Phase 4 N=36 Randomized Quadruple-blind Prevention

Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00123643 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcome: Primary: Flow Mediated Dilation — 6.8; 5.5 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: rosiglitazone (Drug); glyburide (Drug)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: St. Paul Heart Clinic
Primary completion: Dec 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Flow Mediated Dilation	6.8; 5.5	—

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.

Eligibility 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 160 mmol/l
Anemia (Hb 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00123643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.