Reversal of diabetes and prevention of arteriosclerosis in type 2 diabetic patients with oral antidiabetic agents
Not Applicable
- Conditions
- Type2 Diabetes Mellitus
- Registration Number
- JPRN-UMIN000000947
- Lead Sponsor
- PREVENT-J Study Steering Committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
-Heart failure or history of heart failure. -EF of less than 40%. -History of adverse reactions to a thiazolidine derivative or concerns about safety. -Severe hepatic dysfunction. -Severe renal dysfunction. -History of cardiovascular disease. -Current treatment with a sulfonylurea drug. -Current treatment with a thiazolidine derivative. -Current treatment with insulin. -Those whom the principle investigator or other investigators consider unsuitable.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Duration of the period during which the patients's HbA1c level continued to be less thna 7.0% after completion of dosing (i.e. the observation period of 1.5 yrs) (Kaplan-Meier method). -Duration of dosing (i.e. during the 1.5 years after registration) in which the patient's HbA1c level continued to be less than 7.5% (Kaplan-Meier method). -Indices for atherosclerosis: hsCRP, urinary 8-OHdG, and adiponectin.
- Secondary Outcome Measures
Name Time Method -Proportion of patients who achieved an HbA1c level of less than 6.5% after 1.5 years of dosing (Kaplan-Meier method). -Duration of the period in which the patient's HbA1c levels continued to be less than 5.8% (Kaplan-Meier method). -Cardiovascular events (Kaplan-Meier method) -Urinary microalbumin (adjusted for creatinine) -Insulin and proinsulin -Changes in lipids: TC, TG, HDL-C, LDL-C -Changes in blood pressure -Changes in liver tests: ALT, AST, g-GTP, and LDH). Safety: edema, hypoglycemia, and others.