Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure
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).
Investigator Initiated Study: Randomized, double-blinded, active-control clinical trial to
determine the safety and efficacy of Canagliflozin and Sitagliptin in patients with type 2
diabetes and systolic heart failure (HF).
The investigators propose to study the effects of Canagliflozin 100 mg vs Sitagliptin 100 mg
(both administered once daily for 12 weeks) on parameters of aerobic exercise capacity and
ventilator efficiency by CPET after 12 weeks of active treatment. BP, body water content
(Bioelectrical Impedance Analysis [BIA]), body composition (Dual-energy X-ray absorptiometry
[DEXA]), cardiac function, diet and biomarkers will be also measured. Subjects with evidence
of left ventricular hypertrophy will undergo cardiac magnetic resonance (CMR) imaging.
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