Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-04 @ 6:16 PM
Study NCT ID:
NCT02536859
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2015-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus
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': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-30', 'studyFirstSubmitDate': '2015-08-28', 'studyFirstSubmitQcDate': '2015-08-28', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the glucose infusion rate curve', 'timeFrame': 'During one dosing interval (0-24h) at steady-state. At day 6, 9 and 12'}], 'secondaryOutcomes': [{'measure': 'Area under the glucose infusion rate curve', 'timeFrame': 'During one dosing interval at steady state.At day 6, 9 and 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '28295934', 'type': 'RESULT', 'citation': 'Heise T, Norskov M, Nosek L, Kaplan K, Famulla S, Haahr HL. Insulin degludec: Lower day-to-day and within-day variability in pharmacodynamic response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab. 2017 Jul;19(7):1032-1039. doi: 10.1111/dom.12938. Epub 2017 Apr 23.'}, {'pmid': '28946756', 'type': 'RESULT', 'citation': 'Heise T, Kaplan K, Haahr HL. Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Between Insulin Degludec and Insulin Glargine (100 U/mL and 300 U/mL): A Comparison Across Studies. J Diabetes Sci Technol. 2018 Mar;12(2):356-363. doi: 10.1177/1932296817731422. Epub 2017 Sep 26.'}], '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 pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at steady-state conditions in subjects with type 1 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent\n* Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening\n* Body mass index 18.5-29.0 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)who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period'}, 'identificationModule': {'nctId': 'NCT02536859', 'briefTitle': 'Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Single-centre, Double-blind, Two-period Cross-over, Multiple Dose Trial Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'NN1250-4227'}, 'secondaryIdInfos': [{'id': '2014-005602-37', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1165-3940', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDeg', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IGlar U300', 'interventionNames': ['Drug: insulin glargine']}], 'interventions': [{'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.', 'armGroupLabels': ['IDeg']}, {'name': 'insulin glargine', 'type': 'DRUG', 'description': 'Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.', 'armGroupLabels': ['IGlar U300']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', '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'}}}}