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SGLT2i, Pioglitazone, and Ketone Production in T1D

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Recruitment opened
    • Study description shortened, about 23 words
    • Eligibility criteria expanded, about 3 words
    v6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Eligibility criteria expanded, about 205 words
    • Site details revised
    v5
  3. Start date: Jul 15, 2026 to Jul 1, 2026v4
  4. Start date: Jan 30, 2026 to Jul 15, 2026v3
  5. Start date: Oct 15, 2025 to Jan 30, 2026v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07056699
Lead Sponsor The University of Texas Health Science Center at San Antonio
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Type1diabetes
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov