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SGLT2 Inhibitor

Ertugliflozin for Diabetes & Heart Failure (EMMED-HF Trial)

Phase 4
Waitlist Available
Led By Trevor L Jenkins, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No HF hospitalization within 6 months
Age > 18 years old but < 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

EMMED-HF Trial Summary

This trial will see if a SGLTi2 inhibitor alters cardiac metabolism in people with HFpEF and DM2 compared to placebo.

Eligible Conditions
  • Type 2 Diabetes
  • Heart Failure

EMMED-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You haven't been hospitalized for heart failure in the last 6 months.
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You are between 18 and 75 years old.
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You are too heavy for your height, with a body mass index (BMI) between 29 and 42.

EMMED-HF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak VO2, ml/kg/Min, as Measured by Metabolic Gas Exchange
Secondary outcome measures
Left Ventricular Mass Index (gm/m2), as Measured by Cardiac MRI
Serum Ketone Bodies (Betahydroxybutyrate)

Side effects data

From 2017 Phase 3 trial • 621 Patients • NCT02033889
10%
Upper respiratory tract infection
10%
Back pain
9%
Hypoglycaemia
8%
Urinary tract infection
7%
Weight decreased
5%
Headache
5%
Influenza
5%
Arthralgia
4%
Cough
4%
Viral upper respiratory tract infection
1%
Peripheral ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ertugliflozin 15 mg
Placebo/Glimepiride
Ertugliflozin 5 mg

EMMED-HF Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ertugliflozin Treatment ArmExperimental Treatment1 Intervention
Ertugliflozin 5 mg tablet once a day for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet once a day for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ertugliflozin 5 mg
2013
Completed Phase 3
~5650

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,345 Total Patients Enrolled
Trevor L Jenkins, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Media Library

Ertugliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04071626 — Phase 4
Type 2 Diabetes Clinical Trial 2023: Ertugliflozin Highlights & Side Effects. Trial Name: NCT04071626 — Phase 4
Ertugliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04071626 — Phase 4
Type 2 Diabetes Research Study Groups: Placebo, Ertugliflozin Treatment Arm

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this scientific investigation include persons aged 55 or greater?

"Applicants aged between 18 and 75 are eligible to participate in this medical trial. Those younger than 18 have 215 other studies to choose from, while those over 65 can pick from 1,742 different clinical trials."

Answered by AI

How many participants are currently being recruited for this testing program?

"That is correct. According to the data hosted on clinicaltrials.gov, this medical trial which first began recruiting patients on March 1st 2020, is still actively searching for 52 participants at a single site."

Answered by AI

Are there existing vacancies for participants in this research study?

"That is correct. Clinicaltrials.gov records indicate that this trial, which kicked off on March 1st 2020, is still searching for participants. The study requires 52 individuals to be registered from a single site."

Answered by AI

Has the Food & Drug Administration sanctioned Ertugliflozin 5 mg?

"The safety of Ertugliflozin 5 mg scored a 3 in our assessment due to the Phase 4 trial status, which implies that this treatment has already been approved."

Answered by AI

Does this experiment constitute a pioneering venture?

"Research on Ertugliflozin 5 mg began in 2019 when MSD Korea Ltd. sponsored the initial 120-person trial. The drug subsequently received its Phase 3 approval and, presently, 8 trials for it are going on across 26 countries and 136 cities."

Answered by AI

Is it possible for me to participate in this research protocol?

"Eligibility for this medical research is limited to those aged 18-75 with a diagnosis of type 2 diabetes mellitus. The team are hoping to register 52 people in total."

Answered by AI

To what extent have researchers explored Ertugliflozin 5 mg's feasibility in clinical settings?

"Currently, there are 8 clinical trials researching Ertugliflozin 5 mg with 4 of them being in phase 3. In total, 221 sites across the United States have been identified as running studies for this medication, though Cleveland has a particularly high concentration of research centres."

Answered by AI
~2 spots leftby Mar 2025