Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT01520818
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2012-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes
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'}, {'id': 'C575870', 'term': 'biphasic human insulin 30'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 666}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2001-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-03', 'studyFirstSubmitDate': '2012-01-25', 'studyFirstSubmitQcDate': '2012-01-25', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c (glycosylated haemoglobin A1c)'}], 'secondaryOutcomes': [{'measure': 'Blood glucose profiles'}, {'measure': 'Adverse events'}, {'measure': 'Hypoglycaemic episodes'}, {'measure': 'Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ)'}, {'measure': 'Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '18269638', 'type': 'RESULT', 'citation': 'Clements MR, Tits J, Kinsley BT, Rastam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008 Mar;10(3):229-37. doi: 10.1111/j.1463-1326.2006.00687.x.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 or Type 2 diabetes\n* Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents\n* Body mass index (BMI) maximum 40.0 kg/m\\^2\n\nExclusion Criteria:\n\n* History of drug or alcohol dependence\n* Impaired hepatic function\n* Impaired renal function\n* Cardiac disease\n* Proliferative retinopathy\n* Total daily insulin dose at least 1.80 IU/kg'}, 'identificationModule': {'nctId': 'NCT01520818', 'briefTitle': 'Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BIASP-1075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIAsp 50 or 70', 'interventionNames': ['Drug: biphasic insulin aspart 50', 'Drug: biphasic insulin aspart 70']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BHI 30', 'interventionNames': ['Drug: biphasic human insulin 30']}], 'interventions': [{'name': 'biphasic insulin aspart 50', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being obese with a body mass index (BMI) exceeding 30 kg/m\\^2 will receive BIAsp 50', 'armGroupLabels': ['BIAsp 50 or 70']}, {'name': 'biphasic insulin aspart 70', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m\\^2 will receive BIAsp 70', 'armGroupLabels': ['BIAsp 50 or 70']}, {'name': 'biphasic human insulin 30', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin), twice a day', 'armGroupLabels': ['BHI 30']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': 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