Diabetes Mellitus Type 2 Clinical Trial
Official 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
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.
The following will be assessed at Baseline and at the end of the treatment period;
1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will
be made after fasting for at least 6 hours in the same time of day at all visits. The
cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol,
with the total scan time at each visit estimated to 45 minutes. Images from all sites
will be analyzed centrally at the core-lab using a dedicated software package and
certified analysts.
2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as
fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be
made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least
6 hours at the same time of day at all visits.
- A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).
- A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The
subject is further examined by PET/CT over the liver, kidney cortex and brain (in
this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired
throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis
;
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