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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial tests a medication that helps remove excess sugar from the body in patients with a specific type of heart failure and diabetes. The treatment aims to improve heart function by changing the heart's energy source to ketone bodies, which are more efficient and reduce stress on the heart.
Eligible Conditions
- Type 2 Diabetes
- Heart Failure
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Peak VO2, ml/kg/Min, as Measured by Metabolic Gas Exchange
Secondary study objectives
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 • NCT0203388911%
Upper respiratory tract infection
7%
Headache
7%
Hypoglycaemia
6%
Viral upper respiratory tract infection
5%
Influenza
4%
Cough
4%
Back pain
4%
Weight decreased
3%
Urinary tract infection
3%
Arthralgia
1%
Angina unstable
1%
Myocardial infarction
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo/Glimepiride
Ertugliflozin 5 mg
Ertugliflozin 15 mg
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
323 Previous Clinical Trials
342,835 Total Patients Enrolled
Trevor L Jenkins, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have heart failure due to poorly controlled high blood pressure or heart muscle damage from reduced blood flow.You cannot have an MRI if you have metal implants or are very claustrophobic. You cannot do treadmill exercise if you have an amputated limb, severe osteoarthritis, or other major physical limitations.You are expected to change your heart failure medication during the study.You have had a heart attack, stroke, or severe blood vessel blockage in the last 6 months, or you have had heart or blood vessel surgery in the last 3 months.You have a very serious illness that could be life-threatening or are not expected to live for more than 6 months.You have low levels of red blood cells (Hgb) or platelets in your blood.You have a condition where your heart doesn't pump blood effectively (left ventricular ejection fraction less than 50%).You have a history of insulin resistance or type 2 diabetes and are taking certain diabetes medications, but not SGLT2 inhibitors, and your HgbA1c level is between 5.8% and 10.5%.Your heart's pumping ability, measured in a recent test, is more than 50%.You haven't been hospitalized for heart failure in the last 6 months.You have been hospitalized for heart failure with preserved ejection fraction (HFpEF) in the past 6 months.You have severe kidney disease with very low kidney function.You are between 18 and 75 years old.You are too heavy for your height, with a body mass index (BMI) between 29 and 42.
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Ertugliflozin Treatment Arm
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