Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-09 @ 12:44 AM
Study NCT ID:
NCT01620333
Status:
COMPLETED
Last Update Posted:
2017-01-05
First Post:
2012-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2000-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-04', 'studyFirstSubmitDate': '2012-06-13', 'studyFirstSubmitQcDate': '2012-06-13', 'lastUpdatePostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70)'}], 'secondaryOutcomes': [{'measure': 'Cmax, maximum insulin aspart concentration'}, {'measure': 'tmax, time to maximum insulin aspart concentration'}, {'measure': 't½, terminal elimination half life'}, {'measure': 'Mean residence time (MRT)'}, {'measure': 'Area under the curve from time 0 to infinity (0-∞)'}, {'measure': 'Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50)'}, {'measure': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Healthy']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Irie S, Furuie H, Matsuguma K, Matsumura Y. Pharmacokinetics and pharmacodynamics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy Japanese subjects. Diabetologia 2006; 49 (Suppl 1): 612'}, {'type': 'RESULT', 'citation': 'Irie S, Matsumura Y, Furuie H, Matsuguma K. Comparison of the pharmacokinetic and pharmacodynamic properties of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy Japanese. Diabetic Medicine 2006; 23 (Suppl 4): 331 (P915)'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70 (NN-X14Mix70) in Japanese healthy volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Japanese\n* Body Mass Index (BMI) of 19-27 kg/m\\^2 (both inclusive)\n* Fasting blood glucose between 3.8-6 mmol/L (68.4-108.0 mg/dL) (both inclusive\n* Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator\n\nExclusion Criteria:\n\n* Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator or Sub-Investigator(s)\n* Any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator\n* Any inter-current illness that may affect blood glucose, as judged by the Investigator or Sub-Investigator\n* Hepatitis B or C, or HIV (human immunodeficiency virus)\n* Use of prescription drugs within 2 weeks preceding the screening\n* Use of non-prescription drugs, except routine vitamins or drugs that may not\n* Blood donation of more than 1150 mL within the last 12 months\n* Subjects with a first degree relative with diabetes mellitus\n* History of or presence of diabetes\n* History of or presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder\n* Previous history of serious allergy or anaphylactic reaction\n* Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse\n* Subjects who smoke more than 5 cigarettes per day'}, 'identificationModule': {'nctId': 'NCT01620333', 'briefTitle': 'Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Characterizing the Pharmacokinetics and Pharmacodynamics of NN-X14Mix50 and NN-X14Mix70 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'BIASP-1164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment period 1', 'interventionNames': ['Drug: biphasic insulin aspart 50', 'Drug: biphasic insulin aspart 70']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment period 2', 'interventionNames': ['Drug: biphasic insulin aspart 50', 'Drug: biphasic insulin aspart 70']}], 'interventions': [{'name': 'biphasic insulin aspart 50', 'type': 'DRUG', 'description': 'A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days', 'armGroupLabels': ['Treatment period 1', 'Treatment period 2']}, {'name': 'biphasic insulin aspart 70', 'type': 'DRUG', 'description': 'A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days', 'armGroupLabels': ['Treatment period 1', 'Treatment period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000005', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], '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'}}}}