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

Takeda

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Pioglitazone

Study type: Observational

Funder types: Industry

Identifiers

NCT02003014

JapicCTI-132329 (Registry Identifier)

237-017

JapicCTI-R160828 (Registry Identifier)

Details and patient eligibility

About

To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos tablets) in combination with biguanides (for 12 months after the start of pioglitazone tablets treatment) in patients with type 2 diabetes mellitus.

Full description

This is a special drug use surveillance with an observation period of 12 months designed to investigate the safety and efficacy of pioglitazone (Actos) in the routine clinical setting in patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy (planned sample size, 1000).

The usual adult dosage is 15 to 30 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 45 mg.

Enrollment: 899 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy
2. Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment
3. Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment

Exclusion criteria

1. Patients who have received Actos Tablets within the past 3 months.
2. Patients who started treatment with biguanides and Actos Tablets simultaneously
3. Patients who discontinued biguanides and switched to Actos Tablets treatment.
4. Patients who received additional biguanides after the start of Actos Tablets treatment
5. Patients with contraindications to Actos Tablets treatment

Trial design

899 participants in 1 patient group

Pioglitazone 15 mg to 30 mg

Description:

administered orally once daily

Treatment:

Drug: Pioglitazone