Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00675220
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2008-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study to Assess the Efficacy and Safety of NovoRapid™ Flexpen™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 373}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2008-05-06', 'studyFirstSubmitQcDate': '2008-05-07', 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety profile of Insulin Aspart among Filipino patients', 'timeFrame': '1-month follow-up for outpatients; 1 month or upon discharge for inpatients whichever comes first'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2', 'Delivery Systems']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data in diabetic patients with acute hyperglycemia using NovoRapid™ FlexPen™ as per normal clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diabetes mellitus (according to product labelling)\n\nExclusion Criteria:\n\n* Hypoglycaemia\n* Hypersensitivity to insulin aspart or to any of the excipients (according to product labelling)'}, 'identificationModule': {'nctId': 'NCT00675220', 'briefTitle': 'Observational Study to Assess the Efficacy and Safety of NovoRapid™ Flexpen™', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Prospective, Open-Labelled, Non-Controlled, Observational Study to Assess the Efficacy and Safety of NovoRapid™ FlexPen™ in the Treatment of Acute Hyperglycemia: A Post-Marketing Surveillance Study', 'orgStudyIdInfo': {'id': 'ANA-1884'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: insulin aspart']}], 'interventions': [{'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1605', 'city': 'Manila', 'country': 'Philippines', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], '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'}}}}