Back to search results

Empagliflozin and Type 2 Diabetes Study

This study is looking at how the medication Empagliflozin (used for type 2 diabetes) affects the body's production of ketones. Researchers want to understand if a combination of low body fluid (volume depletion) and low insulin levels (insulinopenia) is needed for Empagliflozin to increase glucose production from the liver and fat breakdown. You might be able to join if you are 30-75 years old, have type 2 diabetes with an HbA1c (a measure of blood sugar over time) between 7.0-11%, and generally good health. The main goal is to measure ketone body turnover (how quickly your body makes and uses ketones) at the start and after 300 minutes. The study plans to enroll 29 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 29 participants with type 2 diabetes. It involves several visits where participants will receive Empagliflozin.
What's involved
After an initial screening, you will have four additional study visits, or at least one of these four visits, starting at 6:00 AM at the Clinical Research Center. During these visits, you will receive infusions and have blood samples taken frequently over several hours.
Compensation
Not stated in the trial record.
Follow-up
Ketone body turnover will be measured at 0 and 300 minutes during the study visits.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07053306

SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia

Recruiting
PHASE1Ages 30–75InterventionalBasic science
The University of Texas Health Science Center at San Antonio
~29 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Empagliflozin 25 MG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ketone Body Turnover (ketogenesis)
Measured over 0 and 300 minutes

Conditions

Type 2 Diabetes

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Ralph DeFronzo, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

Who to contact

Ralph DeFronzo, MD
[email protected]
210-567-6691
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Ages 30-75
BMI (Body Mass Index) 21-45 kg/m2
HbA1c = 7.0-11%
eGFR (estimated glomerular filtration rate)\> 60 ml/min/1.73m2
Blood Pressure (BP)≤160/90 mmHg
Participants must be in general good health based on medical history, physical exam, screening blood chemistries, CBC (Complete Blood Count), TSH/T4 (thyroid/thyroxine hormone), EKG (electrocardiogram), and urinalysis (UA)
Stable body weight (±1.5 kg) over the last 3 months and must not participate in an excessively heavy exercise program
Patients treated with diet, Sulfonylureas, Metformin, or Sulfonylureas/Metformin (Sulfo/MET)
Participants receiving a Glucagon like peptide -1 receptor agonist (GLP1-RA) must be on a stable dose for at least three months prior to study enrollment.
Participants receiving a Dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitor) must be on a stable dose for at least two months prior to study enrollment.
SGLT2 inhibitors must be discontinued at least two months prior to study enrollment.
Statin therapy is permissible if the dose has been stable for at least 3 months

Exclusion

Patients treated with Thiazolidinediones (TZDs), or Insulin are excluded.
Patients taking medications other than Sulfonylureas/Metformin (SU/MET), stable dose of GLP1-RA and DPP4i known to affect glucose metabolism are excluded. Patients taking SGLT2i within 2 months of screening visit will be excluded from participating in this study, however they may be asked whether they would agree to discontinue the medication for two months to become eligible. (Please see clarification below.) \*
Subjects with evidence of proliferative retinopathy or estimated glomerular filtration rate (eGFR) \< 60 are excluded
Women of childbearing potential are excluded unless they are taking/using appropriate contractive medications/devices \* Only participants who are taking SGLT2 inhibitors during the prescreening period will be asked to discontinue the medication at least two months prior to the screening visit. If they agree, they will return for an HbA1c measurement four weeks after stopping the SGLT2 inhibitor.

What this trial measures

  • Ketone Body Turnover (ketogenesis)0 and 300 minutes

    Measurement of ketone body turnover rate during the baseline state and 240-300-minute time period, before and after Empagliflozin administration.