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SGLT2i, Pioglitazone, and Ketone Production in T2D

NCT07053319 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-05-12

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Empagliflozin 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.

DRUG

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

Placebo-Inert tablet

DRUG

Empagliflozin 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

DRUG

Pioglitazone placebo + Empagliflozin placebo

Placebo-Inert tablet

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Ralph DeFronzo, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-11
Primary Completion
2027-06-01
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07053319 on ClinicalTrials.gov