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Empagliflozin and Glucose/Ketone Production in Type 2 Diabetes

This study is looking at how Empagliflozin, a medication for type 2 diabetes, affects how your body produces glucose (sugar) and ketones. Researchers want to understand the specific ways Empagliflozin works in people with type 2 diabetes. You might be eligible 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 have good kidney function (eGFR > 60). The study will compare Empagliflozin to a placebo (an inactive pill) to see its effects on glucose production. Success for this study means understanding the distinct ways Empagliflozin influences these body processes. The current recruitment status is unclear.

Study design
This is an interventional study with 30 participants, randomized to receive either Empagliflozin or a placebo in a 2:1 ratio.
What's involved
You would participate in two studies performed in random order, with 7-10 days between each study. This involves screening for general health, blood tests, and an EKG.
Compensation
Not stated in the trial record.
Follow-up
Endogenous Glucose Production (EGP) will be measured at 0 and 300 minutes during the study.

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

NCT05960656

SGLTi, Hepatic Glucose Production and Ketogenesis

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

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Endogenous Glucose Production (EGP)
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

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Do you actually qualify for this trial?

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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

  • Endogenous Glucose Production (EGP)0 and 300 minutes

    Measurement of Endogenous Glucose Production (EGP) using stable isotope (6,6, D2- glucose infusion).