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

NCT03331289 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2023-07-24

Study results available
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Summary

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

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Placebo will be administered to 20 subjects after a 3 hour tracer equilibration period

DRUG

Exenatide

Exenatide will be administered to 20 subjects after a 3 hour tracer equilibration period

DRUG

Dapagliflozin

Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period

DRUG

Exenatide and Dapagliflozin

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2022-03-31
Completion
2022-11-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03331289 on ClinicalTrials.gov