Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT02529293
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2015-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2015-08-18', 'studyFirstSubmitQcDate': '2015-08-19', 'lastUpdatePostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCLisp (0-inf)', 'timeFrame': '8 hours', 'description': 'Area under the insulin lispro serum concentration - time curve from t=0 to infinity'}, {'measure': 'Cmax Lisp', 'timeFrame': '8 hours', 'description': 'Maximum observed insulin lispro serum concentration'}], 'secondaryOutcomes': [{'measure': 'tmax Lisp', 'timeFrame': '8 hours', 'description': 'Time to maximum observed serum insulin lispro concentration'}, {'measure': 'AUCGIR(0-8h)', 'timeFrame': '8 hours', 'description': 'Area under the glucose infusion rate-time curve from t=0 to 8 hours'}, {'measure': 'GIRmax', 'timeFrame': '8 hours', 'description': 'Maximum glucose infusion rate'}, {'measure': 'tGIRmax', 'timeFrame': '8 hours', 'description': 'Time to maximum glucose infusion rate'}, {'measure': 'Number of Adverse events', 'timeFrame': 'Up to 9 weeks', 'description': 'Number of adverse events'}, {'measure': 'Local tolerability', 'timeFrame': 'Up to 9 weeks', 'description': 'Record of injection site reaction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.\n\nEach subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.\n* Age ≥ 18 and ≤ 64 years, both inclusive.\n* Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.\n* Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).\n* Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).\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.'}, 'identificationModule': {'nctId': 'NCT02529293', 'briefTitle': 'A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adocia'}, 'officialTitle': 'A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female', 'orgStudyIdInfo': {'id': 'BC3-CT012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BioChaperone Lispro U-100', 'description': 'injection of 2 doses of 0.2 U/kg on separate visits', 'interventionNames': ['Drug: BioChaperone Lispro U-100']}, {'type': 'EXPERIMENTAL', 'label': 'BioChaperone Lispro U-200', 'description': 'injection of 2 doses of 0.2 U/kg on separate visits', 'interventionNames': ['Drug: BioChaperone Lispro U-200']}], 'interventions': [{'name': 'BioChaperone Lispro U-100', 'type': 'DRUG', 'description': 'Injection of BioChaperone Lispro U-100', 'armGroupLabels': ['BioChaperone Lispro U-100']}, {'name': 'BioChaperone Lispro U-200', 'type': 'DRUG', 'description': 'Injection of BioChaperone Lispro U-200', 'armGroupLabels': ['BioChaperone Lispro U-200']}]}, '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 Institut Für Stoffwechselfforschung GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adocia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}