Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT00715351
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2008-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2008-07-11', 'studyFirstSubmitQcDate': '2008-07-11', 'lastUpdatePostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight change', 'timeFrame': 'at 3 months and 6 months after baseline'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemic events', 'timeFrame': 'at 3 months and 6 months after baseline'}, {'measure': 'Changes in glycaemic parameters', 'timeFrame': 'at 3 months and 6 months after baseline'}, {'measure': 'Safety parameters by collecting (serious) adverse events and the pregnancies.', 'timeFrame': 'at 3 months and 6 months after baseline'}, {'measure': 'Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I).', 'timeFrame': 'at 3 months and 6 months after baseline'}, {'measure': "Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II)", 'timeFrame': 'at 3 months and 6 months after baseline'}, {'measure': 'Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III).', 'timeFrame': 'at 3 months and 6 months after baseline'}, {'measure': 'Changes in doses', 'timeFrame': 'at 3 months and 6 months after baseline'}, {'measure': 'HbA1c', 'timeFrame': 'at 3 months and 6 months after baseline'}, {'measure': 'Changes in daily blood glucose values', 'timeFrame': 'at 3 months and 6 months after baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Insulin naïve patients with type 2 diabetes treated with oral antidiabetics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Previous use of insulin'}, 'identificationModule': {'nctId': 'NCT00715351', 'briefTitle': 'Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN304-1896'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: insulin detemir']}, {'label': 'B', 'interventionNames': ['Drug: insulin NPH']}], 'interventions': [{'name': 'insulin detemir', 'type': 'DRUG', 'description': 'Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician', 'armGroupLabels': ['A']}, {'name': 'insulin NPH', 'type': 'DRUG', 'description': 'Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SI-1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], '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'}}}}