Treatment of Diabetes in Patients With Systolic Heart Failure

October 28, 2019 updated by: Virginia Commonwealth University

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).

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Canagliflozin
Other Names:
  • Invokana
Active Comparator: Sitagliptin
Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.
Drug: Sitagliptin
Other Names:
  • Januvia

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
baseline and 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Janssen Scientific Affairs, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)?

YES

IPD Plan Description

The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or a manuscript.

IPD Sharing Time Frame

Data were presented as late breaking clinical trial at the Heart Failure Society of America (HFSA) 2019 in Philadelphia as poster presentation.

IPD Sharing Access Criteria

Data in the form of poster were made available from HFSA.

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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