Reversal of diabetes and prevention of arteriosclerosis in type 2 diabetic patients with oral antidiabetic agents

UMIN ID: UMIN000000947

Registered date:14/12/2007

Basic Information

• Health condition(s) or Problem(s) studied: Type2 Diabetes Mellitus
• Date of first enrollment: 2007/12/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Diet and exercise intervention
Pioglitazone (15-30 mg/day)
Sulfonylureas

Outcome(s)

• Primary Outcome: -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: -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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: PREVENT-J Study Steering Committee
• Source(s) of Monetary Support: Japan Cardiovascular Research Foundation