SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia

NCT07053306 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 20230457HU - 504076R01DK024092
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the 2-HIT hypothesis that the SGLT2i-induced stimulation of EGP, lipolysis, and ketone production requires the combination of volume depletion plus insulinopenia in T2D individuals.

Conditions

Type 2 Diabetes

Keywords

Pancreatic clamp; Endogenous glucose production; Ketogenesis; Gluconeogenesis; Lipolysis

Outcome Measures

Primary Outcomes (1)

• Ketone Body Turnover (ketogenesis)

  Measurement of ketone body turnover rate during the baseline state and 240-300-minute time period, before and after Empagliflozin administration.

  0 and 300 minutes

Study Arms (1)

Empagliflozin

EXPERIMENTAL

Empagliflozin 25 mg/day

Drug: Empagliflozin 25 MG

Interventions

Empagliflozin 25 MG 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.

Also known as: Jardiance

Empagliflozin

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \< 160/90 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Texas Diabetes Institute/UH

San Antonio, Texas, 78229-3900, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ralph DeFronzo, MD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralph DeFronzo, MD

CONTACT

210-567-6691; defronzo@uthscsa.edu

Aurora Merovci, MD

CONTACT

210-567-6691; merovci@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled 1 arm clinical trial comprised of 4 studies

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 8, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At study end after analysis of data.

Locations

US (1)