RecruitingPhase 3NCT07056699

SGLT2i, Pioglitazone, and Ketone Production in T1D

Protocol V: San Antonio Site Sub Study: Can Pioglitazone Block SGLT2 Inhibitor-induced Stimulation of Lipolysis, Ketone Production and Liver Glucose Production in Type I Diabetic Patients


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

24 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Participants are being asked to be in a research study. Scientists do research to answer important questions which might help change or improve treatment of participants disease in the future. In patients with Type 1 Diabetes (T1D), dapagliflozin a Selective Glucose Transporter 2 Inhibitor (SGLT2i) is known to increase production of glucose in the liver, increase breakdown of fats (lipolysis), and increase production of ketones (ketogenesis). Ketones are chemicals produced by the liver when the body breaks down fat for energy instead of glucose. When the level of ketones in the body becomes too high, a condition called ketoacidosis develops. In this study, the study team will investigate whether adding pioglitazone (a medication commonly used to treat type 2 diabetes), can reduce the dapagliflozin - induced liver glucose production, fat break down (lipolysis) and ketone body production (ketogenesis) in patients with T1D.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dapagliflozin 10mg Tab, a drug called Pioglitazone 15 MG and 30mg, and others for people with type1diabetes. The study is currently recruiting participants at 1 location.

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.

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Interventions

DRUGDapagliflozin 10mg Tab

Dapagliflozin (10 mg/day)

DRUGPioglitazone 15 MG and 30mg

Pioglitazone (15 mg/day for 2 weeks, then 30 mg/day for 14 weeks)

OTHERPlacebo

Inert placebo for Pioglitazone


Locations(1)

Texas Diabetes Institute

San Antonio, Texas, United States

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NCT07056699


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