Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-05 @ 2:30 AM
Study NCT ID:
NCT00592969
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2008-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 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': 'D008687', 'term': 'Metformin'}, {'id': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2004-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2008-01-02', 'studyFirstSubmitQcDate': '2008-01-02', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'after 12 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'PPBG values'}, {'measure': 'Glucose profiles'}, {'measure': 'Hypoglycemia'}, {'measure': 'Adverse events'}]}, '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 South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Currently treated with insulin NPH or are insulin-naive\n* Body mass index (BMI) below 35.0 kg/m2\n* HbA1c between 7.5-11.0%\n\nExclusion Criteria:\n\n* Participation in any other clinical trial involving investigational products within the last 3 months\n* History of drug or alcohol dependence\n* Known impaired hepatic function\n* Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition'}, 'identificationModule': {'nctId': 'NCT00592969', 'briefTitle': 'Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BIASP-1570'}}, 'armsInterventionsModule': {'interventions': [{'name': 'metformin', 'type': 'DRUG'}, {'name': 'biphasic insulin aspart', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5016', 'city': 'Mariano Acosta S/n', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '30150-320', 'city': 'Santa Efigênia', 'country': 'Brazil', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -9.27444, 'lon': -36.14111}}], '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'}}}}