Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Paul Heart Clinic
• Collaborator: GlaxoSmithKline
• Treatments: Glyburide; Rosiglitazone

Criteria

Inclusion Criteria:

• Age 25-75 years

• Type 2 diabetes mellitus for less than or equal to 10 years

• Pre-screening HbA1c > 6.5 %

• Screening 110 mg/dl < fasting plasma glucose < 240 mg/dl after 2 weeks of metformin 500 mg twice daily (b.i.d.)

Exclusion Criteria:

• Thiazolidinedione or sulfonylurea use in previous 30 days (may undergo washout period of 30 days)

• Known contraindications to use of thiazolidinedione or sulfonylurea

• Female patients must be postmenopausal, surgically sterile, or using adequate contraception

• Uncontrolled hyperlipidemia according to American Heart Association (AHA) guidelines

• Subcutaneous insulin use

• Elevated liver enzymes (2.5 times the upper limit of the reference range)

• Serum creatinine >160 mmol/l

• Anemia (Hb <11 g/dl for men or <10 g/dl for women)

• Body mass index (BMI) <22 or >42 kg/m2

• History of ketoacidosis

• Angina/New York Health Academy class III/IV cardiac insufficiency

• Electrocardiographic evidence of marked left ventricular hypertrophy

• Uncontrolled hypertension according to AHA guidelines

• Hemoglobinopathy