Comparison of the effects on BS control, plasma lipid and atherogenesis among pioglitazone and metformin in Japanese type 2 diabetic patients

UMIN ID: UMIN000000733

Registered date:01/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus
• Date of first enrollment: 2003/07/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Administration of pioglitazone In the first 3 months followed by the administration of metformin for three months.
Administration of metformin In the first 3 months followed by the administration of pioglitazone for three months.

Outcome(s)

• Primary Outcome: HbA1c, PWV, urinary 8-OHdG, PAF acetylhydrolase
• Secondary Outcome: FBS, insulin, total cholesterol, HDL-C, triglycerides, LDL-C, hsCRP, urinary F2-isoprostanes

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) type 1 diabettes patient 2) patient on insulin treatment 3) Diabetic ketoasidosis, diabetic coma or pre-coma 4) Who takes probucol 5) Who takes supplements containing vitamin C or Vitamin E 6) Severe liver dysfunction 7) Who has a history of adverse effect with pioglitazone 8) renal failure (plasma creatinine more than 1.2 mg/dl, daily urine protein more than 1.0g) 9) heart failure 10) history of heart failure and miocardial infarction within 6 months. Who has a abnormal ECG finding. 11) history of cerebrovascular disease. 12) Who needs insulin administration for clinical condition. 13) Who has a history of hypersensitivity against pioglitazone or metformin. 14) Cases which meet the criteria for prohibition of metformin administration 15) patient who is pregnant of brest-feeding. patient who has a possibility of pregnancy. 16) Who suffers from malignant disease. 17) addiction to alcohol or drug 18) Who are enrolled in the other clinical trials. 19) Who is judged by the investigators to be inappropiriate for this study.

Related Information

• Primary Sponsor: Department of Metabolic Diseases, Graduate School of Medicine, University of Tokyo
• Source(s) of Monetary Support: self funding