CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 107 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03331289
NCT03331289Phase 4Completed
CompareCT.gov

SGLT2 INHIBITION AND STIMULATION OF ENDOGENOUS GLUCOSE PRODUCTION [EGP]: Can the Glucagon-like Peptide-1 [GLP-1] Receptor Agonist, Exenatide, Prevent the Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria

The University of Texas Health Science Center at San Antonio·interventional·Posted Nov 6, 2017·Updated Jul 24, 2023

In Brief

A Phase 4 clinical trial evaluating Placebo, Exenatide, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 107 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedNov 6, 2017
Enrollment StartFeb 28, 2018
Primary CompletionMar 31, 2022
Study CompletionNov 4, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.7 years ago

Interventions

Placebodrug

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

Exenatidedrug

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

Dapagliflozindrug

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

Exenatide and Dapagliflozindrug

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