Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-03-06 @ 1:44 PM
Study NCT ID:
NCT00576368
Status:
COMPLETED
Last Update Posted:
2008-01-09
First Post:
2007-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Therapeutic Project to Confirm the Efficacy Tolerability and Safety Profile of Lantus in Everyday Medical Practice
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': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4464}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-28', 'studyFirstSubmitDate': '2007-12-17', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic status (Fasting Blood Glucose, Fasting Plasma Glucose, and HbA1C as done in routine medical practice)', 'timeFrame': 'at least 3months'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The objective of this survey on this registered product is to confirm the efficacy, and safety profile of Lantus in every day medical practice. This program will also help to obtain information about the use of the insulin titration regimen and handling of the Lantus insulin analogue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All newly diagnosed diabetics and existing diabetics uncontrolled on other anti-diabetic therapy, where treatment with basal insulin is required to control hyperglycaemia, and who the treating investigator considers may benefit from the treatment with Lantus, could enter in this program.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00576368', 'briefTitle': 'An Open Therapeutic Project to Confirm the Efficacy Tolerability and Safety Profile of Lantus in Everyday Medical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open Therapeutic Project to Confirm the Efficacy Tolerability and Safety Profile of Lantus in Everyday Medical Practice', 'orgStudyIdInfo': {'id': 'HOE901_5007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: INSULIN GLARGINE']}], 'interventions': [{'name': 'INSULIN GLARGINE', 'type': 'DRUG', 'description': 'The physician will be guided by the prescribing information outlined in the summary of product characteristics. The administration will be done by once daily subcutaneous injection.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'E Hens', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}