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Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure

NCT04071626 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-12-13

Study results available
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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

Interventions

DRUG

Ertugliflozin 5 mg

Ertugliflozin 5 mg once a day for 12 weeks

DRUG

Placebo oral tablet

Placebo oral tablet once a day for 12 weeks

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Trevor L Jenkins, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2023-01-11
Completion
2023-01-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071626 on ClinicalTrials.gov