Comparative study of glimepiride and nateglinide on glycemic control in patients with type 2 diabetes mellitus treated with voglibose

UMIN ID: UMIN000000676

Registered date:01/01/2009

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 2007/05/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Administration of glimepiride for 16 wks
Administration of nateglinide for 16 wks

Outcome(s)

• Primary Outcome: Changes in HbA1c levels Changes in postprandial plasma glucose concentrations
• Secondary Outcome: Changes in 1,5-AG levels Changes in glycoalbumin levels Changes in insulin concentrations

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients without type 2 diabetes 2) Patients with alcohol abuse or excessive intake of alcoholic beverages 3) Patients with severe diabetic complications* *nephropathy>=stage 3A *retinopathy>=preproliferative stage in Davis classifications 4) Patients with liver dysfunction (AST and ALT>=80 IU/L) or renal dysfunction (serum creatinie>=1.5mg/dl) 5) Patients with an allergy to any drug 6) Pregnant women and women at child bearing age and not taking adequate contraceptions 7) Patients decided to be irrelevant by the investigators

Related Information

• Primary Sponsor: Nagoya University Graduate School of Medicine
• Source(s) of Monetary Support: Nagoya University Graduate School of Medicine