Treatment of Diabetes in Patients With Systolic Heart Failure

NCT ID: NCT02920918

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-09-30

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.

Conditions

Heart Failure, Systolic; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Canagliflozin

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

Group Type: ACTIVE_COMPARATOR

Canagliflozin

Intervention Type: DRUG

Sitagliptin

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

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

Interventions

Canagliflozin

Intervention Type: DRUG

Sitagliptin

Intervention Type: DRUG

Other Intervention Names

Invokana; Januvia

Eligibility Criteria

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.

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Abbate, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

28431754DIATBD

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM20007043

Identifier Type: -

Identifier Source: org_study_id