Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-27 @ 11:03 AM
Study NCT ID:
NCT00101751
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2005-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4877}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2005-01-12', 'studyFirstSubmitQcDate': '2005-01-12', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c and Incidence of hypoglycemia', 'timeFrame': 'After 24 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Postprandial glucose from 8-point SMBG spontaneously reported adverse events; any changes from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '22509859', 'type': 'DERIVED', 'citation': 'Trippe BS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Oyer DS. Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial). Curr Med Res Opin. 2012 Jul;28(7):1203-11. doi: 10.1185/03007995.2012.686444. Epub 2012 Jun 25.'}, {'pmid': '21741089', 'type': 'DERIVED', 'citation': 'Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Deluzio AJ, Chu PL, Trippe BS; Initiateplus Study Group. Efficacy and tolerability of self-titrated biphasic insulin aspart 70/30 in patients aged >65 years with type 2 diabetes: an exploratory post hoc subanalysis of the INITIATEplus trial. Clin Ther. 2011 Jul;33(7):874-83. doi: 10.1016/j.clinthera.2011.05.093. Epub 2011 Jul 8.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in the United States of America (USA). The purpose of this study is to compare the effectiveness and safety of a biphasic insulin aspart standard titration regimen when coupled with dietary intervention to standard titration without dietary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes'}, 'identificationModule': {'nctId': 'NCT00101751', 'acronym': 'INITIATE plus', 'briefTitle': 'INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of a Standard Titration Algorithm Coupled With a Conventional Dietary Intervention or Intensive Dietary Intervention Versus a Standard Titration Algorithm, Alone, in Patients With Type 2 Diabetes Initiating NovoLog® Mix 70/30 Therapy', 'orgStudyIdInfo': {'id': 'BIASP-2192'}}, 'armsInterventionsModule': {'interventions': [{'name': 'biphasic insulin aspart', 'type': 'DRUG'}, {'name': 'dietary regimen', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Clinical Trial Call Center', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}], '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'}}}}