Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-29 @ 1:39 PM
Study NCT ID:
NCT00755833
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2008-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2008-09-18', 'studyFirstSubmitQcDate': '2008-09-18', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'At 0, 3, 6, 9, 12 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects achieving target HbA1c', 'timeFrame': 'At 0, 3, 6, 9, 12 months'}, {'measure': 'Change in FPG (fasting plasma glucose)', 'timeFrame': 'At 0, 3, 6, 9, 12 months'}, {'measure': 'Change in PPG (postprandial glucose)', 'timeFrame': 'At 0, 3, 6, 9, 12 months'}, {'measure': 'Change in number of hypoglycaemic events', 'timeFrame': 'At 0, 3, 6, 9, 12 months'}, {'measure': 'Change in insulin presentation', 'timeFrame': 'At 0, 3, 6, 9, 12 months'}, {'measure': 'Dose and number of injections', 'timeFrame': 'At 0, 3, 6, 9, 12 months'}, {'measure': 'Number of ADRs (adverse drug reaction)', 'timeFrame': 'At 0, 3, 6, 9, 12 months'}]}, '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 study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 diabetes patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 50 as new treatment and as part of routine out-patient care by the prescribing physician.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes treated with biphasic human insulin with or without metformin\n* Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50\n\nExclusion Criteria:\n\n* Subjects with diagnosed type 1 diabetes mellitus\n* Subjects treated with short acting or intermediate acting human insulin or any insulin analogue\n* Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits\n* Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients\n* Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months"}, 'identificationModule': {'nctId': 'NCT00755833', 'briefTitle': 'Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia', 'orgStudyIdInfo': {'id': 'BIASP-3674'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: biphasic insulin aspart 50']}], 'interventions': [{'name': 'biphasic insulin aspart 50', 'type': 'DRUG', 'otherNames': ['NovoMix® 50'], 'description': 'Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.', 'armGroupLabels': ['A']}]}, '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'}}}}