Type2 Diabetes study: Empagliflozin
Official title SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
ClinicalTrials.gov ID: NCT05057806
What this study is testing
What is Empagliflozin 25 MG?
This is an investigational oral medicine being studied for people with type 2 diabetes and heart failure. It is designed to help the kidneys remove extra sugar from the blood through urine.
Also referred to as Jardiance.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how SGLT2 inhibitors and the ketones they raise affect muscle and heart use of ketones, muscle energy use, exercise ability, and how patients feel about their function.
- Who it's for
- Adults who have type 2 diabetes and heart failure with preserved ejection fraction.
- What's involved
- Participants will take an SGLT2 inhibitor and have blood tests for ketones, scans or tests to see how muscles and the heart use ketones, exercise tests, and fill out questionnaires about their daily function.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Type 2 Diabetes Mellitus
- Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50%
- Age 18-80 years
- BMI 23-38 kg/m2
- Glycated hemoglobin (HbA1c) 5.5-10%
You likely can't join if
- people treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
- Pregnancy, lactation or plans to become pregnant
- Allergy/sensitivity to study drugs or their ingredients
- Cancer
- Current drug or alcohol use or dependence
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
See the full eligibility criteria
- Type 2 Diabetes Mellitus
- Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50%
- Age 18-80 years
- BMI 23-38 kg/m2
- Glycated hemoglobin (HbA1c) 5.5-10%
- Blood Pressure (BP) ≤ 145/85 mmHg
- Estimated glomerular filtration rate (eGFR) ≥30 ml/min 1.73 m2
- Stable dose of guideline-directed medications for heart failure and Diabetes
- Stable body weight (±4 pounds) over the last 3 months
- Does not suffer from severe claustrophobia
- No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)
- people treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
- Pregnancy, lactation or plans to become pregnant
- Allergy/sensitivity to study drugs or their ingredients
- Cancer
- Current drug or alcohol use or dependence
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.