NCT03190798

Effects of Canagliflozin on Intravascular Volume and Hemodynamics

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type2 Diabetes Mellitus
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Canagliflozin 300mg	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.
DRUG	Placebo	Placebo for Canagliflozin

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2017-06-19
• Last updated: 2017-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study