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
- Diabetes Mellitus, Type 2
- Heart Failure, Systolic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Canagliflozin — DRUG
- Sitagliptin — DRUG
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: CanagliflozinCanagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.
- Active Comparator: SitagliptinSitagliptin 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | - |
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