Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-03 @ 6:47 PM
Study NCT ID:
NCT02660502
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2016-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061268', 'term': 'Insulin Lispro'}], '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-27', 'studyFirstSubmitDate': '2016-01-18', 'studyFirstSubmitQcDate': '2016-01-20', 'lastUpdatePostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCLispro(0-30min)', 'timeFrame': 'Up to 30 minutes', 'description': 'Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes'}], 'secondaryOutcomes': [{'measure': 'AUCGIR(0-last)', 'timeFrame': 'Up to 8 hours', 'description': 'Area under the glucose infusion rate time curve from 0 hours until the end of clamp'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to 10 weeks', 'description': 'Number of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.\n\nEach subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits.\n\nThe total trial maximum duration for a subject will be up to 10 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator.\n* BMI between 18.5 and 25.0 kg∙m-2, both inclusive.\n* Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL).\n* Signed and dated informed consent obtained before any trial-related activities.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to trial product(s) or related products.\n* Receipt of any investigational medicinal product within 3 months before randomisation in this trial.\n* Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.\n* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.'}, 'identificationModule': {'nctId': 'NCT02660502', 'briefTitle': 'An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adocia'}, 'officialTitle': 'A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects', 'orgStudyIdInfo': {'id': 'BC3-CT017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BioChaperone insulin lispro 0.1 U/kg', 'interventionNames': ['Drug: Biochaperone insulin lispro 0.1 U/kg']}, {'type': 'EXPERIMENTAL', 'label': 'BioChaperone insulin lispro 0.2 U/kg', 'interventionNames': ['Drug: Biochaperone insulin lispro 0.2 U/kg']}, {'type': 'EXPERIMENTAL', 'label': 'BioChaperone insulin lispro 0.4 U/kg', 'interventionNames': ['Drug: Biochaperone insulin lispro 0.4 U/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog®', 'interventionNames': ['Drug: Humalog®']}], 'interventions': [{'name': 'Biochaperone insulin lispro 0.1 U/kg', 'type': 'DRUG', 'description': 'Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg', 'armGroupLabels': ['BioChaperone insulin lispro 0.1 U/kg']}, {'name': 'Biochaperone insulin lispro 0.2 U/kg', 'type': 'DRUG', 'description': 'Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg', 'armGroupLabels': ['BioChaperone insulin lispro 0.2 U/kg']}, {'name': 'Biochaperone insulin lispro 0.4 U/kg', 'type': 'DRUG', 'description': 'Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg', 'armGroupLabels': ['BioChaperone insulin lispro 0.4 U/kg']}, {'name': 'Humalog®', 'type': 'DRUG', 'description': 'Injection of a single dose of Humalog® at the dose of 0.2 U/kg', 'armGroupLabels': ['Humalog®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Grit Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adocia', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}