SGLT2i, Pioglitazone, and Ketone Production in T1D (NCT07056699) | Clinical Trial Compass
Not Yet RecruitingPhase 3
SGLT2i, Pioglitazone, and Ketone Production in T1D
United States24 participantsStarted 2026-07-15
Plain-language 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 Type 1 Diabetes (T1D).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \>18 years
✓. T1DM
✓. Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG.
✓. Fasting C-peptide concentration \<0.7 ng/ml
✓. Poor glycemic control (HbA1c=7.0-11.0%)
✓. Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump
✓. Total daily insulin dose ≥0.6 U/kg per day
✓. Stable insulin dose (±4 units) in the preceding three months.
Exclusion criteria
✕. T2DM
✕. Daily insulin dose \<0.6 U/kg per day
✕. Fasting C-peptide \>0.7 ng/ml
What they're measuring
1
Change in endogenous glucose production (EGP)
Timeframe: Baseline (Week 0) to Week 16
2
Change in ketone body production ( ketogenesis)
Timeframe: Baseline (Week 0) to Week 16
3
Change in lipolysis (fat breakdown)
Timeframe: Baseline (Week 0) to Week 16
Trial details
NCT IDNCT07056699
SponsorThe University of Texas Health Science Center at San Antonio
✕. Pregnancy, lactating, positive pregnancy test or planning to become pregnant in the following year. Women of child-bearing potential will be requested to use at least two barrier methods before being enrolled in the study.
✕. Major organ system disease which includes: (i) malignancy or history of malignancy including bladder cancer; (ii) Congestive heart failure or history of coronary heart disease or any other cardiac disease; (iii) chronic liver disease or LFT \>3 times the upper normal level; (iv) History of alcohol or drug abuse; (v) History of chronic lung disease (e.g., COPD, asthma); (vi) history of rheumatic disease; (vii) History of chronic pancreatitis or pancreatic surgery; (viii) History of CVA or TIA (ix) Planned surgery during the study; (x) history of HIV infection or other immune compromised disease; and history of organ transplantation; (xi) patients who take medications, other than insulin, known to affect glucose metabolism, e.g., prednisone.