SGLT2i, Pioglitazone, and Ketone Production in T2D

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07053319
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
May 11, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Empagliflozin plus Pioglitazone placebo
    Empagliflozin 25 mg/day plus pioglitazone placebo
  • Placebo Comparator: Pioglitazone plus Empagliflozin Placebo
    Pioglitazone, 15 mg/day, increased to 30 mg after 2 weeks plus empagliflozin placebo
  • Experimental: Empagliflozin plus Pioglitazone
    Empagliflozin(25mg/day) plus pioglitazone (15/30 mg/d)
  • Experimental: Empagliflozin placebo + pioglitazone placebo
    empagliflozin placebo plus pioglitazone placebo

Primary Outcome Measure

Endogenous Glucose Production (EGP) [ Time Frame: 0 and 300 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Diabetes Institute/UHSan AntonioTexas78229-3900
Ralph DeFronzo, MD
210-358-7200
Aurora Merovci, MD
210-567-6691
Ralph DeFronzo, MD (PRINCIPAL_INVESTIGATOR)

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