Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company, Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines.
On 28 September 2016 at Osaka, Japan,– Takeda Pharmaceutical Company Limited 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® with the generic name: alogliptin benzoate) and metformin hydrochloride (hereinafter “metformin”) for the treatment of type 2 diabetes in japan.
WHAT IS INISYNC?
- Inisync tablets are the combination of 25 mg Nesina and 500 mg metformin, which should be taken once daily orally.
- Nesina is a once-daily dipeptidyl peptidase-IV (DPP-4) inhibitor,
- 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.
HOW IT GOT ITS APPROVAL?
- It conducted clinical studies on the new drug formulation and conducted phase III study for Inisync in Japan.
- In all the studies, Nesina and metformin were concomitantly administered and investigated for safety and efficacy. And also investigated for combination of ingredients and it was proved to have efficacy and safety.
- The results of the Phase III study have shown significantly higher effects in improving HbA1c in regards to the changes in HbA1c.
- Comparing to individual drug and combination of Nesina and Metformin once daily, confirmed that the safety and the tolerance were equal in the concomitant intake compared to the individual administration of Nesina only or metformin only.
TYPE 2 DIABETES AND JAPAN
“In Japan 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.” Emiko Koumura, M.D., Ph.D., Senior Director of Clinical Science, Takeda Development Center Japan says “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.”
HOW DOES IT WORK?
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 |
| Indication | 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. |
Takeda’s previous contributions for Diabetes
Takeda’s heritage in diabetes globally includes significant contributions towards scientific discovery and exchange.
It started with the discovery of the thiazolidinedione (TZD) pioglitazone,
The 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.
Keywords: Diabetes, metformin, Japan, Takeda, inisync.
