Magazine article Drug Topics

FDA Approves Three New Therapies for Type 2 Diabetes

Magazine article Drug Topics

FDA Approves Three New Therapies for Type 2 Diabetes

Article excerpt


On January 26, 2013, FDA approved three new type 2 diabetes therapies: alogliptin monotherapy (Nesina, Takeda) and two fixed-dose combinations, alogliptin and pioglitazone (Oseni, Takeda) and alogliptin and metformin HCl (Kazano, Takeda).

Alogliptin is a dipeptidyl peptidase-4 S(DPP-4) inhibitor designed to slow the inactivation of incretin hormones GLP-I (glucagon-like peptide- 1) and GIP (glucose-dependent insulinotropic peptide). Alogliptin is approved for use either as monotherapy as an adjunct to diet and exercise or in a combination regimen to improve glycémie control in patients with type 2 diabetes. Alogliptin is not indicated for treatment of type 1 diabetes or diabetic ketoacidosis.

In mid-March, FDA announced that it was evaluating reports of possible increased risk of pancreatitis and precancerous findings of the pancreas associated with incretin mimetics, which includes alogliptin monotherapy and the fixed-dose combinations. FDA has not reached any conclusions about the safety risks linked to incretin mimetics. In June, FDA will participate in the National Institute of Diabetes and Digestive and Kidney Diseases and National Cancer Institute's Workshop on Pancreatitis-Diabetes-Pancreatic Cancer to obtain and share additional information.


Alogliptin has been studied in more than 1 3,000 patients internationally, as monotherapy in addition to diet and exercise and in combination with metformin, insulin, thiazoladinediones, and sulfonylureas. In a placebo-controlled trial of 329 patients conducted over 26 weeks, alogliptin reduced AIc significantly compared to placebo (-0.6%, 95% a -0.8 to -0.3), when added to diet and exercise. In another randomized trial, alogliptin monotherapy was compared to 30 mg pioglitazone dosed daily and to alogliptin combined with pioglitazone. In reducing AIc at 26 weeks, the combination was superior to either alogliptin or pioglitazone alone (-0.8%, 95% a -1.0 to -0.5 and -0.6%, 95% a -0.8 to -0.3, respectively). Similarly, in a third trial, alogliptin combined with metformin was superior in reducing AIc compared to either drug alone at 26 weeks (difference from metformin monotherapy ranged from -0.4 to -0.6 and from alogliptin monotherapy ranged from -0.7 to -1.0).

Several trials have been conducted in patients who were failing current antihyperglycemic therapy. When added to a regimen of insulin with or without metformin, alogliptin significantly reduced AIc by 0. …

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