Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00698802
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2008-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in 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': 'C575870', 'term': 'biphasic human insulin 30'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-13', 'studyFirstSubmitDate': '2008-06-16', 'studyFirstSubmitQcDate': '2008-06-16', 'lastUpdatePostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'after 8 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'For the duration of the trial'}, {'measure': 'Fructosamine', 'timeFrame': 'For the duration of the trial'}, {'measure': 'FPG', 'timeFrame': 'For the duration of the trial'}, {'measure': '4-point SMPG profiles', 'timeFrame': 'For the duration of the trial'}, {'measure': 'Incidence of hypoglycaemic episodes', 'timeFrame': 'For the duration of the trial'}, {'measure': 'Frequency and severity of adverse events (including injection site reactions)', 'timeFrame': 'For the duration of the trial'}, {'measure': 'Laboratory safety parameters (haematology, biochemistry and lipids)', 'timeFrame': 'For the duration of the trial'}, {'measure': 'Physical examination and vital signs', 'timeFrame': 'For the duration of the trial'}, {'measure': 'Total daily insulin dosages', 'timeFrame': 'For the duration of the trial'}]}, '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 Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes for at least 12 months\n* Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs\n* Body Mass Index (BMI) less than or equal to 40.0 kg/m2\n* HbA1c less than or equal to 9.5%\n* FPG (SMPG) less than or equal to 12 mmol/L\n\nExclusion Criteria:\n\n* Treatment with more than 1IU/kg insulin daily\n* Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors\n* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator\n* Known or suspected allergy to trial products or related products\n* Receipt of any investigational drug within one month prior to this trial\n* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers'}, 'identificationModule': {'nctId': 'NCT00698802', 'briefTitle': 'Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'EX1000-1919'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: EX1000']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: biphasic human insulin']}], 'interventions': [{'name': 'EX1000', 'type': 'DRUG', 'description': 'Treat-to-target titration scheme, s.c. injection', 'armGroupLabels': ['A']}, {'name': 'biphasic human insulin', 'type': 'DRUG', 'description': 'Treat-to-target titration scheme, s.c. injection', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '520002', 'city': 'Vijayawada', 'country': 'India', 'geoPoint': {'lat': 16.50745, 'lon': 80.6466}}, {'zip': '2193', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '51900', 'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], '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'}}}}