Status:
TERMINATED
Glitazones and Endothelial Function (GATE)
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine if the addition of rosiglitazone to subjects with fair glucose control on other oral agents improves endothelial function, a surrogate marker of vascular healt...
Detailed Description
The vascular endothelium has emerged as a critical determinant of cardiovascular health and disease, and improving endothelial function is an important target for therapy. Accumulating evidence sugges...
Eligibility Criteria
Inclusion
- All patients (both men and women) considered for participation in GATE study have to be non-insulin dependent diabetics (according to Canadian Diabetes Association criteria, namely a fasting serum glucose ≥ 7.0 mmol/L on two occasions, a casual glucose ≥ 11.1 mmol/l with symptoms, or a 2-h post-oral glucose tolerance test glucose of ≥ 11.1 mmol/l) with unsatisfactory glycemic control on oral therapy (HbA1c 6-10%).
Exclusion
- Exclusion criteria includes, congestive heart failure (NYHA class III \& IV or ejection fraction less than 35%), poorly controlled hypertension (blood pressure \> 160/90), hypercholesterolemia (total cholesterol \> 6.2 mmol/l), hypertriglyceridemia (triglycerides \> 4.0 mmol/l), poor or excellent control of DM (HgA1c \<6 % or HbA1c \> 10% respectively), known diabetic retinopathy, age at diagnosis of diabetes less than 25 years, current participation in another clinical trial and contraindications to glitazones therapy, including renal (creatinine \> 200 micromol/ L) or hepatic (ALT \> 2.5 times the upper limit of normal) impairment and/ or known intolerance to glitazones. Patients must be stable on medications that affect endothelial function for more than one month. This includes ACE-inhibitors, angiotensin receptor blockers, statins, calcium channel blockers, hormone replacement therapy and anti-oxidant vitamins, including folates. Patients on insulin will be excluded. Patients in whom it is felt that attainment of better glucose control is required within 3 months will also be excluded. Patients with stable coronary disease will be eligible for the study as long as they are \> one month post myocardial infarction, percutaneous intervention or bypass surgery.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00203632
Start Date
September 1 2003
End Date
October 1 2007
Last Update
November 3 2008
Active Locations (1)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9