Treatment of Diabetes in Patients With Systolic Heart Failure

NCT02920918 | Completed Phase 4 Results

• 2 other identifiers: HM2000704328431754DIATBD
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure, Systolic; Diabetes Mellitus, Type 2

Keywords

Systolic Heart Failure; Canagliflozin; Sitagliptin Phosphate; Type 2 Diabetes; SGLT2 inhibitor; DPPIV inhibitor

Outcome Measures

Primary Outcomes (2)

• Change From Baseline Aerobic Exercise Capacity at 12 Weeks

  Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test

  baseline and 12 weeks

• Change From Baseline Ventilatory Efficiency at 12 Weeks

  Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test

  baseline and 12 weeks

Study Arms (2)

Canagliflozin

ACTIVE COMPARATOR

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

Drug: Canagliflozin

Sitagliptin

ACTIVE COMPARATOR

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

Drug: Sitagliptin

Interventions

Canagliflozin DRUG

Also known as: Invokana

Canagliflozin

Sitagliptin DRUG

Also known as: Januvia

Sitagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Diabetes Mellitus, Type 2

Interventions

Canagliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Triazoles; Azoles; Pyrazines

Results Point of Contact

• Title: Salvatore Carbone
• Organization: Virginia Commonwealth University

scarbone@vcu.edu

804 628 3980

Study Officials

• Antonio Abbate, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 30, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 29, 2019
• Results First Posted: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)