Status:
TERMINATED
Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients
Lead Sponsor:
Centre Hospitalier Universitaire Saint Pierre
Collaborating Sponsors:
AstraZeneca
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Cardiovascular events remain a major driver of morbidity and mortality in patients with type 2 diabetes mellitus. Diffuse coronary atherosclerosis, combined with impairment of the microcirculation are...
Eligibility Criteria
Inclusion
- type 2 diabetes mellitus (T2DM) patients presenting with stable angina and a clinical indication for cardiac catheterization
- T2DM patients with non ST elevation myocardial infarction (NSTEMI) or unstable angina referred for cardiac catheterization
- Demonstration of coronary lesion(s) with non-significant fractional flow reserve (FFR) values (\>0.80), for which revascularisation is deferred
- Agreement to practice an acceptable method of birth control for women of childbearing potential
- Signed patient informed consent
Exclusion
- Age \< 18 years old
- T2DM patients presenting with ST elevation myocardial infarction (STEMI)
- Pregnancy or breastfeeding
- Body mass index ≥45 kg/m2
- Creatinine clearance ≤45 ml/min/1.73 m2 (as calculated by Modification of Diet in Renal Disease Study (MDRD ) formula for estimated Glomerular filtration rate (GFR))
- Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal during screening or run-in phase
- Uncontrolled hyperglycemia with glucose \>240 mg/dL after an overnight fast
- Stroke, or transient ischemic attack at presentation and up to 2 months prior to informed consent
- Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
- Any uncontrolled endocrine disorder except type 2 diabetes
- Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at time of screening leading to unstable body weight
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
- Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- Planned cardiac surgery or angioplasty within 3 months
- Any clinical condition that would jeopardize patient safety while participating in this clinical trial
- Life expectancy \< 3 years
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT05392959
Start Date
June 6 2022
End Date
July 17 2023
Last Update
April 26 2024
Active Locations (1)
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1
CHU Saint Pierre
Brussels, Bruxelles-Capitale, Région de;Brussels Hoofdstedelijk Gewest, Belgium, 1000