| Trial ID: | L6938 |
| Source ID: | NCT03387683
|
| Associated Drug: |
Dapagliflozin
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| Title: |
A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients
|
| Acronym: |
DAPACARD
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03387683/results
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: dapagliflozin|DRUG: placebo
|
| Outcome Measures: |
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)
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
53
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-02-28
|
| Completion Date: |
2019-03-19
|
| Results First Posted: |
2020-03-25
|
| Last Update Posted: |
2020-04-27
|
| Locations: |
Research Site, Turku, 20520, Finland|Research Site, Uppsala, SE-751 85, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT03387683
|
