Treatment of Diabetes in Patients With Systolic Heart Failure

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT02920918
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Investigator Initiated Study to study the effects of Canagliflozin 100 milligrams (mg) vs Sitagliptin 100 mg on parameters of aerobic exercise capacity (peak oxygen consumption \[VO2\]) and ventilator efficiency (minute ventilation \[VE\]/carbon dioxide production \[VCO2\] slope) at cardiopulmonary exercise test (CPET) after 12 weeks of active treatment (primary endpoints). Blood pressure (BP), body water content, body composition, cardiac function, and diet will be also measured (secondary endpoints).

Key Dates

Start date
Oct 31, 2016
Status verified
Oct 2019
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Canagliflozin
    Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.
  • Active Comparator: Sitagliptin
    Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.

Primary Outcome Measure

Change From Baseline Aerobic Exercise Capacity at 12 Weeks [ Time Frame: baseline and 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298-

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