Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-05 @ 6:16 PM
Study NCT ID:
NCT00675493
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2008-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30
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': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 942}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2008-05-07', 'studyFirstSubmitQcDate': '2008-05-07', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c from baseline', 'timeFrame': 'For the duration of the study'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%', 'timeFrame': 'after 12 weeks and 24 weeks of treatment'}, {'measure': 'Change in FPG (glucose variability)', 'timeFrame': 'after 12 weeks and 24 weeks of treatment'}, {'measure': 'Change in PPG (postprandial control)', 'timeFrame': 'after 12 weeks and 24 weeks of treatment'}, {'measure': 'Change in insulin dose and number of injections', 'timeFrame': 'at 12 weeks and 24 weeks of treatment'}, {'measure': 'Change in oral antidiabetic drug therapy', 'timeFrame': 'after 12 weeks and 24 weeks of treatment'}, {'measure': 'Change in body weight', 'timeFrame': 'at 12 weeks and 24 weeks of treatment'}, {'measure': 'Change in number of hypoglycaemic events', 'timeFrame': 'during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment'}, {'measure': 'Number of adverse drug reactions (ADR)', 'timeFrame': 'after 12 weeks and 24 weeks of treatment'}]}, '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 trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 and type 2 diabetes patients inadequately controlled on human premixes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).\n\nExclusion Criteria:\n\n* Subjects currently being treated with biphasic insulin aspart 30\n* Subjects who were previously enrolled in this study\n* Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients\n* Women who are pregnant or have the intention of becoming pregnant within next 6 months\n* Children below 10 years of age'}, 'identificationModule': {'nctId': 'NCT00675493', 'briefTitle': 'Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Type 1 and Type 2 Diabetes Mellitus in Romania', 'orgStudyIdInfo': {'id': 'BIASP-3567'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: biphasic insulin aspart 30']}], 'interventions': [{'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'otherNames': ['NovoMix® 30'], 'description': 'Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010031', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], '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'}}}}