Juan Tamargo, Madrid, Spain.

The FDA has approved Jentadueto, a combination of metformin plus linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor for type 2 diabetes. JENTADUETO provides a new, single-tablet treatment option, taken twice-daily, for patients who need to improve glycemic control, in combination with diet and exercise. Other metformin/DPP-4 inhibitor combinations include sitagliptin (Janumet) and saxagliptin (Kombiglyze).

The approval of Jentadueto was based on a 24-week r randomized, double-blind, placebo-controlled factorial study of 791 adults with type 2 diabetes and inadequate glycemic control with diet and exercise. At the maximum dose tested (5 mg linagliptin/1,000 mg metformin twice-daily), JENTADUETO demonstrated placebo-corrected reductions in hemoglobin A(1c) levels of up to -1.6% as compared with a 0.1% increase for the placebo. The most common adverse effects (and more commonly than in patients treated with placebo) included stuffy or runny nose, sore throat and diarrhea. The trial show that hypoglycemia was more common in patients treated with the combination of JENTADUETO and sulfonylurea compared with those treated with the combination of placebo, sulfonylurea and metformin (22.9% versus 14.8%, respectively). Pancreatitis was reported more often in patients randomized to linagliptin (one per 538 person-years versus zero in 433 person-years).