- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02920918
Treatment of Diabetes in Patients With Systolic Heart Failure
A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Canagliflozin
Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.
|
Other Names:
|
Active Comparator: Sitagliptin
Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Aerobic Exercise Capacity at 12 Weeks
Time Frame: baseline and 12 weeks
|
Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test
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baseline and 12 weeks
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Change From Baseline Ventilatory Efficiency at 12 Weeks
Time Frame: baseline and 12 weeks
|
Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test
|
baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Heart Murmurs
- Heart Failure
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Systolic Murmurs
- Heart Failure, Systolic
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Sodium-Glucose Transporter 2 Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
- Canagliflozin
Other Study ID Numbers
- HM20007043
- 28431754DIATBD (Other Grant/Funding Number: Janssen Scientific Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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