Takeda Pharmaceuticals has announced that the FDA ( Food and Drug Administration ) has approved Nesina ( Alogliptin ) and the fixed-dose combination therapies Oseni ( Alogliptin and Pioglitazone ) and Kazano ( Alogliptin and Metformin HCl ) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.

Nesina is a dipeptidyl peptidase-4 inhibitor ( DPP-4i ) that is designed to slow the inactivation of incretin hormones GLP-1 ( glucagon-like peptide-1 ) and GIP ( glucose-dependent insulinotropic peptide ). Oseni, which combines Alogliptin with Pioglitazone, is the first product in the U.S. to include both a DPP-4i and a thiazolidinedione in a single tablet. Kazano combines Alogliptin with Metformin HCl, a widely used anti-diabetes medication, in a single tablet.

The most common adverse events ( greater than or equal to 4% ) reported with Nesina ( Alogliptin ) include nasopharyngitis, headache and upper respiratory tract infection.
With regard to Oseni ( Alogliptin and Pioglitazone ), common adverse events ( greater than or equal to 4% ) reported include nasopharyngitis, back pain and upper respiratory tract infection.
Common adverse events ( greater than or equal to 4%) reported with Kazano include upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection.

Takeda has conducted worldwide placebo- and active-controlled clinical trials of Alogliptin involving more than 13,000 patients. The safety and efficacy of Nesina was studied as a once-daily monotherapy and in combination with several other classes of anti-diabetic medications, including biguanides, thiazolidinediones, Insulin and sulfonylureas. In these studies, Alogliptin 25 mg, taken once daily, demonstrated clinically meaningful and statistically significant improvements in hemoglobin A1C compared to placebo.

Of the total number of patients included in the Nesina clinical trial program, more than 3,000 were included in the studies used to support the FDA approval of Oseni, and more than 4,000 were included in those to support the FDA approval of Kazano. Study results indicated that Alogliptin co-administered with either Pioglitazone or Metformin HCl produced significant improvements in glycemic control as compared to the respective monotherapies.

Source: Takeda, 2013

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