Status:
COMPLETED
Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
Lead Sponsor:
St. Paul Heart Clinic
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
Brief 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.
Detailed Description
Rosiglitazone and glyburide are two commonly used diabetic medications that have both been shown to be effective in controlling blood glucose levels. Since they work in different ways, they may have d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00123643
Start Date
May 1 2003
End Date
December 1 2005
Last Update
July 15 2013
Active Locations (1)
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1
St. Paul Heart Clinic
Saint Paul, Minnesota, United States, 55102