Single and combo diabetes drugs approved

Alogliptin (Nesina) and two new combination drugs (alogliptin and metformin hydrochloride [Kazano] and alogliptin and pioglitazone [Oseni]) were approved by the FDA to improve blood glucose control in adults with type 2 diabetes, along with diet and exercise.

Alogliptin was demonstrated safe and effective in clinical trials of about 8,500 patients in which it reduced hemoglobin A1c (HbA1c) by 0.4% to 0.6% compared with placebo after 26 weeks of use. The combination of alogliptin/metformin reduced HbA1c 1.1% more than alogliptin alone and 0.5% more than metformin alone after 26 weeks. The alogliptin/pioglitazone combination reduced HbA1c 0.4% to 0.9% more than alogliptin monotherapy and 0.4% to 0.6% more than pioglitazone monotherapy. The FDA is requiring five postmarketing studies: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis and severe hypersensitivity reactions; and three pediatric studies. The most common side effects are stuffy or runny nose, headache, and upper respiratory tract infection.