Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-01 @ 5:55 PM
Study NCT ID:
NCT01565733
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2012-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes
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'}]}, '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': 2223}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2012-03-26', 'studyFirstSubmitQcDate': '2012-03-26', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of severe hypoglycaemic episodes'}], 'secondaryOutcomes': [{'measure': 'Number of severe hypoglycaemic episodes'}, {'measure': 'Number of mild hypoglycaemic episodes'}, {'measure': 'Postprandial glucose concentration after breakfast, lunch, and dinner'}, {'measure': 'Average fasting glucose concentration after waking and before main meals'}, {'measure': 'Average plasma glucose level at bedtime and at night'}]}, '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 study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 diabetes requiring treatment with NovoMix® 30 insulin on admission who before hospitalisation had been treated with oral antidiabetics and/or human insulin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 2 diabetes\n* Treated with oral anti-diabetics and/or human insulin\n\nExclusion Criteria:\n\n* Persons previously included in the trial\n* Hypersensitive to biphasic insulin aspart or any of the excipients\n* Pregnant or lactating women, or those who plan to get pregnant within the next 12 months'}, 'identificationModule': {'nctId': 'NCT01565733', 'briefTitle': 'Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Multicenter, Open Label, Non-randomized, Non-interventional Observational Study of Safety of Treatment Initiation With a Biphasic Insulin Aspart (NovoMix® 30) in Hospitalized Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'BIASP-4017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NovoMix® 30 users', 'interventionNames': ['Drug: biphasic insulin aspart 30']}], 'interventions': [{'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'description': 'Biphasic insulin aspart 30 prescribed solely on the basis of clinical judgement. Initial dose, frequency of injections and further dosage amendments at the discretion of the treating physician.', 'armGroupLabels': ['NovoMix® 30 users']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL-02-274', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], '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'}}}}