Diabetes Mellitus Type 2 Clinical Trial
— DAPACARDOfficial title:
A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients
Verified date | April 2020 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.
Status | Completed |
Enrollment | 53 |
Est. completion date | March 19, 2019 |
Est. primary completion date | March 19, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. - Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses. - Females or males =40 years up to 75 years of age. - 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. - 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. 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: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function 2. Unstable heart failure or any heart failure with NYHA class III and IV 3. Significant valvular disease 4. 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. |
Country | Name | City | State |
---|---|---|---|
Finland | Research Site | Turku | |
Sweden | Research Site | Uppsala |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Finland, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adjusted Mean Change From Baseline in Global Longitudinal Strain of the Left Ventricle (GLSLV) at End of Treatment. | Patients underwent magnetic resonance imaging (MRI) examination to determine the GLSLV, which is expressed as a percentage. The least square mean (LSM) change from baseline estimates were generated from an analysis of covariance (ANCOVA) model with treatment and baseline value of the endpoint as covariates. | Baseline (Day 1) and end of treatment (Day 42) | |
Secondary | Adjusted Mean Change From Baseline in Myocardial Efficiency at End of Treatment. | A clinical radiologic assessment of acquired computed tomography and positron emission tomography (CTPET)-[11C]-acetate images was performed to determine myocardial efficiency. The myocardial efficiency calculation was based on an estimate of energy used for producing LV contractile work (mean arterial pressure (MAP) x stroke volume (SV) x heart rate (HR) / myocardial mass) compared to the total cardiac work (calculated based on the total myocardial oxygen consumption per myocardial mass) and is expressed as a percentage. The LSM change from baseline estimates, were generated from an ANCOVA model with treatment and baseline value of the endpoint as covariates. | Baseline (Day 1) and end of treatment (Day 42) |
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