Phase 4
N=32
Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02981966 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Endogenous Glucose Production Measurement — 155; 121; 104; 98 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dapagliflozin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endogenous Glucose Production Measurement |
155; 121; 104; 98 | — |
| SECONDARY Renal Glucose Production Measurement of Change |
0.09; 0.01; 0.03; 0.03; 0.17; 0.03 | — |
Summary
Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in endogenous glucose production (EGP) following the induction of glucosuria (when glucose is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.
Eligibility Criteria
Inclusion Criteria
- 25-35 kg/m^2
- Normal Glucose Tolerance subjects (24)
- Type 2 Diabetic Subjects (24)
- Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
- Diabetic subjects must have HbA1c 1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded.
Data sourced from ClinicalTrials.gov (NCT02981966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.