Osaka, Japan  – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that an additional indication of concomitant therapy with insulin for ACTOS^® (pioglitazone hydrochloride), a medicine for the treatment of type 2 diabetes, was approved on March 24 by the Ministry of Health, Labour and Welfare.

ACTOS directly targets insulin resistance, a condition characterized in patients with type 2 diabetes, by improving the sensitivity to insulin mainly in the muscles, fat cells and the liver. The approved concomitant therapy now makes it possible to administer ACTOS to patients inadequately controlled by diet, exercise and insulin administration. The approved dosage is, as an adjunct to diet and exercise, to administer ACTOS 15 mg orally once daily in adults before or after breakfast. Depending on gender, age or symptoms, the dose can be increased up to 30 mg, if appropriate.

In a randomized, double-blind, comparative study in which ACTOS was administered to patients with type 2 diabetes treated with a regimen of diet, exercise and insulin administration, the ACTOS/insulin concomitant therapy group showed a statistically significant difference in improving HbA1c –an indicator of glycemic control– than that of the insulin monotherapy group. It is expected that this additional indication for concomitant therapy of ACTOS, an insulin sensitizer, with insulin will provide a new option in drug therapy and contribute to improved glycemic control for patients with type 2 diabetes.

In addition to monotherapy, the indications for ACTOS in Japan were previously approved for concomitant therapies with a sulfonylurea, an alpha-GI or a biguanide. With this approval of concomitant therapy with insulin, ACTOS becomes the diabetes drug with the most number of approved concomitant therapies with various diabetes drugs in Japan. Takeda will continue to earnestly maximize the value of ACTOS and promote development activities that offer a variety of treatment options to patients with type 2 diabetes and also to healthcare providers.

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Contact: Takeda

Source: Takeda Pharmaceutical Company Limited