Cardiovascular Diseases Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Mechanistic Study to Evaluate the Effects of Canagliflozin on Intravascular Volume and Hemodynamics in Subjects With Type 2 Diabetes Mellitus and Heart Failure
RESEARCH HYPOTHESIS
- In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for
the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4
weeks.
- Treatment with canagliflozin will be well tolerated over 4 weeks.
This is a randomized, double-blind, placebo-controlled, parallel-group, single-center study (Figure 1). Thirty subjects will be randomized in a 3:2 randomization ratio to canagliflozin 300 mg once daily (QD) or placebo. The study will include a 3-week pretreatment screening phase and a 4-week double-blind treatment phase. ;
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