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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,067
Pioglitazone Tablets
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Time frame: Up to Week 52
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in Fasting Triglycerides
Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in HDL Cholesterol
Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in LDL Cholesterol
Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points
Number of participants who received study drug and specific daily dose of insulin product during the survey was reported. Daily dose of insulin was categorized by \< 30 units, \>= 30 and \< 60 units, \>= 60 and \< 90 units, \>= 90 units at each time points.
Time frame: Baseline, Week 52, and final assessment (up to Week 52)
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