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NCT07056699

PHASE3

SGLT2i, Pioglitazone, and Ketone Production in T1D

Sponsor: The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-15

Completion Date

2027-06-30

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Type1diabetes

Interventions

DRUG

Dapagliflozin 10mg Tab

Dapagliflozin (10 mg/day)

DRUG

Pioglitazone 15 MG and 30mg

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

OTHER

Placebo

Inert placebo for Pioglitazone

Inclusion Criteria: 1. Age \>18 years 2. T1DM 3. Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG. 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≥60 ml/min 10. Weight stable over the preceding 3 months (± 3 pounds) and who do not participate in an excessively heavy exercise program Exclusion Criteria: 1. T2DM 2. Daily insulin dose \<0.6 U/kg per day 3. Fasting C-peptide \>0.7 ng/ml 4. HbA1c \<7.0% or \>11.0% 5. eGFR\<60 ml/min 6. Hematuria in urine analysis 7. 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. 8. 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. 9. Evidence of proliferative diabetic retinopathy 10. Patients enrolled in a heavy exercise program 11. Patients on ketogenic diet 12. History of hospitalization for DKA, hypoglycemia or uncontrolled hyperglycemia in the preceding 6 month. 13. Presence of symptoms of poor glycemic control, e.g. polydipsia or polyurea 14. History of hypersensitivity to dapagliflozin or pioglitazone

Locations (1)

Texas Diabetes Institute

San Antonio, Texas, United States