Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-29 @ 4:59 AM
Study NCT ID:
NCT01269606
Status:
COMPLETED
Last Update Posted:
2014-06-16
First Post:
2011-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Insulin Aspart With Fast-acting Insulin Human 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': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D007328', 'term': 'Insulin'}], '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': 'D011384', 'term': 'Proinsulin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-13', 'studyFirstSubmitDate': '2011-01-03', 'studyFirstSubmitQcDate': '2011-01-03', 'lastUpdatePostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clearance at steady state (CLss) for IV treatment group', 'timeFrame': 'from 180 min to 240 min'}, {'measure': 'Area under the curve (AUC) for IM treatment group', 'timeFrame': 'from 0 to 480 min after intramuscular injection'}], 'secondaryOutcomes': [{'measure': 'Area under the curve (AUC) for IM treatment group', 'timeFrame': 'from 0 minutes to infinite time after intramuscular injection'}, {'measure': 'Steady state concentration (Css) for IV treatment group', 'timeFrame': 'from 180 min to 240 min'}, {'measure': 'Hypoglycaemic episodes', 'timeFrame': 'from screening (visit 1) to follow-up visit (2-21 days after last trial product administration)'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'from first trial related activity to follow-up visit (2-21 days after last trial product administration)'}]}, '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 Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months\n* Treated with multiple daily insulin injections for at least 12 months\n* Current daily basal insulin requirement above or equal to 0.3 U/kg/day\n* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0%\n* Body Mass Index (BMI) 18.0-28.0 kg/m\\^2\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 trial start (screening)\n* Surgery or trauma with significant blood loss (more than 500 mL) within 3 months prior to trial start (screening)\n* Subject who smokes more than 10 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': 'NCT01269606', 'briefTitle': 'Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Comparing the Pharmacokinetic Properties of Insulin Aspart With Fast-acting Insulin Human Following Intravenous Infusion or Intramuscular Injection in Japanese Subjects With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'ANA-3877'}, 'secondaryIdInfos': [{'id': 'U1111-1117-1353', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-111383', 'type': 'OTHER', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 1 - IM treatment group', 'interventionNames': ['Drug: insulin aspart']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 2 - IM treatment group', 'interventionNames': ['Drug: insulin human']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 1 - IV treatment group', 'interventionNames': ['Drug: insulin aspart']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 2 - IV treatment group', 'interventionNames': ['Drug: insulin human']}], 'interventions': [{'name': 'insulin aspart', 'type': 'DRUG', 'description': 'At the first treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. At the second treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.', 'armGroupLabels': ['Treatment sequence 1 - IM treatment group']}, {'name': 'insulin human', 'type': 'DRUG', 'description': 'At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.', 'armGroupLabels': ['Treatment sequence 2 - IM treatment group']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'At the first treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. At the second treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.', 'armGroupLabels': ['Treatment sequence 1 - IV treatment group']}, {'name': 'insulin human', 'type': 'DRUG', 'description': 'At the first treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. At the second treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.', 'armGroupLabels': ['Treatment sequence 2 - IV treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '812-0025', 'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], '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'}}}}