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NCT07056699

SGLT2i, Pioglitazone, and Ketone Production in T1D

Recruiting
PHASE3Ages 18+InterventionalTreatment
The University of Texas Health Science Center at San Antonio
~24 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Dapagliflozin 10mg TabPioglitazone 15 MG and 30mgPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in endogenous glucose production (EGP)
Measured over Baseline (Week 0) to Week 16
+2 more outcomes measured

Conditions

Type1diabetes

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Muhammad Abdul-Ghani, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio
  • 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
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Eligibility criteria

Inclusion

The abnormality is not considered clinically significant.
The deviation does not pose a safety risk or interfere with study participation.
The rationale for inclusion is documented in the source records. 4. Fasting C-peptide concentration \<0.7 ng/ml 5. Poor glycemic control (HbA1c=7.0-11.0%) 6. Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump 7. Total daily insulin dose ≥0.6 U/kg per day 8. Stable insulin dose (±4 units) in the preceding three months 9. eGFR ≥ 50 ml/min 10. Weight stable over the preceding 3 months (± 4 pounds) 11. Positive GAD antibody (Glutamic Acid Decarboxylase antibody). \*
Testing for GAD antibodies will be performed during the screening visit. Participants who test positive for GAD antibodies will be eligible for enrollment in the study. Over time, these antibodies may disappear, reducing the likelihood of a positive result during screening. If participant tests negative for GAD antibodies, their medical history will be reviewed to determine whether testing for GAD antibodies was performed at an earlier stage of Type 1 Diabetes (T1D). If prior positive results are confirmed, the participant may be enrolled. If a participant tests positive for antibodies other than GAD, an exception request will be submitted to the Institutional Review Board (IRB) for approval.

What this trial measures

  • Change in endogenous glucose production (EGP)Baseline (Week 0) to Week 16

    Infusions of a tracer, ³H-glucose, will begin and continue until the end of the study. A single dose of empagliflozin (25 mg) by mouth will be taken at 900am. Blood samples will be collected minutes to assess how your body responds to the infused tracers. This tracer help to measure the rate of endogenous (liver) glucose production. The difference in levels of EGP will be reported from the beginning of the study to a second level taken 16 weeks later.

  • Change in ketone body production ( ketogenesis)Baseline (Week 0) to Week 16

    Infusions of tracers, ³H-glucose and U-2H-glycerol or 14C-Glycerol, will begin and continue until the end of the study. A single dose of empagliflozin (25 mg) by mouth will be taken at 900am. Blood samples will be collected to assess how your body responds to the infused tracers. This tracer help to measure the rate of ketone body production (ketogenesis). The difference in levels of ketones will be reported from the beginning of the study to a second level taken 16 weeks later.

  • Change in lipolysis (fat breakdown)Baseline (Week 0) to Week 16

    Infusions of tracers, U-H-14C-Glycerol or 2H-Glycerol, will begin and continue until the end of the study. A single dose of empagliflozin (25 mg) by mouth will be taken at 900am. Blood samples will be collected to assess how your body responds to the infused tracers. This tracer help to measure the rate of lipolysis (fat breakdown). The difference in levels of lipolysis will be reported from the beginning of the study to a second level taken 16 weeks later.