Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 7:45 PM
Study NCT ID:
NCT03179332
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}], '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': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCGIR(0-60min)', 'timeFrame': '60 minutes', 'description': 'Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration'}], 'secondaryOutcomes': [{'measure': 'AUCins(0-30min)', 'timeFrame': '30 minutes', 'description': 'Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration'}, {'measure': 'AUCins(0-60min)', 'timeFrame': '60 minutes', 'description': 'Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration'}, {'measure': 'AUCins(0-600min)', 'timeFrame': '600 minutes', 'description': 'Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration'}, {'measure': 'Cmax insulin', 'timeFrame': '10 hours', 'description': 'Maximum observed baseline corrected insulin concentration'}, {'measure': 'Tmax insulin', 'timeFrame': '10 hours', 'description': 'Time from bolus administration to baseline corrected Cmax'}, {'measure': 'TmaxGIR', 'timeFrame': '10 hours', 'description': 'Time from bolus administration to maximum baseline corrected glucose infusion rate'}, {'measure': 'GIRmax', 'timeFrame': '10 hours', 'description': 'Maximum baseline corrected glucose infusion rate'}, {'measure': 'Adverse Events', 'timeFrame': 'up to 8 weeks', 'description': 'Number of Adverse Events in each arm'}, {'measure': 'Clinical safety laboratory', 'timeFrame': 'up to 8 weeks', 'description': 'Haematology, biochemistry and urinalysis: changes and findings from Baseline in clinical safety laboratory parameters during the trial duration, from screening, and at follow-up visit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. In a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 U/kg body weight.\n\nThroughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 Diabetes Mellitus for more than 12 months.\n* BMI between 18.5 and 28.5 kg/m².\n* HbA1C level \\<=9.0%.\n* Insulin treated for at least 12 months with total insulin dose \\<1.2U/kg/day.\n\nExclusion Criteria:\n\n* Type 2 Diabetes Mellitus.\n* History of multiple and/or severe allergies to drugs or foods.\n* Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.\n* More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.\n* Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.\n* Females of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods.'}, 'identificationModule': {'nctId': 'NCT03179332', 'briefTitle': 'A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adocia'}, 'officialTitle': 'A Euglycaemic Clamp Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of a Bolus Dose of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® by an Insulin Pump', 'orgStudyIdInfo': {'id': 'CT032-ADO02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BioChaperone® insulin lispro', 'description': 'Single subcutaneous administration of BioChaperone® insulin lispro', 'interventionNames': ['Drug: BioChaperone® insulin lispro']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fiasp®', 'description': 'Single subcutaneous administration of Fiasp® (insulin aspart)', 'interventionNames': ['Drug: Fiasp®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Novorapid®', 'description': 'Single subcutaneous administration of Novorapid® (insulin aspart)', 'interventionNames': ['Drug: Novorapid®']}], 'interventions': [{'name': 'BioChaperone® insulin lispro', 'type': 'DRUG', 'description': 'Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump', 'armGroupLabels': ['BioChaperone® insulin lispro']}, {'name': 'Fiasp®', 'type': 'DRUG', 'description': 'Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump', 'armGroupLabels': ['Fiasp®']}, {'name': 'Novorapid®', 'type': 'DRUG', 'description': 'Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump', 'armGroupLabels': ['Novorapid®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Oliver Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Institut für Stoffwechselforschung GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adocia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}