type 2 diabetes mellitus
Conditions
Interventions
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
Sponsors
Department of Metabolic Diseases, Graduate School of Medicine, University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who had been treated with diet therapy, exercise therapy, and/or sulfonylurea for more than 3 months. 2) The level of HbA1c: If not administered with pioglitazone or metformin, 6.5% to 8.4%. If administered with pioglitazone or metformin, 6.0% to 7.9%, and after cessation of pioglitazone or metformin, 6.5% to 8.4% 3) The change in HbA1c level is less than 10% in the last 3 months. 4) SBP less than 140 mmHg. 5) Cigarettes smoking less than 20 per day. 6) no criteria in BMI level. 7) patients followed in outpatient department. 8) Who can understand the protocol and have the ability to agree with this study.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c, PWV, urinary 8-OHdG, PAF acetylhydrolase | — |
Secondary
| Measure | Time frame |
|---|---|
| FBS, insulin, total cholesterol, HDL-C, triglycerides, LDL-C, hsCRP, urinary F2-isoprostanes | — |
Countries
Japan
Outcome results
None listed