Effect of the antidiabetic drug dapagliflozin on the coronary function in type 2 diabetic patients.

Phase 1

• Conditions: Coronary macrovascular and microvascular function of type 2 diabetic patients with stable coronary artery disease and acute coronary syndrome (excluding ST elevation myocardial infarction).; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-003310-39-BE
• Lead Sponsor: CHU Saint Pierre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-30
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.T2DM patients presenting with stable angina and a clinical indication for cardiac catheterization
2.T2DM patients with NSTEMI or unstable angina referred for cardiac catheterization
3.Demonstration of coronary lesion(s) with non-significant fractional flow reserve (FFR) values (>0.80), for which revascularisation is deferred
4.Agreement to practice an acceptable method of birth control for women of childbearing potential
5.Signed patient informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Age < 18 years old
2.Pregnancy or breastfeeding
3.Body mass index =45 kg/m2.
4.Creatinine clearance =45 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR).
5.Indication of liver disease, defined by serum levels of alanine amininotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal during screening or run-in phase
6.Uncontrolled hyperglycemia with glucose >240 mg/dL after an overnight fast
7.Stroke, or transient ischemic attack within 2 months prior to informed consent
8.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
9.Any uncontrolled endocrine disorder except type 2 diabetes
10.Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
11.Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at time of screening leading to unstable body weight
12.Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 2 years
13.Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
14.Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
15.Planned cardiac surgery or angioplasty within 3 months
16.Any clinical condition that would jeopardize patient safety while participating in this clinical trial (in Canada, this included current genito-urinal infection or genito-urinal infection within 2 weeks prior to informed consent)
17.Life expectancy < 3 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified