Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-03-05 @ 1:04 AM
Study NCT ID:
NCT02344992
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2015-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-31', 'studyFirstSubmitDate': '2015-01-19', 'studyFirstSubmitQcDate': '2015-01-19', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the blood glucose time curve: AUCbg(0-2h)', 'timeFrame': '2 hours', 'description': 'Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)', 'timeFrame': '8 hours'}, {'measure': 'Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax', 'timeFrame': '8 hours'}, {'measure': 'Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)', 'timeFrame': '8 hours'}, {'measure': 'Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)', 'timeFrame': '8 hours'}, {'measure': 'Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters', 'timeFrame': 'Up to 7 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 1']}, 'descriptionModule': {'briefSummary': 'The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.\n\nThis trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.\n\nThis is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 Diabetes Mellitus ≥ 12 months\n* Treated with multiple daily insulin injections or CSII ≥ 12 months\n* BMI 18.5-28.0 kg/m² (both inclusive)\n* HbA1C%≤9%\n\nExclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Receipt of any trial product within 60 days prior to this trial\n* Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease\n* Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator\n* Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.\n* Any systemic treatment with drugs known to interfere with glucose metabolism\n* Use of any tobacco or nicotine-contained product within one year prior to screening'}, 'identificationModule': {'nctId': 'NCT02344992', 'briefTitle': 'Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adocia'}, 'officialTitle': 'Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal', 'orgStudyIdInfo': {'id': 'BC3-CT011'}, 'secondaryIdInfos': [{'id': '2014-005028-92', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biochaperone Insulin Lispro', 'interventionNames': ['Drug: BioChaperone insulin lispro']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog®', 'interventionNames': ['Drug: Humalog®']}], 'interventions': [{'name': 'BioChaperone insulin lispro', 'type': 'DRUG', 'description': 'Single dose of 0.2 U/kg body weight injected subcutaneously', 'armGroupLabels': ['Biochaperone Insulin Lispro']}, {'name': 'Humalog®', 'type': 'DRUG', 'description': 'Single dose of 0.2 U/kg body weight injected subcutaneously', 'armGroupLabels': ['Humalog®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil 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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}