Takeda Announces the Approval of Changes to the NESINA® Indication in Japan

-Broader Indication Allows For Use with All Oral Anti-Diabetic Agents and Insulin-

Osaka, Japan, May 23, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare has approved an application for changes to the Nesina® indication, a treatment for type 2 Diabetes. The newly approved indication is "Type 2 Diabetes" which now allows concomitant therapy of Nesina with all the oral anti-diabetic agents and insulin.

Nesina is a once-daily dipeptidyl peptidase-IV (DPP-4) inhibitor. It controls blood glucose levels by selectively and continually inhibiting DPP-4, an enzyme that causes the inactivation of glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide, incretin hormones* that play an important role in blood glucose regulation. The inhibition of DPP-4 increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels.

The application approval was based on the results of long-term concomitant therapy trials of Nesina with other anti-diabetic agents in Japan. Aiming to change the indication of Nesina to “Type 2 Diabetes”, a clinical trial evaluating the efficacy and safety of concomitant therapy of Nesina with a rapid-acting insulin-secretion stimulating agent, which was not a part of approved indications, was conducted in accordance with the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents, and the data of this trial demonstrated patients benefit. In an additional effort to establish the clinical efficacy and safety of the concomitant therapy of Nesina with insulin, a clinical trial evaluating the efficacy and safety of Nesina in combination with insulin was also conducted, and the result of this trial also demonstrated patients benefit.

The new indication makes Nesina more useful to healthcare professionals, as they will have a treatment that allows them to provide the optimized treatment to each patient according to their individual needs.

*An insulinotropic gastrointestinal hormone

Indication of Nesina
Before Indication Change
After Indication Change
Type 2 diabetes
In patients inadequately glycemic controlled by following treatments,
  • 1. Treatment of diet therapy and exercise only
  • 2. In addition to treatment by diet and exercise, treatment by alpha-glucosidase inhibitor
  • 3. In addition to treatment by diet and exercise, treatment by thiazolidinediones
  • 4. In addition to treatment by diet and exercise, treatment by sulfonylurea
  • 5. In addition to treatment by diet and exercise, treatment by biguanide
Type 2 diabetes

 

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