Treatment of Diabetes in Patients With Systolic Heart Failure

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920918
• Other study ID #: HM20007043
• Secondary ID: 28431754DIATBD
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: October 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure
• Heart Failure, Systolic

Intervention

Drug:
• Canagliflozin

• Sitagliptin

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Aerobic Exercise Capacity at 12 Weeks	Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test	baseline and 12 weeks
Primary	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