Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT01910194
Status:
COMPLETED
Last Update Posted:
2015-01-22
First Post:
2013-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-21', 'studyFirstSubmitDate': '2013-07-25', 'studyFirstSubmitQcDate': '2013-07-25', 'lastUpdatePostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCISEC(0-10min)', 'timeFrame': 'Within 0 to 10 min after iv glucose challenge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying', 'detailedDescription': 'Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 2 diabetes mellitus diagnosed at least one year before the screening visit not previously treated with glitazones, insulin or GLP-1 agonists\n* Inadequately controlled diabetes mellitus\n\nExclusion Criteria:\n\n* Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis'}, 'identificationModule': {'nctId': 'NCT01910194', 'briefTitle': 'Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying', 'organization': {'class': 'INDUSTRY', 'fullName': 'Profil Institut für Stoffwechselforschung GmbH'}, 'officialTitle': 'A Bicentric Open-label, Randomized, Two-parallel-group Study Investigating the Impact of Combined Lantus Insulin Glargine) and Lyxumia(Lixisenatide) on Insulin Secretion and Gastric Emptying in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled on Diet and Oral Antidiabetic Medication', 'orgStudyIdInfo': {'id': 'LanLyx'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lyxumia', 'description': '4 weeks Luxumia plus another 4 weeks combination', 'interventionNames': ['Drug: Luyxumia versus Lantus']}, {'type': 'OTHER', 'label': 'Lantus', 'description': '4 weeks Lantus plus another 4 weeks combination', 'interventionNames': ['Drug: Luyxumia versus Lantus']}], 'interventions': [{'name': 'Luyxumia versus Lantus', 'type': 'DRUG', 'armGroupLabels': ['Lantus', 'Lyxumia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'St. Josef-Hospital, University Hospital, Ruhr', '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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Profil Institut für Stoffwechselforschung GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}