| Trial ID: | L4599 |
| Source ID: | NCT02920918
|
| Associated Drug: |
Canagliflozin
|
| Title: |
Treatment of Diabetes in Patients With Systolic Heart Failure
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02920918/results
|
| Conditions: |
Heart Failure, Systolic|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Canagliflozin|DRUG: Sitagliptin
|
| Outcome Measures: |
Primary: Change From Baseline Aerobic Exercise Capacity at 12 Weeks, Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test, baseline and 12 weeks|Change From Baseline Ventilatory Efficiency at 12 Weeks, Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test, baseline and 12 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Virginia Commonwealth University | Collaborators: Janssen Scientific Affairs, LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-10
|
| Completion Date: |
2018-09
|
| Results First Posted: |
2019-10-29
|
| Last Update Posted: |
2019-10-29
|
| Locations: |
Virginia Commonwealth University, Richmond, Virginia, 23298, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02920918
|