Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 7:09 PM
Study NCT ID:
NCT01076634
Status:
COMPLETED
Last Update Posted:
2017-01-23
First Post:
2010-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two NN1250 Formulations in Subjects With 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': 'C571886', 'term': 'insulin degludec'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-20', 'studyFirstSubmitDate': '2010-02-24', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the glucose infusion rate curve during one dosing interval at steady-date"', 'timeFrame': 'After 8 days of treatment'}], 'secondaryOutcomes': [{'measure': 'Area under the serum Insulin Degludec concentration-time curve', 'timeFrame': 'During one dosing interval at steady state'}, {'measure': 'Area under the serum Insulin Degludec concentration-time curve', 'timeFrame': 'From 0 to 24 hours after single dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '23749405', 'type': 'RESULT', 'citation': 'Korsatko S, Deller S, Koehler G, Mader JK, Neubauer K, Adrian CL, Thomsen H, Haahr H, Pieber TR. A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200 U/mL formulations of ultra-long-acting insulin degludec. Clin Drug Investig. 2013 Jul;33(7):515-21. doi: 10.1007/s40261-013-0096-7.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months\n* Body mass index 18.0-28.0 kg/m\\^2 (both inclusive)\n\nExclusion Criteria:\n\n* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening\n* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)\n* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period'}, 'identificationModule': {'nctId': 'NCT01076634', 'briefTitle': 'Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN1250-3678'}, 'secondaryIdInfos': [{'id': '2009-014555-68', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1112-7714', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDeg 100 U/mL', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'EXPERIMENTAL', 'label': 'IDeg 200 U/mL', 'interventionNames': ['Drug: insulin degludec']}], 'interventions': [{'name': 'insulin degludec', 'type': 'DRUG', 'description': '0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.', 'armGroupLabels': ['IDeg 100 U/mL']}, {'name': 'insulin degludec', 'type': 'DRUG', 'description': '0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.', 'armGroupLabels': ['IDeg 200 U/mL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], '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'}}}}