Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure

NCT04071626 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY20190016
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will determine if subjects with heart failure with preserved ejection fraction (HFpEF) and type 2 diabetes mellitus (DM2) receiving sodium-glucose cotransporter 2 (SGLTi2) inhibitor therapy (ertugliflozin) alters cardiac metabolism compared to placebo in a single blinded (to subject), randomized, parallel group, active controlled, single center experimental design.

Conditions

Heart Failure, Diastolic; Diabetes Mellitus, Type 2

Keywords

ertugliflozin; SGLT2 inhibtion; Cardiovascular Diseases; Sodium-Glucose Transporter 2 Inhibitors; Glucose Metabolism Disorders; Physiological Effects of Drugs; Diabetes Mellitus; Diabetes Mellitus, Type 2; Endocrine System Diseases

Outcome Measures

Primary Outcomes (1)

• Peak VO2, ml/kg/Min, as Measured by Metabolic Gas Exchange

  The difference in peak oxygen uptake as measured by peak VO2 (ml/kg/min) between ertugliflozin and placebo as measured at baseline and after 12 weeks of treatment

  12 weeks

Secondary Outcomes (2)

• Left Ventricular Mass Index (gm/m2), as Measured by Cardiac MRI

  12 weeks

• Serum Ketone Bodies (Betahydroxybutyrate)

  12 weeks

Study Arms (2)

Ertugliflozin Treatment Arm

EXPERIMENTAL

Ertugliflozin 5 mg tablet once a day for 12 weeks

Drug: Ertugliflozin 5 mg

Placebo

PLACEBO COMPARATOR

Placebo tablet once a day for 12 weeks

Drug: Placebo oral tablet

Interventions

Ertugliflozin 5 mg DRUG

Ertugliflozin 5 mg once a day for 12 weeks

Ertugliflozin Treatment Arm

Placebo oral tablet DRUG

Placebo oral tablet once a day for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old but \< 75 years old
• No HF hospitalization within 6 months
• Overweight or Obesity defined as BMI \> 29 but \< 42
• History of insulin resistance or T2DM and on oral diabetes agents other than SGLT2i (HgbA1c \> 5.8% and \< 10.5%)
• EF calculated based on a recent echo/cath/nuclear study at screening (pre-enrollment) \> 50%
• Stable HFpEF (HF with preserved ejection fraction) medications use of 3 months with no plans to changes or add medications for at least 12 weeks course of the study)

You may not qualify if:

• Acute HFpEF hospitalization within 6 months of enrollment.
• CKD stage 4 or 5 (eGFR \< 30 ml/min by CKD-EPI equation).
• Other known causes of HF including poorly controlled hypertension (SBP \>160 mm Hg) or ischemic cardiomyopathy (etc).
• Anemia (Hgb \< 11.0 mg/dL for women and \< 12.0 mg/dL for men) or severe thrombocytopenia (platelets \< 50,000 mm3)
• Anticipated changing of HF medication during anticipated study period.
• HFREF (LV EF \< 50%).
• Acute coronary syndrome, transient ischemic attack, CVA or critical limb ischemia during the last 6 months or coronary/peripheral revascularization within the last 3 months. Severe life threatening illness or live expectancy \< 6 months.
• Contraindications to MRI (metallic implants, severe claustrophobia) or treadmill exercise (limb amputation, severe osteoarthritis or equivalent functional mechanical limitation).

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Endocrine System Diseases

Interventions

ertugliflozin

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Trevor Jenkins
• Organization: University Hospitals Cleveland Medical Center

Trevor.Jenkins@UHhospitals.org

(216)844-1229

Study Officials

• Trevor L Jenkins, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Single-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Department of Medicine, Case Western Reserve University / UH Cleveland Medical Center

Model Details: Parallel assignment, active controlled, single center experimental design.

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: March 1, 2020
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)