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Treatment of Diabetes in Patients With Systolic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920918
Recruitment Status : Completed
First Posted : September 30, 2016
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Heart Failure, Systolic Diabetes Mellitus, Type 2 Drug: Canagliflozin Drug: Sitagliptin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure
Actual Study Start Date : October 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Canagliflozin
Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.
 Drug: Canagliflozin
Other Name: Invokana
Active Comparator: Sitagliptin
Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.
 Drug: Sitagliptin
Other Name: Januvia


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920918


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Janssen Scientific Affairs, LLC
Investigators
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Principal Investigator: Antonio Abbate, MD, PhD Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] December 8, 2016

More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02920918    
Other Study ID Numbers: HM20007043
28431754DIATBD ( Other Grant/Funding Number: Janssen Scientific Affairs )
First Posted: September 30, 2016    Key Record Dates
Results First Posted: October 29, 2019
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or a manuscript.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data were presented as late breaking clinical trial at the Heart Failure Society of America (HFSA) 2019 in Philadelphia as poster presentation.
Access Criteria: Data in the form of poster were made available from HFSA.
URL: https://www.eventscribe.com/2019/HFSA/PosterTitles.asp?pfp=PosterTitles
Keywords provided by Virginia Commonwealth University:
Systolic Heart Failure
Canagliflozin
Sitagliptin Phosphate
 Type 2 Diabetes
SGLT2 inhibitor
DPPIV inhibitor
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Systolic Murmurs
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Heart Murmurs
Sitagliptin Phosphate
 Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sodium-Glucose Transporter 2 Inhibitors