Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT03331289
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    Placebo will be administered to 20 subjects after a 3 hour tracer equilibration period
  • Exenatide — DRUG
    Exenatide will be administered to 20 subjects after a 3 hour tracer equilibration period
  • Dapagliflozin — DRUG
    Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
  • Exenatide and Dapagliflozin — DRUG
    Exenatide and Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period

Study Details

Research Design/Plan: After screening, each subject will receive 1 measurements of Endogenous Glucose Production \[EGP\] with prime-continuous Infusion of 3-3H-glucose. After completing the EGP measurement each subject will receive a Double Tracer Oral Glucose Tolerance Test \[OGTT\]. Methods: Visit 1: Screening. Medical history will be obtained, physical exam performed, and pregnancy test performed. Visit 2: Endogenous Glucose Production Measurement: The rate of EGP will be measured with 3-3H-glucose. Visit 3: Double Tracer OGTT

Key Dates

Start date
Feb 28, 2018
Status verified
Jul 2023
Primary completion
Mar 31, 2022
Completion
Nov 4, 2022

Study Design

Enrollment
107 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo
    we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
  • Active Comparator: Exenatide
    we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
  • Active Comparator: Dapagliflozin
    we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
  • Active Comparator: Exenatide and Dapagliflozin
    we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.

Primary Outcome Measure

Change in EGP From Baseline to Post-oral Glucose Load. [ Time Frame: From baseline [-35 to 0min] to the last hour post-glucose load [240-300 minutes] ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Health System Texas Diabetic InstituteSan AntonioTexas78207-

Find similar trials in San Antonio, TX

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University Health System Texas Diabetic Institute· San Antonio, TX

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