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Recruiting Phase 1 NCT07053319

SGLT2i, Pioglitazone, and Ketone Production in T2D

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Trial Parameters

Condition Type 2 Diabetes
Sponsor The University of Texas Health Science Center at San Antonio
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 64
Sex ALL
Min Age 30 Years
Max Age 75 Years
Start Date 2026-07-20
Completion 2027-06-01
Interventions
Empagliflozin 25 MG plus Pioglitazone placeboPioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin PlaceboEmpagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)

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Brief Summary

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

Patients with T2D Inclusion Criteria: * 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 * Blood Pressure (BP) \< 145/85 mmHg * Participants must be in general good health based on medical history, physical exam, screening blood chemistries, complete blood chemistry (CBC), thyroid stimulating hormone/thyroxine (TSH/T4), electrocardiogram (EKG), and urinalysis * Stable body weight (±1.5 kg) over the last 3 months and must not participate in an excessively heavy exercise program * Patients treated with diet, sulfonylurea (SU), metformin (MET), or SU/MET * Statin therapy is permissible if the dose has been stable for at least 3 months Exclusion Criteria: * 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 aff

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