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SGLT2i, Pioglitazone, and Ketone Production in Type 2 Diabetes

This study is looking at how two medications, empagliflozin and pioglitazone, affect people with Type 2 Diabetes. Empagliflozin is a sodium-glucose co-transporter (SGLT-2) inhibitor, and pioglitazone is a thiazolidinedione. Researchers want to see if pioglitazone can block certain effects of empagliflozin, specifically how the body produces glucose (sugar), breaks down fats, and makes ketones. 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 meet other health criteria like a healthy kidney function (eGFR > 60 ml/min/1.73m2). The study aims to understand these effects by measuring your body's glucose production.

Study design
This interventional study plans to enroll 64 participants. After an initial study day, participants will be randomly assigned to one of four groups for 10 weeks, receiving either empagliflozin, pioglitazone, both, or placebos.
What's involved
You would have an initial study day involving blood samples and ingesting empagliflozin. Following this, you would return to the clinic every 1-2 weeks for 10 weeks, and then repeat the initial study day at week 10.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Endogenous Glucose Production (EGP), is measured at 0 and 300 minutes during the study days. The study involves 10 weeks of treatment and follow-up 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.

NCT07053319

SGLT2i, Pioglitazone, and Ketone Production in T2D

Recruiting
PHASE1Ages 30–75InterventionalBasic science
The University of Texas Health Science Center at San Antonio
~64 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Empagliflozin 25 MGPioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin PlaceboEmpagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)

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).