Takeda Obtains New Drug Application Approval for Inisync® Combination Tablets for the Treatment of Type 2 Diabetes in Japan

Takeda Obtains New Drug Application Approval for Inisync® Combination Tablets for the Treatment of Type 2 Diabetes in Japan

September 28, 2016

Osaka, Japan, September 28, 2016 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that Takeda has obtained the New Drug Application Approval from the Ministry of Health, Labour and Welfare for the Inisync® Combination Tablets, a fixed-dose combination of Nesina® (generic name: alogliptin benzoate) and metformin hydrochloride (hereinafter “metformin”) for the treatment of type 2 diabetes.

Inisync combination tablets combine 25 mg Nesina 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 tablets administered once daily of a DPP-4 inhibitor and metformin in Japan.

The approval is based on the results of the existing clinical studies related to Nesina and the Phase III study for Inisync in Japan. In all studies, the efficacy and safety have been investigated for the ingredients of this combination tablets, Nesina and metformin, when they are concomitantly administered. The results of the Phase III study have shown significantly higher effects in improving HbA1c in regards to the changes in HbA1c, the primary endpoint, when Nesina and metformin are concomitantly administered once daily compared to individual administration of Nesina or metformin. It has also been confirmed that the safety and the tolerance were equal in the concomitant intake compared to the individual administration of Nesina only or metformin only.

“The number of patients with type 2 diabetes is increasing every year, but for various reasons, there are many patients who discontinue their diabetes treatment.” said Emiko Koumura, M.D., Ph.D., Senior Director of Clinical Science, Takeda Development Center Japan. “We have various therapeutic options for the treatment of type 2 diabetes, and we have been providing therapeutic options based on the needs of medical professionals as well as of individual patients. I expect that this combination will contribute to improvement in treatment adherence for patients with type 2 diabetes, and to continue their therapies by providing new options for their treatment.”

* 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)

Name of the product

Inisync® Combination Tablets

Generic Name

Alogliptin benzoate and metformin hydrochloride


Type 2 diabetes

However, administration is limited only when it is judged appropriate to treat it concomitantly with alogliptin benzoate and metformin hydrochloride.

Dosage and administration

Usually, for adults, one tablet (25 mg/500mg as alogliptin benzoate/metformin hydrochloride) is orally administered once daily immediately before meals or after meals.


About Takeda’s Diabetes Business
Takeda’s heritage in diabetes globally includes significant contributions towards scientific discovery and exchange, starting with the discovery of the thiazolidinedione (TZD) pioglitazone, the more recent developments of alogliptin and the fixed-dose combinations (FDC) alogliptin and pioglitazone, and alogliptin and metformin HCl. The company’s diverse diabetes portfolio show Takeda’s ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.

About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news