Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"

Takeda

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Pioglitazone

Study type: Observational

Funder types: Industry

Identifiers

NCT02068508

237-018

JapicCTI-R171012 (Other Identifier)

JapicCTI-132376 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in the routine clinical setting in combination with an insulin product in patients with type 2 diabetes mellitus who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy.

Full description

This is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (Actos Tablets) as part of routine medical care in patients with type 2 diabetes mellitus who have poorly controlled blood glucose when using an insulin product in addition to diet therapy and exercise therapy; this survey is designed to determine the safety and efficacy of long-term use of pioglitazone tablets (Actos Tablets) in the routine clinical setting in combination with an insulin product (the planned sample size, 1000.) The usual adult dosage is 15 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 30 mg.

Enrollment: 1,067 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants with type 2 diabetes mellitus assumed to have insulin resistance who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy who meet the following criteria at enrollment.

1. Participants treated with an insulin product for at least 4 weeks
2. Participants who started Actos Tablets for the first time after the start of an insulin product
3. Participants likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets

Exclusion criteria

Participants with contraindications to Actos Tables and insulin products treatment

Trial design

1,067 participants in 1 patient group

Pioglitazone

Description:

Pioglitazone 15 mg to 30 mg, orally, once daily

Treatment:

Drug: Pioglitazone