NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus
Date of first enrollment	16/12/2013
Target sample size	1000
Countries of recruitment
Study type	Observational
Intervention(s)	investigational material(s) Generic name etc : Actos Tablets (pioglitazone) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : 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.

Outcome(s)

Primary Outcome

Frequency of adverse drug reactions. Primary timeframe 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

Changes in glycemia-related parameters (fasting blood glucose, glycosylated hemoglobin [HbA1c]), changes in test values (fasting triglycerides, HDL cholesterol, and LDL cholesterol), and changes in the daily dose of insulin product. Secondary timeframe 52 weeks from the baseline Tabulation and analysis of changes in fasting blood glucose, HbA1c, fasting triglycerides, HDL cholesterol, LDL cholesterol, and daily dose of insulin product

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	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. (1) Patients treated with an insulin product for at least 4 weeks (2) Patients who started Actos Tablets for the first time after the start of an insulin product (3) Patients likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets
Exclude criteria	Patients with contraindications to Actos Tables and insulin products treatment