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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT03331289 (opens ClinicalTrials.gov in a new tab)Other idHSC20170582HOther idR01DK107680
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
107 participants (actual)
Sponsor
The University of Texas Health Science Center at San Antonio · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
28 Feb 2018
Primary completion
31 Mar 2022
Completion
4 Nov 2022
First posted
6 Nov 2017
Last update posted
24 Jul 2023
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020202120222023
  1. Ph 4

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

    NCT03331289

    28 Feb 2018 to 4 Nov 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • PlaceboDrug
  • ExenatideDrug
  • DapagliflozinDrug
  • Exenatide and DapagliflozinDrug

Arms4

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. 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]

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· From baseline [-35 to 0min] to the last hour post-glucose load [240-300 minutes]

Change in EGP From Baseline to Post-oral Glucose Load.

GroupValue (mg/kg.min)Spread
Placebo-0.030.02
Exenatide-0.180.02
Dapagliflozin0.140.03
Exenatide and Dapagliflozin-0.080.03

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebowe 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. Placebo: Placebo will be administered to 20 subjects after a 3 hour tracer equilibration period0 / 150 / 150 / 15
Exenatidewe 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. Exenatide: Exenatide will be administered to 20 subjects after a 3 hour tracer equilibration period0 / 250 / 254 / 25
Dapagliflozinwe 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. Dapagliflozin: Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period0 / 250 / 257 / 25
Exenatide and Dapagliflozinwe 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. Exenatide and Dapagliflozin: Exenatide and Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period0 / 250 / 256 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedAlatrach M, Agyin C, Solis-Herrera C, Lavryneko O, Adams J, Gastaldelli A, Triplitt C, DeFronzo RA, Cersosimo E. Dapagliflozin Impairs the Suppression of Endogenous Glucose Production in Type 2 Diabetes Following Oral Glucose. Diabetes Care. 2022 Jun 2;45(6):1372-1380. doi: 10.2337/dc21-1798. PMID 35235659

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Health Status: Type 2 Diabetes Mellitus according to ADA criteria (subjects must be in good general health as determined by physical exam, medical history, blood chemistry-CBC, TSH, T4, EKG and urinalysis) * BMI: 21-45kg/m * HbA1C\>7.0% and \<10.5% * Medication: Drug naïve and/or on a stable dose of metformin and/or sulfonylurea (more than 3 months) Exclusion Criteria: * Health Status: Type 1 Diabetics * Proliferative diabetic retinopathy * Plasma Creatinine greater than 1.4mg/dL in females or greater than 1.5mg/dL in males, or 24 hour urine albumin excretion greater than 300mg/dL * Medication: Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)

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