Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-01-08 @ 6:39 PM
Study NCT ID:
NCT01697618
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2012-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes
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'}, {'id': 'C575870', 'term': 'biphasic human insulin 30'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '1998-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-03', 'studyFirstSubmitDate': '2012-09-28', 'studyFirstSubmitQcDate': '2012-09-28', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the serum insulin curve'}], 'secondaryOutcomes': [{'measure': 'Overall shape of the 24 hour serum insulin profile'}, {'measure': 'Cmax (maximum plasma concentration)'}, {'measure': 'tmax (time to reach maximum)'}, {'measure': 'Area under the curve following each injections derived from 24 hours serum insulin profiles'}, {'measure': 'Overall shape of the 24 hour serum glucose profile'}, {'measure': 'Serum glucose excursions (EXC)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '12017398', 'type': 'RESULT', 'citation': 'McSorley PT, Bell PM, Jacobsen LV, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 2002 Apr;24(4):530-9. doi: 10.1016/s0149-2918(02)85129-3.'}], '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 pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes for at least 12 months\n* Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months\n* BMI (body mass index) below 39 kg/m\\^2\n* HbA1c (glycosylated haemoglobin) below 12%'}, 'identificationModule': {'nctId': 'NCT01697618', 'briefTitle': 'Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Double-blind, Single Centre, Two-way Cross-over Trial Comparing the Pharmacokinetics, Pharmacodynamics and Safety of the Biphasic Insulin Aspart 30 and Insulin Mixtard 30/70 After Multiple Dosing With a Twice Daily Dose Regimen in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'ANA/DCD/046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIAsp 30', 'interventionNames': ['Drug: biphasic insulin aspart 30', 'Drug: biphasic human insulin 30']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BHI 30', 'interventionNames': ['Drug: biphasic insulin aspart 30', 'Drug: biphasic human insulin 30']}], 'interventions': [{'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'description': 'Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs', 'armGroupLabels': ['BHI 30', 'BIAsp 30']}, {'name': 'biphasic human insulin 30', 'type': 'DRUG', 'description': 'Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs', 'armGroupLabels': ['BHI 30', 'BIAsp 30']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alphen aan den Rijn', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.12917, 'lon': 4.65546}}, {'zip': 'RH11 9RT', 'city': 'Crawley', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.11303, 'lon': -0.18312}}], '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'}}}}