Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-03 @ 9:34 PM
Study NCT ID:
NCT01868568
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2013-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected 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'}, {'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}], '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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2013-05-30', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the insulin aspart concentration curve', 'timeFrame': '0-2 hours after dosing'}], 'secondaryOutcomes': [{'measure': 'Area under the glucose infusion rate curve', 'timeFrame': '0-26 hours after dosing'}, {'measure': 'Area under the serum insulin 454 concentration curve', 'timeFrame': '0-120 hours after dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'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 compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results\n* Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months\n* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\\^2 (both inclusive)\n\nExclusion Criteria:\n\n* A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the Investigator\n* A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies\n* A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing'}, 'identificationModule': {'nctId': 'NCT01868568', 'briefTitle': 'Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Double-blind, Multiple Period Cross-over Trial Comparing Insulin 454 and Insulin Aspart Fixed Combination Products With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared to Biphasic Insulin Aspart 30 (NovoMix® 30) in Subjects With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN5401-1959'}, 'secondaryIdInfos': [{'id': '2007-006110-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDegAsp 30 + placebo', 'interventionNames': ['Drug: insulin degludec/insulin aspart 30', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin aspart + insulin degludec - low concentration 1', 'interventionNames': ['Drug: insulin degludec', 'Drug: insulin aspart']}, {'type': 'EXPERIMENTAL', 'label': 'IDegAsp 40 + placebo', 'interventionNames': ['Drug: insulin degludec/insulin aspart 40', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin aspart + insulin degludec - high concentration 1', 'interventionNames': ['Drug: insulin degludec', 'Drug: insulin aspart']}, {'type': 'EXPERIMENTAL', 'label': 'IDegAsp 45 + placebo', 'interventionNames': ['Drug: insulin degludec/insulin aspart 45', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin aspart + insulin degludec', 'interventionNames': ['Drug: insulin degludec', 'Drug: insulin aspart']}, {'type': 'EXPERIMENTAL', 'label': 'IDegAsp 55 + placebo', 'interventionNames': ['Drug: insulin degludec/insulin aspart 55', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin aspart + insulin degludec - high concentration', 'interventionNames': ['Drug: insulin degludec', 'Drug: insulin aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BIAsp 30 + placebo', 'interventionNames': ['Drug: biphasic insulin aspart 30', 'Drug: placebo']}], 'interventions': [{'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin).', 'armGroupLabels': ['Insulin aspart + insulin degludec', 'Insulin aspart + insulin degludec - high concentration', 'Insulin aspart + insulin degludec - high concentration 1', 'Insulin aspart + insulin degludec - low concentration 1']}, {'name': 'insulin degludec/insulin aspart 30', 'type': 'DRUG', 'description': 'A single dose administered subcutaneously (s.c., under the skin).', 'armGroupLabels': ['IDegAsp 30 + placebo']}, {'name': 'insulin degludec/insulin aspart 40', 'type': 'DRUG', 'description': 'A single dose administered subcutaneously (s.c., under the skin).', 'armGroupLabels': ['IDegAsp 40 + placebo']}, {'name': 'insulin degludec/insulin aspart 45', 'type': 'DRUG', 'description': 'A single dose administered subcutaneously (s.c., under the skin).', 'armGroupLabels': ['IDegAsp 45 + placebo']}, {'name': 'insulin degludec/insulin aspart 55', 'type': 'DRUG', 'description': 'A single dose administered subcutaneously (s.c., under the skin).', 'armGroupLabels': ['IDegAsp 55 + placebo']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'A single dose administered subcutaneously (s.c., under the skin).', 'armGroupLabels': ['Insulin aspart + insulin degludec', 'Insulin aspart + insulin degludec - high concentration', 'Insulin aspart + insulin degludec - high concentration 1', 'Insulin aspart + insulin degludec - low concentration 1']}, {'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'description': 'A single dose administered subcutaneously (s.c., under the skin).', 'armGroupLabels': ['BIAsp 30 + placebo']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'A single dose administered subcutaneously (s.c., under the skin).', 'armGroupLabels': ['BIAsp 30 + placebo', 'IDegAsp 30 + placebo', 'IDegAsp 40 + placebo', 'IDegAsp 45 + placebo', 'IDegAsp 55 + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], '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'}}}}