SGLT2i, Pioglitazone, and Ketone Production in T2D

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30-75
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).

Eligibility criteria

Qualifiers

Ages 30-75

BMI (Body Mass Index) 21-45 kg/m2

HbA1c = 7.0-11%

eGFR (estimated glomerular filtration rate)> 60 ml/min/1.73m2

Disqualifiers

Patients treated with Thiazolidinediones (TZDs), or Insulin are excluded.

Patients taking medications other than Sulfonylureas/Metformin (SU/MET), stable dose of GLP1-RA and DPP4i known to affect glucose metabolism are excluded. Patients taking SGLT2i within 2 months of screening visit will be excluded from participating in this study, however they may be asked whether they would agree to discontinue the medication for two months to become eligible. (Please see clarification below.) *

Subjects with evidence of proliferative retinopathy or estimated glomerular filtration rate (eGFR) < 60 are excluded

Women of childbearing potential are excluded unless they are taking/using appropriate contractive medications/devices * Only participants who are taking SGLT2 inhibitors during the prescreening period will be asked to discontinue the medication at least two months prior to the screening visit. If they agree, they will return for an HbA1c measurement four weeks after stopping the SGLT2 inhibitor.

Trial design

Treatments tested in this trial

  • Empagliflozin 25 MG
  • Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo
  • Empagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)

Treatment groups

64 Participants
are divided into 3 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