Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

Completed · Phase 4

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00123643

Run by

St. Paul Heart Clinic

People needed

36

Starts

2003-05-01

Expected to finish

2005-12-01

Last updated by the study team

2013-07-15

Who can join

Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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

Where it is running

• St. Paul Heart Clinic — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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