Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
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The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in in the routine clinical setting in combination with 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.
Condition or disease
Type 2 Diabetes Mellitus
This is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (Actos Tablets) 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 in the routine clinical setting in combination with 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.
Frequency of adverse drug reactions [ Time Frame: 52 weeks from the baseline ]
Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions..
Secondary Outcome Measures
Changes in glycemia-related parameters (fasting blood glucose, glycosylated hemoglobin [HbA1c]) [ Time Frame: 52 weeks from the baseline ]
Tabulation and analysis of fasting blood glucose and HbA1c.
Changes in test values (fasting triglycerides, HDL cholesterol, and LDL cholesterol) [ Time Frame: 52 weeks from the baseline ]
Tabulation and analysis of fasting triglycerides, HDL cholesterol, and LDL cholesterol)
Changes in the daily dose of insulin product [ Time Frame: 52 weeks from the baseline ]
Tabulation and analysis of the daily dose of insulin product.
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Type 2 diabetes mellitus
Patients 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.
Patients treated with an insulin product for at least 4 weeks
Patients who started Actos Tablets for the first time after the start of an insulin product
Patients likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets
Patients with contraindications to Actos Tables and insulin products treatment