FDA Triple Play Against Type 2 Diabetes
January was a banner month for type 2 diabetes (T2DM) drugs, with the FDA approving the new dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin as monotherapy (Nesima) and, simultaneously, in combination with metformin(Drug information on metformin) (Kazano) and pioglitzone (Oseni). DPP-4 inhibitors block the degradation of active incretin hormones (GLP-1 and GIP), stimulating the release of insulin in a glucose-dependent manner and decreasing levels of circulating glucagon(Drug information on glucagon).
• Alogliptin was approved based on the results of 14 clinical trials that included about 8,500 people with T2DM. The drug improved HbA1C by a range of 0.4% to 0.6% compared with placebo.
• The alogliptin and metformin combination was approved based on data from 4 trials that included more than 2,500 patients with T2DM. It improved HbA1C by 1.1% compared with alogliptin alone and by 0.5% compared with metformin alone.
• Alogliptin and pioglitazone(Drug information on pioglitazone) in fixed-dose combination was approved based on data from 4 clinical trials including more than 1,500 patients with T2DM. Combining alogliptin with pioglitazone reduced HbA1c by 0.4% to 0.6% compared with pioglitazone alone and by 0.4% to 0.9% compared with alogliptin alone.
Alogliptin is the fourth DPP-4 inhibitor to win FDA approval, joining sitagliptin(Drug information on sitagliptin) (Januvia), saxagliptin (Onglyza), and linagliptin (Tradjenta). As condition of the approval, manufacturer Takeda will be required to conduct 5 postmarketing studies of alogliptin, including one focusing on cardiovascular events as well as "an enhanced pharmacovigilance program" targeting liver abnormalities, pancreatitis, and hypersensitivity reactions.
Read the FDA news release on approval of these 3 antidiabetes agents, here.