Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-15 @ 4:24 PM
Study NCT ID:
NCT00600366
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2008-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia']}, '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2008-01-14', 'studyFirstSubmitQcDate': '2008-01-14', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'after 12 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Blood glucose profiles'}, {'measure': 'Incidence of hypoglycaemic episodes'}, {'measure': 'Incidence of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '18001251', 'type': 'RESULT', 'citation': 'Lalic NM, Micic D, Antic S, Bajovic L, Pantelinac P, Jotic A, Kendereski A, Dimic D, Djukic A, Mitrovic M, Vujasin M. Effect of biphasic insulin aspart on glucose and lipid control in patients with Type 2 diabetes mellitus. Expert Opin Pharmacother. 2007 Dec;8(17):2895-901. doi: 10.1517/14656566.8.17.2895.'}], '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 investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Insulin naive diabetes\n* Current treatment with OHA, secondary failure\n* Body mass index (BMI) below 40 kg/m2\n* HbA1c over 8.5%\n* Willing and able to start with insulin therapy and to perform self-blood glucose monitoring\n\nExclusion Criteria:\n\n* History of drug or alcohol abuse\n* Receipt of the investigational drug within the last month prior to this trial\n* Known or suspected allergy to trial products or related products\n* Severe uncontrolled hypertension\n* Any disease or condition, which the Investigator feels, would interfere with the trial'}, 'identificationModule': {'nctId': 'NCT00600366', 'briefTitle': 'Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure', 'orgStudyIdInfo': {'id': 'BIASP-1566'}}, 'armsInterventionsModule': {'interventions': [{'name': 'biphasic insulin aspart', 'type': 'DRUG', 'otherNames': ['BIASP', 'NovoMix 30', 'NovoLog 70/30 Mix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia and Montenegro', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '34000', 'city': 'Kragujevac', 'country': 'Serbia and Montenegro', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '18000', 'city': 'Nis', 'country': 'Serbia and Montenegro', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia and Montenegro', 'facility': 'Novo Nordisk Investigational Site'}], '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'}}}}