Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02231658
Status:
TERMINATED
Last Update Posted:
2018-10-17
First Post:
2014-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'C479460', 'term': 'lixisenatide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'whyStopped': 'Too challenging to recruit appropriate participants at an acceptable speed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2014-09-01', 'studyFirstSubmitQcDate': '2014-09-03', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline (week -1) in the number of reflux episodes', 'timeFrame': '24 hours after 10 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus', 'timeFrame': 'After 10 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '32647054', 'type': 'DERIVED', 'citation': 'Quast DR, Schenker N, Menge BA, Nauck MA, Kapitza C, Meier JJ. Effects of Lixisenatide Versus Liraglutide (Short- and Long-Acting GLP-1 Receptor Agonists) on Esophageal and Gastric Function in Patients With Type 2 Diabetes. Diabetes Care. 2020 Sep;43(9):2137-2145. doi: 10.2337/dc20-0720. Epub 2020 Jul 9.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Male or female aged 18-65 years (both inclusive)\n* T2DM diagnosis\n\nExclusion Criteria:\n\n* Contraindications (including known or suspected hypersensitivity) to GLP-1 mimetics\n* Use of GLP-1 mimetics or DPP-IV inhibitors\n* Clinically relevant dysglycaemia as indicated by HbA1C ≥ 10%'}, 'identificationModule': {'nctId': 'NCT02231658', 'briefTitle': 'Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Profil Institut für Stoffwechselforschung GmbH'}, 'officialTitle': 'Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion', 'orgStudyIdInfo': {'id': 'GI-Motil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liraglutide', 'description': 'The highest injected once daily dose will be 1.8 mg s.c. for liraglutide.', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Lixisenatide', 'description': 'The highest injected once daily dose will be 20µg s.c. for lixisenatide.', 'interventionNames': ['Drug: Lixisenatide']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'armGroupLabels': ['Liraglutide']}, {'name': 'Lixisenatide', 'type': 'DRUG', 'armGroupLabels': ['Lixisenatide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'St. Josef-Hospital, Universitätsklinik', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Juris Meier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Josef Hospital Bochum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Profil Institut für Stoffwechselforschung GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}