DIAbetes and diffuse coronary Narrowing Analysis Study

UMIN ID: C000000107

Registered date:01/09/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Patients with impaired fasting glucose or type-2 diabetes mellitus, who had coronary artery diseases
• Date of first enrollment: 2005/02/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients treated with voglibose (n=100)
Patients treated with nateglinide (n=100)
patients treated without medication, with diet and exercise (n=100)

Outcome(s)

• Primary Outcome: Lesion length, vessel diameter, percentage diameter stenosis
• Secondary Outcome: MACE (all-cause death, non-fatal myocardial infarction, repeat revascularization, the occurrence of anginal chest pain), diabetic complication, the change of % diameter stenosis after PCI, the change of minimum lesional diameter after PCI, the occurrence of restenosis, the development of new stenotic lesion, the change of glycemic status

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) patinets with acute myocardial infarction within 48 hrs 2) patients who previously underwent coronary artery bypass surgery 3) patients who were being treated by anti-diabetic medication 4) patients who had allergic reaction to voglibose or nateglinide 5) patients with real insufficiency (serun creatinine more than 2.0mg/dl) 6) patients who were seriously ill

Related Information

• Primary Sponsor: National Cardiovascular Center
• Source(s) of Monetary Support: Japan Cardiovascular Research Foundation