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Trial · Interventional

TerminatedPhase 1Registry data

Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion

NCTNCT02231658 (opens ClinicalTrials.gov in a new tab)Other idGI-Motil
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 1
Enrollment
109 participants (actual)
Sponsor
Profil Institut für Stoffwechselforschung GmbH · Industry
Design
Randomized · Single masking
Countries
1 country

Germany

Start
16 Jul 2015
Primary completion
23 Jul 2018
Completion
23 Jul 2018
First posted
4 Sept 2014 (estimated)
Last update posted
17 Oct 2018
Conditions
Diabetes Mellitus

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 1

    Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion

    NCT02231658

    16 Jul 2015 to 23 Jul 2018

    Terminated

Registry summary

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

The present study will compare lixisenatide and liraglutide in a population of subjects with T2DM not optimally controlled on OADs and / or insulin, which is the target population for these medications.

Interventions

  • LiraglutideDrug
  • LixisenatideDrug

Arms2

  • Experimental

    Liraglutide

    The highest injected once daily dose will be 1.8 mg s.c. for liraglutide.

  • Experimental

    Lixisenatide

    The highest injected once daily dose will be 20µg s.c. for lixisenatide.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from baseline (week -1) in the number of reflux episodes

    Time frame · 24 hours after 10 weeks of treatment

Secondary outcomes(1)

  1. Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus

    Time frame · After 10 weeks of treatment

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

10 results

Effects of Lixisenatide Versus Liraglutide (Short- and Long-Acting GLP-1 Receptor Agonists) on Esophageal and Gastric Function in Patients With Type 2 Diabetes.

Quast et al. 2020Diabetes carecited by 47

PMID 32647054DOI 10.2337/dc20-0720PUB-32647054

Rights unknown10 results
Source linkSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * Male or female aged 18-65 years (both inclusive) * T2DM diagnosis Exclusion Criteria: * Contraindications (including known or suspected hypersensitivity) to GLP-1 mimetics * Use of GLP-1 mimetics or DPP-IV inhibitors * Clinically relevant dysglycaemia as indicated by HbA1C ≥ 10%

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