Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT04660305
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2020-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AT278 and NovoRapid® in Glucose Clamp Study
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': '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': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the glucose infusion-rate curve of insulin aspart', 'timeFrame': '0 - 8 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of type 1 diabetes for at least 12 months\n2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months\n3. HbA1c concentration ≤8.5% at screening\n4. Weight within the range 75kg - 100kg (both inclusive)\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to Investigational Medicinal Products\n2. Clinically significant concomitant disease or abnormal lab values\n3. Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG'}, 'identificationModule': {'nctId': 'NCT04660305', 'briefTitle': 'AT278 and NovoRapid® in Glucose Clamp Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arecor Limited'}, 'officialTitle': 'Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).', 'orgStudyIdInfo': {'id': 'ARE-278-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AT278', 'description': 'Single subcutaneous injection 0.3U/kg', 'interventionNames': ['Drug: AT278', 'Drug: NovoRapid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NovoRapid', 'description': 'Single subcutaneous injection 0.3U/kg', 'interventionNames': ['Drug: AT278', 'Drug: NovoRapid']}], 'interventions': [{'name': 'AT278', 'type': 'DRUG', 'description': 'Concentrated rapid acting insulin aspart', 'armGroupLabels': ['AT278', 'NovoRapid']}, {'name': 'NovoRapid', 'type': 'DRUG', 'otherNames': ['NovoLog'], 'description': 'Rapid acting insulin aspart', 'armGroupLabels': ['AT278', 'NovoRapid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Clinical Trials Unit, Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arecor Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}