Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in Type 2 Diabetes

UMIN ID: UMIN000001891

Registered date:15/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 2009/02/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

pioglitazone
metformin

Outcome(s)

• Primary Outcome: Glucose variability in CGM (area under the glucose curve from pre-meal baseline to baseline, pattern of glucose curve, magnitude of increase in glucose levels and the time to peak glucose levels from baseline after each meal)
• Secondary Outcome: Pre-meal plasma glucose, 2 hour post prandial glucose, side effect, body weight change

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Patients with type 1 diabetes, patients with severe liver disease, patients with severe renal disease, patients with severe heart disease, patients with history of myocardial infarction within 6 months, patients with severe pancreatic disease, cancer patients, patients with severe diabetic neuropathy, patients with severe diabetic retinopathy, patients with history of lactic acidosis, heavy drinkers, pregnant patients

Related Information

• Primary Sponsor: Jikei University School of Medicine
• Source(s) of Monetary Support: Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine