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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Canagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works by decreasing the amount of sugar the body absorbs, and increasing the amount of sugar that leaves the body in the urine. Administered in 300mg tablets.
Placebo for Canagliflozin
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Change in Pulmonary capillary wedge pressure (PCWP)
The primary efficacy endpoint will be change in PCWP from baseline to end of acute administration monitoring period (6 hours).
Time frame: 6 hours
Change in Pulmonary capillary wedge pressure (PCWP)
The key secondary endpoint will be change in PCWP from baseline to 4 weeks.
Time frame: 4 weeks
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