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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Empagliflozin 25 MG plus Pioglitazone placebo
Drug
A medication used in the management and treatment of type 2 diabetes mellitus. It is in the sodium-glucose co-transporter (SGLT-2) class of medications.
Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo
Drug
Placebo-Inert tablet
Empagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)
Drug
Pioglitazone, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the thiazolidinedione class of medications
Pioglitazone placebo + Empagliflozin placebo
Drug
Placebo-Inert tablet

Treatment groups

64 Participants

are divided into 4 treatment groups

Group A: Empagliflozin plus Pioglitazone placeboExperimental treatment 1 intervention

Group B: Pioglitazone plus Empagliflozin PlaceboPlacebo comparator 1 intervention

Group C: Empagliflozin plus PioglitazoneExperimental treatment 1 intervention

Group D: Empagliflozin placebo + pioglitazone placeboExperimental treatment 0 interventions

Trial outcomes

Primary outcomes

Endogenous Glucose Production (EGP)

Measurement of Endogenous Glucose Production (EGP) using stable isotope (6,6, D2- glucose infusion).

Time frame

0 and 300 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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