search
Back to results

Treatment of Diabetes in Patients With Systolic Heart Failure

Primary Purpose

Heart Failure, Systolic, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Canagliflozin
Sitagliptin
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Systolic Heart Failure, Canagliflozin, Sitagliptin Phosphate, Type 2 Diabetes, SGLT2 inhibitor, DPPIV inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Canagliflozin

Sitagliptin

Arm Description

Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.

Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline Aerobic Exercise Capacity at 12 Weeks
Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test
Change From Baseline Ventilatory Efficiency at 12 Weeks
Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test

Secondary Outcome Measures

Full Information

First Posted
September 22, 2016
Last Updated
October 28, 2019
Sponsor
Virginia Commonwealth University
Collaborators
Janssen Scientific Affairs, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT02920918
Brief Title
Treatment of Diabetes in Patients With Systolic Heart Failure
Official Title
A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Janssen Scientific Affairs, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic, Diabetes Mellitus, Type 2
Keywords
Systolic Heart Failure, Canagliflozin, Sitagliptin Phosphate, Type 2 Diabetes, SGLT2 inhibitor, DPPIV inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canagliflozin
Arm Type
Active Comparator
Arm Description
Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.
Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Description
Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Other Intervention Name(s)
Invokana
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Primary Outcome Measure Information:
Title
Change From Baseline Aerobic Exercise Capacity at 12 Weeks
Description
Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test
Time Frame
baseline and 12 weeks
Title
Change From Baseline Ventilatory Efficiency at 12 Weeks
Description
Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Abbate, MD, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.eventscribe.com/2019/HFSA/PosterTitles.asp?pfp=PosterTitles

Learn more about this trial

Treatment of Diabetes in Patients With Systolic Heart Failure

We'll reach out to this number within 24 hrs