Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:29 PM
Study NCT ID:
NCT07305805
Status:
RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-29', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state', 'timeFrame': 'Visit 2 and 3: Day 2 and 3', 'description': 'Measured in milligrams per kilogram (mg/kg).'}], 'secondaryOutcomes': [{'measure': 'GIRmax,SS: Maximum glucose infusion rate at steady state', 'timeFrame': 'Visit 2 and 3: Day 2 and 3', 'description': 'Measured in milligrams per kilogram\\*minute (mg/\\[kg\\*min\\]).'}, {'measure': 'Time to maximum glucose infusion rate (tGIRmax),SS: Time to maximum glucose infusion rate at steady state', 'timeFrame': 'Visit 2 and 3: Day 2 and 3', 'description': 'Measured in hours.'}, {'measure': 'AUC,I1063,SS: Area under the serum NNC0363-1063 concentration time curve at steady state', 'timeFrame': 'Visit 2 and 3: Day 2 and 3', 'description': 'Measured in hours\\*picomoles per litre (h\\*pmol/L).'}, {'measure': 'Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration at steady state', 'timeFrame': 'Visit 2 and 3: Day 2 and 3', 'description': 'Measured in picomoles per litre (pmol/L).'}, {'measure': 'tmax,I1063,SS: Time to maximum observed serum NNC0363-1063 concentration at steady state', 'timeFrame': 'Visit 2 and 3: Day 2 and 3', 'description': 'Measured in hours.'}, {'measure': 'Number of adverse events', 'timeFrame': 'Visit 2 and 3: Day 2 and 3', 'description': 'Measured as number of events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to find out how the novel insulin NNC0363-1063 and a non-glucose carbohydrate used in food and beverage might interact in participants with type 1 diabetes and if co-administration of these substances is safe and tolerable. All participants will get a fixed dose of NNC0363-1063 and an oral administration of different amounts of the non-glucose carbohydrate in a random order during 4 interaction tests. The participants will be in this clinical study for about 5 to 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participant (sex at birth) of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e., documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 month without an alternative medical cause) prior to the day of screening.\n* Age 18-64 years (both inclusive) at the time of signing informed consent.\n* Body mass index between 18.5-29.9 Kilogram Per Square Meter (kg/m\\^2) (both inclusive) at the day of screening.\n* Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year prior to the day of screening.\n* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion ≥ 90 days prior to the day of screening.\n* Glycated haemoglobin (HbA1c) less than or equal to (≤ ) 9.0 percentage (%) at the day of screening.\n\nExclusion Criteria:\n\n* Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.\n* Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT07305805', 'briefTitle': 'A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multiple Dose Study Investigating Pharmacodynamics and Pharmacokinetics of Subcutaneous NNC0363-1063 in Participants With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN1644-8194'}, 'secondaryIdInfos': [{'id': 'U1111-1317-2815', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2025-521593-33', 'type': 'OTHER', 'domain': 'European Medical Agency (EMA)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.', 'interventionNames': ['Drug: NNC0363-1063']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.', 'interventionNames': ['Drug: NNC0363-1063']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.', 'interventionNames': ['Drug: NNC0363-1063']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.', 'interventionNames': ['Drug: NNC0363-1063']}], 'interventions': [{'name': 'NNC0363-1063', 'type': 'DRUG', 'description': 'NNC0363-1063 will be administered subcutaneously.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'centralContacts': [{'name': 'Novo Nordisk', 'role': 'CONTACT', 'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178'}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'https://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}