Jikei Nateglinide and Arbs for Vascular Intervention Study

UMIN ID: UMIN000001080

Registered date:15/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus
• Date of first enrollment: 2007/08/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Nateglinide 30 to 90mg per times and Valsartan 80mg
Nateglinide 30 to 90mg per times and Telmisartan 40mg

Outcome(s)

• Primary Outcome: Change in cartoid plaque volume after 24 weeks using 3-Dimensional Ultrasound

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Patients with severe heart disease 2)Patients with severe liver dysfunction 3)Patients with poor glycemic controls(glycated hemoglobin >8.0%) 4)Drug allegy to ARB 5)Patients with hemodialysis 6)Pregnant or possibility of pregnant 7)Patients that treated with pioglitazone within 6 months 8)Patients with renal dysfunction(serum creatinine>3.0mg/dl) 9)Other patients judged inappropriate for the study by the investigators

Related Information

• Primary Sponsor: tokyo jikei university school of medicine
• Source(s) of Monetary Support: The Jikei University School of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine