SGLT2i, Pioglitazone, and Ketone Production in T2D
ConditionType 2 Diabetes
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 years
Body Mass Index (BMI) 21-45 kg/m2
Hemoglobin A1C (HbA1c) = 7.0-11%
Estimated glomerular filtration rate (eGFR) > 60 ml/min/1.73m2
Disqualifiers
Patients treated with Glucagon-like peptide 1 receptor agonists (GLP-1 RA), Dipeptidyl Peptidase IV inhibitors (DPP-4i), Thiazolidinediones (TZD), or insulin are excluded
Patients taking medications (other than SU/MET) known to affect glucose metabolism are excluded
Subjects with evidence of proliferative retinopathy or eGFR < 60 are excluded
Women of childbearing potential are excluded unless they are taking/using appropriate contractive medications/devices
Trial design
Treatments tested in this trial
- Empagliflozin 25 MG plus Pioglitazone placebo
- Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo
- Empagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)
- Pioglitazone placebo + Empagliflozin placebo
Treatment groups
64 Participants
are divided into 4 treatment groupsSponsors 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
Source ClinicalTrials.gov