SGLT2i, Pioglitazone, and Ketone Production in T1D

ConditionType1diabetes
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

T2DM

Daily insulin dose <0.6 U/kg per day

Fasting C-peptide >0.7 ng/ml

HbA1c <7.0% or >11.0%

Trial design

Treatments tested in this trial

  • Dapagliflozin 10mg Tab
  • Pioglitazone 15 MG and 30mg
  • Placebo

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The University of Texas Health Science Center at San Antonio

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator