type 2 diabetes mellitus
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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. - 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the changes in global longitudinal strain of the left ventricle (GLSLV) achieved with dapagliflozin versus placebo after 6 weeks of double-blind treatment.; Secondary Objective: To compare the changes in myocardial efficiency (%) achieved with dapagliflozin versus placebo after 6 weeks of double-blind treatment. Exploratory objectives: - To compare the changes in myocardial perfusion (ml/min/g) measured by [11C]-Acetate achieved with dapagliflozin vs. placebo after 6 weeks of double-blind treatment. - To compare the changes in myocardial fatty acid uptake (MFAU, µmol/min/g) by [18F]-FTHA) achieved with dapagliflozin versus placebo after 6 weeks of double-blind treatment. - To compare the changes in Left atrial volume (min, max) (mL), Left atrial ejection fraction (%) and transmitral flow velocity indicies (E/A (1), E (cm/s), A (cm/s) and DT (ms)), achieved with dapagliflozin versus placebo after 6 weeks of double-blind treatment. ;Primary end point(s): Change from baseline in GLSLV (%).;Timepoint(s) of evaluation of this end point: End of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in myocardial efficiency (%). Exploratory end points: - Changes from baseline in myocardial perfusion measured by [11C]-Acetate - Changes from baseline in myocardial fatty acid uptake by [18F]-FTHA - Changes from baseline in Left atrial min volume, Left atrial max volume, Left atrial ejection fraction and transmitral flow velocity indicies (E/A, E, A and DT) ;Timepoint(s) of evaluation of this end point: End of treatment | — |
Countries
Finland, Sweden
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed