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

Launched by TAKEDA · Feb 19, 2014

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• 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