Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-03-21 @ 2:42 AM
Study NCT ID:
NCT00696995
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2008-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment
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': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Venous blood samples drawn as part of routine clinical evaluation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 509}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-06', 'studyFirstSubmitDate': '2008-06-11', 'studyFirstSubmitQcDate': '2008-06-11', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of serious adverse drug reactions, including major hypoglycaemic events', 'timeFrame': 'at 26 weeks'}], 'secondaryOutcomes': [{'measure': 'The number of all hypoglycaemic events', 'timeFrame': 'at 26 weeks'}, {'measure': 'HbA1c', 'timeFrame': 'at 12 weeks and 26 weeks'}, {'measure': 'Fasting plasma glucose at visits', 'timeFrame': 'at 12 weeks and 26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '22078072', 'type': 'RESULT', 'citation': 'Makela JK, Schmuser C, Askonen K, Saukkonen T. Starting or switching to biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes: a multicenter, observational, primary care study conducted in Finland. Diabetes Res Clin Pract. 2012 Jan;95(1):10-8. doi: 10.1016/j.diabres.2011.06.006. Epub 2011 Nov 9.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions when initiating or switching to insulin therapy with NovoMix® 30 in subjects with type 2 diabetes under normal clinical practice conditions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Type 2 diabetes\n* Insulin-naive or previously treated by basal only insulin therapy\n\nExclusion Criteria:\n\n* Patients who are unlikely to comply with the protocol\n* Pregnancy or breastfeeding or intention of becoming pregnant'}, 'identificationModule': {'nctId': 'NCT00696995', 'acronym': 'Start', 'briefTitle': 'An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'An Observational, Prospective Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix® 30 (Biphasic Insulin Aspart) Treatment', 'orgStudyIdInfo': {'id': 'BIASP-1917'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: biphasic insulin aspart 30']}], 'interventions': [{'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'otherNames': ['NovoMix® 30'], 'description': 'Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15110', 'city': 'Lahti', 'country': 'Finland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.98267, 'lon': 25.66151}}], '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'}}}}