RecruitingPhase 1NCT07053319

SGLT2i, Pioglitazone, and Ketone Production in T2D

Protocol lV: SGLT2 Inhibitors, Pioglitazone and Ketone Production in Type 2 Diabetes Mellitus

Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

64 participants

Start Date

Jul 20, 2026

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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

Min Age: 30 YearsMax Age: 75 Years

Inclusion Criteria10

Patients with T2D
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 Criteria4

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

Interventions

DRUGEmpagliflozin 25 MG plus Pioglitazone placebo

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.

DRUGPioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo

Placebo-Inert tablet

DRUGEmpagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)

Pioglitazone, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the thiazolidinedione class of medications

DRUGPioglitazone placebo + Empagliflozin placebo

Placebo-Inert tablet