Takeda Pharmaceutical Company Limited has announced that Inisync Combination Tablets, a fixed-dose combination of Nesina (generic name: alogliptin benzoate) and metformin hydrochloride (hereinafter metformin), is now available in Japan for the treatment of type 2 diabetes.

Inisync combination tablets combine 25 mg alogliptin and 500 mg metformin, which is orally administered once daily. Nesina is a once-daily dipeptidyl peptidase-IV (DPP-4) inhibitor, and metformin is biguanide that inhibits sugar production in the liver administered twice or three times daily. Both of them are widely used as therapeutic drugs for the treatment of diabetes. Inisync is the only combination administered once daily of a DPP-4 inhibitor and metformin in Japan.

The approval for Inisync was granted based on the efficacy and safety data in the existing clinical studies related to Nesina and the phase III study for Inisync in Japan in which the compounds of this combination, Nesina and metformin, were concomitantly administered.

“Pathology and treatment of type 2 diabetes are complex and the needs of patients and the treatment options have diversified,” said Masato Iwasaki, Ph.D., director and president, Japan Pharma Business Unit of Takeda. “We have launched the once-weekly DPP-4 inhibitor, Zafatek, last year. We continue our efforts such that our newly launched product, Inisync combination tablets can be utilized as a new treatment option and we continue to contribute to healthcare professionals and patients in Japan through therapeutic drug advances for the treatment of diabetes.”

A DPP-4 inhibitor enhances the insulin secretion based on the plasma glucose levels, and it controls the levels by selectively inhibiting DPP-4 activity that inactivates two hormones, the incretin hormones (gastrointestinal hormones that promote insulin secretion) that play important roles in adjusting blood glucose, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).