Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT02981966
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
    dapagliflozin, 10mg tablet
  • Placebo — DRUG
    Placebo for dapagliflozin

Study Details

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.

Key Dates

Start date
May 23, 2019
Status verified
Feb 2024
Primary completion
Apr 30, 2022
Completion
May 31, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: T2DM individuals on Dapagliflozin
    Individuals with type 2 diabetes mellitus - dapagliflozin
  • Placebo Comparator: T2DM individuals on Placebo
    Individuals with type 2 diabetes mellitus on placebo
  • Active Comparator: Normal Glucose Tolerance (NGT) on Dapagliflozin
    Individuals with normal glucose tolerance - dapagliflozin
  • Placebo Comparator: Normal Glucose Tolerance (NGT) Placebo
    Individuals with normal glucose tolerance - on placebo

Primary Outcome Measure

Endogenous Glucose Production Measurement [ Time Frame: 3 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Health Science CenterSan AntonioTexas78229-

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