Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-02-20 @ 12:43 PM
Study NCT ID:
NCT02739906
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM
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'}, {'id': 'D007328', 'term': 'Insulin'}], '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'}, {'id': 'D011384', 'term': 'Proinsulin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-17', 'studyFirstSubmitDate': '2016-04-12', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BG1h', 'timeFrame': '1 hour', 'description': 'Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal'}], 'secondaryOutcomes': [{'measure': 'ΔBG1h', 'timeFrame': '1 hour', 'description': 'Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal'}, {'measure': 'AUCBG,0-1h', 'timeFrame': '1 hour', 'description': 'Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal'}, {'measure': 'ΔAUCBG,0-1h', 'timeFrame': '1 hour', 'description': 'Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal'}, {'measure': 'AUCIns,0-1h', 'timeFrame': '1 hour', 'description': 'Area under the serum insulin concentration-time curve from 0-1 hour'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to 11 weeks', 'description': 'Number of Adverse Events'}, {'measure': 'Local tolerability (Number of injection site reactions)', 'timeFrame': 'Up to 11 weeks', 'description': 'Number of injection site reactions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.\n\nEach subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.\n\nFollowing trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.\n\nThe total trial duration for an individual subject will be up to 11 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject aged 18-64 years (both inclusive).\n* Type 1 diabetes mellitus (as diagnosed clinically) \\>= 12 months.\n* Treated with multiple daily insulin injections or CSII \\>= 12 months.\n* Current total daily insulin treatment \\< 1.2 (I)U/kg/day.\n* Current total daily bolus insulin treatment \\< 0.7 (I)U/kg/day.\n* BMI 18.5-28.0 kg/m\\^2 (both inclusive).\n* HbA1c \\<= 9.0 % by local laboratory analysis\n* Fasting C-peptide \\<= 0.30 nmol/L.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to IMPs or related products.\n* Type 2 diabetes mellitus.\n* Previous participation in this trial. Participation is defined as randomised.\n* Participation in any clinical trial within 3 months prior to this trial.\n* Clinically significant abnormal haematology, coagulation, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.\n* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), 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* Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.\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': 'NCT02739906', 'briefTitle': 'A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adocia'}, 'officialTitle': 'A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)', 'orgStudyIdInfo': {'id': 'BC3-CT021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HinsBet®', 'interventionNames': ['Drug: BioChaperone Human Insulin (HinsBet®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog®', 'interventionNames': ['Drug: Insulin Lispro (Humalog®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Huminsulin® Normal', 'interventionNames': ['Drug: Regular human insulin (Huminsulin® Normal)']}], 'interventions': [{'name': 'BioChaperone Human Insulin (HinsBet®)', 'type': 'DRUG', 'description': 'BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake', 'armGroupLabels': ['HinsBet®']}, {'name': 'Insulin Lispro (Humalog®)', 'type': 'DRUG', 'description': 'Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake', 'armGroupLabels': ['Humalog®']}, {'name': 'Regular human insulin (Huminsulin® Normal)', 'type': 'DRUG', 'description': 'Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake', 'armGroupLabels': ['Huminsulin® Normal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Profil Mainz GmbH & Co.KG', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Oliver Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adocia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}