SGLT2i, Pioglitazone, and Ketone Production in T1D

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07056699
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Type1diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Dapagliflozin (10 mg/day)
  • Pioglitazone 15 MG and 30mg — DRUG
    Pioglitazone (15 mg/day for 2 weeks, then 30 mg/day for 14 weeks)
  • Placebo — OTHER
    Inert placebo for Pioglitazone

Study Details

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 Type 1 Diabetes (T1D).

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental study drug for T1D
    Dapagliflozin (10 mg/day) + Pioglitazone (15 mg/day for 2 weeks, then 30 mg/day for 14 weeks)
  • Placebo Comparator: Placebo Group for T1D
    Dapagliflozin (10 mg/day) + Placebo (for 16 weeks)

Primary Outcome Measure

Change in endogenous glucose production (EGP) [ Time Frame: Baseline (Week 0) to Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Diabetes InstituteSan AntonioTexas78229-3900
Ralph Defronzo, MD
[email protected]
210-567-6691
Aurora Merovci, MD, MPH
[email protected]
210 358 7409

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By research site
Texas Diabetes Institute· San Antonio, TX

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