Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT00698269
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2008-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], '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'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5926}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2008-06-13', 'studyFirstSubmitQcDate': '2008-06-16', 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of major hypoglycaemic events reported', 'timeFrame': 'during 24 weeks of treatment'}, {'measure': 'Change in HbA1c', 'timeFrame': 'during 24 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects achieving HbA1c below 7.0%', 'timeFrame': 'at 12 & 24 weeks'}, {'measure': 'Change in FPG', 'timeFrame': 'at 12 & 24 weeks'}, {'measure': 'Change in PPG', 'timeFrame': 'at 12 & 24 weeks'}, {'measure': 'Body weight', 'timeFrame': 'at 12 & 24 weeks'}, {'measure': 'Change in number of hypoglycaemic events in the last 4 weeks before routine visits', 'timeFrame': 'at 12 & 24 weeks'}, {'measure': 'Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits', 'timeFrame': 'at 12 & 24 weeks'}, {'measure': 'Number of adverse drug reactions (ADR)', 'timeFrame': 'at 12 & 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A non-randomized sample of Type 1 or Type 2 diabetics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 or type 2 diabetes\n* Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®\n* Selection will be at the discretion of the individual physician\n\nExclusion Criteria:\n\n* Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®\n* Previous enrolled in this study\n* Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients\n* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months'}, 'identificationModule': {'nctId': 'NCT00698269', 'briefTitle': 'An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'INS-3532'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: insulin detemir']}, {'label': 'B', 'interventionNames': ['Drug: biphasic insulin aspart 30']}, {'label': 'C', 'interventionNames': ['Drug: insulin aspart']}], 'interventions': [{'name': 'insulin detemir', 'type': 'DRUG', 'otherNames': ['Levemir®'], 'description': 'Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation', 'armGroupLabels': ['A']}, {'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'description': 'Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation', 'armGroupLabels': ['B']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3542', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}