Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-02-25 @ 5:43 PM
Study NCT ID:
NCT00597233
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
2008-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Insulin NPH and Insulin Aspart in Type 1 Diabetes
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'}], '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'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}], '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'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2008-01-09', 'studyFirstSubmitQcDate': '2008-01-09', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prandial blood glucose lowering profile', 'timeFrame': 'between 1st and 2nd post prandial hours'}], 'secondaryOutcomes': [{'measure': 'Hypoglycaemic events'}, {'measure': 'Adverse events'}, {'measure': 'Serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Cintora H, Rodrigues M, Klyver MI, Claus-Hermerg H, González G, Kanevsky D, Medrano G, Sánchez A. Insulina Aspártica versus insulina soluble humana: Estudio comparativo cruzado en pacientes con diabetes tipo 1. Revista de la Sociedad Argentina de Diabetes 2004; 38 (4): 218-224'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in South America. This aim of this trial is to evaluate the comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes for at least 12 months\n* Treatment with insulin NPH\n* Body Mass Index (BMI) below 30 kg/m2\n\nExclusion Criteria:\n\n* Total daily insulin dose greater than 1.40 IU/kg\n* Treatment with oral antidiabetic drugs (OADs)'}, 'identificationModule': {'nctId': 'NCT00597233', 'briefTitle': 'Human Insulin NPH and Insulin Aspart in Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'ANA-1529'}}, 'armsInterventionsModule': {'interventions': [{'name': 'insulin aspart', 'type': 'DRUG'}, {'name': 'soluble human insulin', 'type': 'DRUG'}, {'name': 'insulin NPH', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Junín', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.59391, 'lon': -60.94644}}], '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'}}}}