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Trial record 21 of 61 for:    Lixisenatide

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

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ClinicalTrials.gov Identifier: NCT02231658
Recruitment Status : Terminated (Too challenging to recruit appropriate participants at an acceptable speed.)
First Posted : September 4, 2014
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Liraglutide Drug: Lixisenatide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
Actual Study Start Date : July 16, 2015
Actual Primary Completion Date : July 23, 2018
Actual Study Completion Date : July 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Liraglutide
The highest injected once daily dose will be 1.8 mg s.c. for liraglutide.
Drug: Liraglutide
Experimental: Lixisenatide
The highest injected once daily dose will be 20µg s.c. for lixisenatide.
Drug: Lixisenatide



Primary Outcome Measures :
  1. Change from baseline (week -1) in the number of reflux episodes [ Time Frame: 24 hours after 10 weeks of treatment ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231658


Locations
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Germany
St. Josef-Hospital, Universitätsklinik
Bochum, Germany, 44791
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Investigators
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Principal Investigator: Juris Meier, MD St. Josef Hospital Bochum

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Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT02231658     History of Changes
Other Study ID Numbers: GI-Motil
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Lixisenatide
Diabetes Mellitus
Gastroesophageal Reflux
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists