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

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

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.

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.

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