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
The University of Texas Health Science Center at San Antonio
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 T1D.
Description
The purpose of this research study is to investigate the effects of dapagliflozin and pioglitazone in the body - specifically, on liver glucose production, breakdown of fat, and ketone production in T1D patients treated with insulin. Subjects with T1D can't make insulin because their pancreas doesn't work properly. This means they need insulin injections to control their blood sugar. But using insulin can sometimes cause low blood sugar and weight gain, making it harder for insulin to work and requiring higher doses. Finding other medicines that can help lower blood sugar in people with T1D an…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA 1. Age \>18 years 2. T1D 3. Other than diabetes, subjects must be in good general health as determined by the investigator based on physical exam, medical history and screening labs. Minor deviations may be permitted if: * 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 injec…
Interventions
- DrugDapagliflozin 10mg Tab
Dapagliflozin (10 mg/day)
- DrugPioglitazone 15 MG and 30mg
Pioglitazone (15 mg/day for 2 weeks, then 30 mg/day for 14 weeks)
- OtherPlacebo
Inert placebo for Pioglitazone
Location
- Texas Diabetes InstituteSan Antonio, Texas