Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-22 @ 11:11 AM
Study NCT ID:
NCT02146651
Status:
COMPLETED
Last Update Posted:
2014-12-10
First Post:
2014-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-09', 'studyFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2014-05-21', 'lastUpdatePostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucodynamic endpoint: Area Under the Curve GIR(0-last)', 'timeFrame': '12 hours', 'description': 'Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp'}, {'measure': 'Glucodynamic endpoint: GIRMax', 'timeFrame': '12 hours', 'description': 'Maximum Glucose Infusion Rate'}, {'measure': 'Pharmacokinetic endpoint: AUC Lisp(0-last)', 'timeFrame': '12 hours', 'description': 'Area under the insulin lispro serum concentration - time curve over the clamp procedure.'}, {'measure': 'Pharmacokinetic endpoint: Cmax(Lisp)', 'timeFrame': '12 hours', 'description': 'Maximum observed serum insulin lispro concentration'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Tmax(lisp)', 'timeFrame': '12 hours', 'description': 'Time to maximum observed serum insulin lispro concentration'}, {'measure': 'Glucodynamic: TGIRmax', 'timeFrame': '12 hours', 'description': 'Time to maximum Glucose Infusion Rate'}, {'measure': 'Tonset of action', 'timeFrame': '12 hours', 'description': 'Time from t=0 until blood glucose concentration has decreased by 5mg.dL (0.3mmol.L) from baseline.'}, {'measure': 'Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 1']}, 'descriptionModule': {'briefSummary': 'The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.\n\nThe aim of the trial is to investigate the dose-response and the dose-exposure relationships of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.\n\nThis is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus.\n\nEach subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of Humalog® (0.2 U/Kg) on 4 separate dosing visits.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 1 diabetes mellitus for at least 12 months\n* Treated with multiple daily insulin injections of insulin pump for at least 12 months\n* Body Mass Index (BMI): 18.5-28.0 Kg.m²\n\nExclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Receipt of any investigational product within 3 months prior first dosing\n* Clinically significant abnormalities as judged by the investigator\n* Any systemic treatment with drugs known to interfere with glucose metabolism\n* History of alcoholism or drug/chemical abuse as per investigator's judgement\n* Use of tobacco or nicotine-contained product within 1 year prior to screening\n* Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening"}, 'identificationModule': {'nctId': 'NCT02146651', 'briefTitle': 'A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adocia'}, 'officialTitle': 'A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'BC3-CT008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BioChaperone insulin lispro 0.2U/Kg', 'description': 'BioChaperone insulin lispro 0.2U/Kg', 'interventionNames': ['Drug: BioChaperone insulin lispro 0.2U/Kg', 'Drug: BioChaperone insulin lispro 0.1U/Kg', 'Drug: BioChaperone insulin lispro 0.4U/Kg', 'Drug: Humalog®']}, {'type': 'EXPERIMENTAL', 'label': 'BioChaperone insulin lispro 0.1U/Kg', 'description': 'BioChaperone insulin lispro 0.1U/Kg', 'interventionNames': ['Drug: BioChaperone insulin lispro 0.2U/Kg', 'Drug: BioChaperone insulin lispro 0.1U/Kg', 'Drug: BioChaperone insulin lispro 0.4U/Kg', 'Drug: Humalog®']}, {'type': 'EXPERIMENTAL', 'label': 'BioChaperone insulin lispro 0.4U/Kg', 'description': 'BioChaperone insulin lispro 0.4U/Kg', 'interventionNames': ['Drug: BioChaperone insulin lispro 0.2U/Kg', 'Drug: BioChaperone insulin lispro 0.1U/Kg', 'Drug: BioChaperone insulin lispro 0.4U/Kg', 'Drug: Humalog®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog® 0.2U/Kg', 'description': 'Humalog® 0.2U/Kg', 'interventionNames': ['Drug: BioChaperone insulin lispro 0.2U/Kg', 'Drug: BioChaperone insulin lispro 0.1U/Kg', 'Drug: BioChaperone insulin lispro 0.4U/Kg', 'Drug: Humalog®']}], 'interventions': [{'name': 'BioChaperone insulin lispro 0.2U/Kg', 'type': 'DRUG', 'description': 'Single dose of 0.2U/Kg body weight injected subcutaneously', 'armGroupLabels': ['BioChaperone insulin lispro 0.1U/Kg', 'BioChaperone insulin lispro 0.2U/Kg', 'BioChaperone insulin lispro 0.4U/Kg', 'Humalog® 0.2U/Kg']}, {'name': 'BioChaperone insulin lispro 0.1U/Kg', 'type': 'DRUG', 'description': 'Single dose of 0.1U/Kg body weight injected subcutaneously', 'armGroupLabels': ['BioChaperone insulin lispro 0.1U/Kg', 'BioChaperone insulin lispro 0.2U/Kg', 'BioChaperone insulin lispro 0.4U/Kg', 'Humalog® 0.2U/Kg']}, {'name': 'BioChaperone insulin lispro 0.4U/Kg', 'type': 'DRUG', 'description': 'Single dose of 0.4U/Kg body weight injected subcutaneously', 'armGroupLabels': ['BioChaperone insulin lispro 0.1U/Kg', 'BioChaperone insulin lispro 0.2U/Kg', 'BioChaperone insulin lispro 0.4U/Kg', 'Humalog® 0.2U/Kg']}, {'name': 'Humalog®', 'type': 'DRUG', 'description': 'Single dose of 0.2U/Kg body weight injected subcutaneously', 'armGroupLabels': ['BioChaperone insulin lispro 0.1U/Kg', 'BioChaperone insulin lispro 0.2U/Kg', 'BioChaperone insulin lispro 0.4U/Kg', 'Humalog® 0.2U/Kg']}]}, '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'}}}}