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NCT07053319 | RECRUITING | Type 2 Diabetes

SGLT2i, Pioglitazone, and Ketone Production in T2D
Sponsor:

The University of Texas Health Science Center at San Antonio

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).

Condition or disease

Type 2 Diabetes

Intervention/treatment

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

Phase

PHASE1

Detailed Description:

Participants: 64 T2D subjects with the same inclusion and exclusion criteria as Protocol 1. Subjects with hematuria are excluded. Study Design: Infusions of 3-3H-glucose and 14C-glycerol are started and continued to study end (2 PM). Baseline blood samples for HbA1c (x2) and for plasma insulin, glucagon, glucose, FFA, BHB, AcAc, glycerol, and plasma 3-3H-glucose and 14C-glycerol specific activities are drawn at -30, -20, -10, -5, and 0 minutes for measurement of lipolysis, ketone production (plasma ketone levels), and EGP. Empagliflozin (25 mg) is ingested at time zero (9AM) and plasma samples for the above are obtained every 10-20 minutes. Following completion of the above study, subjects will be randomized to one of four groups (16 per group) for 10 weeks: (1) empagliflozin, 25 mg/day, plus pioglitazone placebo; (2) pioglitazone, 15 mg/day, increased to 30 mg after 2 weeks plus empagliflozin placebo; (3) empagliflozin (25 mg/d) plus pioglitazone (15/30 mg/d); (4) empa placebo plus pio placebo. Subjects will return to the CRC every 1-2 weeks for interim medical history, to check medication compliance, and to measure plasma insulin, glucagon, glucose, FFA, glycerol, BHB, and AcAc levels. At week 10, subjects will return to the CRC at 6AM and the baseline study will be repeated. HbA1c will be measured twice during week 10.

Study Type : INTERVENTIONAL
Estimated Enrollment : 64 participants
Masking : TRIPLE
Masking Description : Subjects will be randomly assigned 1:1:1:1 ratio
Primary Purpose : BASIC_SCIENCE
Official Title : Protocol lV: SGLT2 Inhibitors, Pioglitazone and Ketone Production in Type 2 Diabetes Mellitus
Actual Study Start Date : 2026-07-20
Estimated Primary Completion Date : 2027-06-01
Estimated Study Completion Date : 2027-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 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
    • SGLT2i, Pioglitazone, and Ketone Production in T2D

    Location Details

    NCT07053319

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    Locations

    RECRUITING

    United States, Texas

    Texas Diabetes Institute/UH

    Saint Anthony, Texas, United States, 78229-3900