A clinical study to investigate the effects of dapagliflozin on heart work, heart nutrient uptake, and heart muscle efficiency in type 2 diabetes patients - DAPACARD

Exclusion Criteria

• - 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.
• - 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
• -Planned cardiac surgery or angioplasty within 3 months from enrolment.
• - Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.
• - Verified body weight variability of >3 kg during the 3 proceeding months before screening.
• - Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).
• - Patients with severe hepatic impairment (Child-Pugh class C).
• - Unstable or rapidly progressing renal disease.
• - Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
• - 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.
• - Contraindications to dapagliflozin therapy.
• - 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.
• - Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.
• - Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.
• - 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.
• - 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).
• - Involvement in the planning and/or conduct of the study.
• - Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.
• - Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.