Phase 4
Completed N=36
Treatment of Diabetes in Patients With Systolic Heart Failure
Heart Failure, Systolic · Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02920918 ↗
Enrolled (actual)
36
Serious AEs
11.1%
Results posted
Oct 2019
Primary outcomePrimary: Change From Baseline Aerobic Exercise Capacity at 12 Weeks — 0.67; -0.53 mL/kg/min — p=0.083
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Aerobic Exercise Capacity at 12 Weeks |
0.67; -0.53 | 0.083 |
| PRIMARY Change From Baseline Ventilatory Efficiency at 12 Weeks |
-0.3; -0.3 | 0.51 |
Eligibility Criteria
Major Inclusion Criteria:
- Symptomatic stable heart failure (New York Heart Association (NYHA) functional classification II-III) with reduced left ventricular ejection fraction (LVEF) ≤40%
- Peak exercise limited by shortness of breath and associated with a respiratory exchange ratio (RER) >1.00 (reflecting maximal aerobic effort);
- Poorly controlled Type 2 Diabetes Mellitus (T2DM)(HbA1c levels between 7.0% and 10.0% if on a treatment regimen including insulin, or between 6.5% and 10.0% if not on an insulin regimen);
- Eighteen years of age or older.
Major Exclusion Criteria:
- Type I diabetes;
- Open label treatment with Sodium-GLucose coTransporter (SGLT)-2 inhibitors (within the past 3 months);
- Current treatment with thiazolidinedione (within the past 3 months);
- Chronic Renal Disease defined as Glomerular Filtration Rate (GFR) <50 ml•min-1/1.73m2 according to local laboratory
- Pregnancy or of child-bearing potential or lactating;
- Active or recent (within 2 weeks) genital/urinary infection;
- Concomitant conditions or treatment which would affect completion or interpretation of the study (i.e, physical inability to walk or run on a treadmill
- Inability to give informed consent.
Exclusion criteria specific to the cardiac magnetic resonance (CMR) substudy.
- Estimated GFR <60 ml•min-1/1.73m2
- Implantable cardioverter defibrillator, pacemaker or other implantable metal device not compatible with CMR scanning;
- Severe claustrophobia, inability to lay flat for up to 60 minutes, or other contraindication to CMR scanning.
Data sourced from ClinicalTrials.gov (NCT02920918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.