RecruitingPhase 1NCT07053319

SGLT2i, Pioglitazone, and Ketone Production in T2D

Protocol lV: SGLT2 Inhibitors, Pioglitazone and Ketone Production in Type 2 Diabetes Mellitus


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

64 participants

Start Date

Jul 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).


Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study examines how combining SGLT2 inhibitors (a class of diabetes medications) with pioglitazone (another diabetes drug) affects the body's production of ketones — natural energy molecules. Researchers want to understand whether this combination is safe and how it influences energy metabolism in people with type 2 diabetes. **You may be eligible if...** - You have type 2 diabetes - You are currently taking an SGLT2 inhibitor - You are not using insulin - Your blood sugar is reasonably controlled - You meet the overall health requirements **You may NOT be eligible if...** - You have type 1 diabetes - You have significant heart failure, liver disease, or kidney impairment - You are currently taking pioglitazone - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEmpagliflozin 25 MG plus Pioglitazone placebo

A medication used in the management and treatment of type 2 diabetes mellitus. It is in the sodium-glucose co-transporter (SGLT-2) class of medications.

DRUGPioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo

Placebo-Inert tablet

DRUGEmpagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)

Pioglitazone, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the thiazolidinedione class of medications

DRUGPioglitazone placebo + Empagliflozin placebo

Placebo-Inert tablet


Locations(1)

Texas Diabetes Institute/UH

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07053319


Related Trials