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
- Empagliflozin 25 MG plus Pioglitazone placebo — DRUGA 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.
- Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo — DRUGPlacebo-Inert tablet
- Empagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d) — DRUGPioglitazone, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the thiazolidinedione class of medications
- Pioglitazone placebo + Empagliflozin placebo — DRUGPlacebo-Inert tablet
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 placeboEmpagliflozin 25 mg/day plus pioglitazone placebo
- Placebo Comparator: Pioglitazone plus Empagliflozin PlaceboPioglitazone, 15 mg/day, increased to 30 mg after 2 weeks plus empagliflozin placebo
- Experimental: Empagliflozin plus PioglitazoneEmpagliflozin(25mg/day) plus pioglitazone (15/30 mg/d)
- Experimental: Empagliflozin placebo + pioglitazone placeboempagliflozin placebo plus pioglitazone placebo
Primary Outcome Measure
Endogenous Glucose Production (EGP) [ Time Frame: 0 and 300 minutes ]
Central Contacts
- Ralph DeFronzo, MD210-567-6691
- Aurora Merovci, MD210-567-6691
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Texas Diabetes Institute/UH | San Antonio | Texas | 78229-3900 | Ralph DeFronzo, MD (PRINCIPAL_INVESTIGATOR) |
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