A study in type 2 diabetes patients to investigate the effects of DAPAgliflozin on the heart (CARDiac) work, heart nutrient uptake and heart muscle work
- Conditions
- type 2 diabetes mellitusTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-003820-58-FI
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 52
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of =42 mmol/mol (6.0%) and =75 mmol/mol (9.0%) measured at local hospital laboratory.
- Females or males =40 years up to 75 years of age.
- No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.
- Normal left ventricular ejection fraction (=50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.
- Body mass index (BMI) = 25 kg/m2.
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- Blood pressure at screening that would require a change in blood pressure treatment over
the study period or any of the following: systolic blood pressure >160 mmHg or diastolic
blood pressure >100 mmHg.
- History of stroke or other clinically significant cerebrovascular disease.
- Planned cardiac surgery or angioplasty within 3 months from enrolment.
- Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment:
a.Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function
b.Unstable heart failure or any heart failure with NYHA class III and IV
c.Significant valvular disease
d.Significant peripheral artery disease
- Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.
- Patients with severe hepatic impairment (Child-Pugh class C).
- Unstable or rapidly progressing renal disease.
- Ongoing treatment with other antidiabetic drugs than metformin.
- Ongoing treatment with loop diuretics.
- Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.
- Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2,
- Women who has a positive pregnancy test at enrolment or randomization, or are
breastfeeding.
- Any condition when MRI and CT-PET is contraindicated such as, but not limited to,
having a metallic implant (such as pacemaker or cochlear implant), permanent make up,
claustrophobia or BMI =40 kg/m2).
- Active malignancy requiring treatment at the time of visit 1 (with the exception of
successfully treated basal cell or treated squamous cell carcinoma).
- Plasma donation within one month of screening or any blood donation/blood loss >450
mL during the 3 months prior to screening.
- Alcohol or drug abuse within the 3 months prior to informed consent that would interfere
with trial participation or any ongoing condition leading to a decreased compliance to
study procedures or study treatment intake.
- Ongoing treatment with systemic steroids at time of informed consent or change in
dosage of thyroid hormones within 6 weeks prior to informed consent or any other
uncontrolled endocrine disorder except for T2D.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method