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NCT03331289

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

Completed Phase 4 Results posted Last updated 24 July 2023
What this trial tests

Phase 4 trial testing Placebo in Diabetes Mellitus, Type 2 in 107 participants. Completed in 4 November 2022.

Timeline
28 February 2018
Primary endpoint
31 March 2022
4 November 2022

Quick facts

Lead sponsorThe University of Texas Health Science Center at San Antonio
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment107
Start date28 February 2018
Primary completion31 March 2022
Estimated completion4 November 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Health Science Center at San Antonio

Who can join

Adults 18 to 70, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

The difference in rate of EGP during the last hour of the study (from 240-300 minutes) between drug-treatment and placebo treatment studies represents the effect of drug treatment on EGP, which will be compared among the 3 acute drug treatments (exenatide; dapagliflozin; exenatide plus dapagliflozin this data includes change in EGP above baseline following dapagliflozin alone vs dapagliflozin/exenatide) with ANOVA.

GroupValue95% CI
Placebo-0.03± 0.02
Exenatide-0.18± 0.02
Dapagliflozin0.14± 0.03
Exenatide and Dapagliflozin-0.08± 0.03

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 0/15 (0%)
Deaths: 0/15
Exenatide
Serious: 0/25 (0%)
Deaths: 0/25
Dapagliflozin
Serious: 0/25 (0%)
Deaths: 0/25
Exenatide and Dapagliflozin
Serious: 0/25 (0%)
Deaths: 0/25
Other adverse events (2 terms — click to expand)

ReactionSystemPlaceboExenatideDapagliflozinExenatide and Dapagliflozin
Genital MycosisInfections and infestations
Nausea and VomitingGastrointestinal disorders

Data from ClinicalTrials.gov NCT03331289 adverse events section.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Dapagliflozin Impairs the Suppression of Endogenous Glucose Production in Type 2 Diabetes Following Oral Glucose.
    Alatrach M, Agyin C, Solis-Herrera C, Lavryneko O, et al · · 2022 · cited 7× · PMID 35235659 · DOI 10.2337/dc21-1798
  2. Emergence of a New Glucoregulatory Mechanism for Glycemic Control With Dapagliflozin/Exenatide Therapy in Type 2 Diabetes.
    Cersosimo E, Alatrach M, Solis-Herrera C, Baskoy G, et al · · 2023 · cited 5× · PMID 37481263 · DOI 10.1210/clinem/dgad438

Verify or expand the search:

Other trials of Exenatide

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other The University of Texas Health Science Center at San Antonio trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03331289.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing