Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-04 @ 2:13 PM
Study NCT ID:
NCT06588504
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2024-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents
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': 'C000710373', 'term': 'dasiglucagon'}, {'id': 'D005934', 'term': 'Glucagon'}], 'ancestors': [{'id': 'D052336', 'term': 'Proglucagon'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-06', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adults cohort: Time to plasma glucose (PG) recovery, where PG recovery is defined as the first increase in PG of greater than or equal to (>=) 20 milligrams per decilitre (mg/dL) (1.1 millimoles per litre [mmol/L]) from baseline', 'timeFrame': 'From 0 to 90 minutes after investigational medicinal product (IMP) injection', 'description': 'Measured in minutes.'}], 'secondaryOutcomes': [{'measure': 'Adolescent cohort: Time to PG recovery, where PG recovery is defined as the first increase in PG of >=20 mg/dL (1.1 mmol/L) from baseline', 'timeFrame': 'From 0 to 90 minutes after IMP injection', 'description': 'Measured in minutes.'}, {'measure': 'PG recovery within 30 minutes after IMP injection (yes/no)', 'timeFrame': 'From 0 to 30 minutes after IMP injection', 'description': 'Measured in count of participant.'}, {'measure': 'PG recovery within 20 minutes after IMP injection (yes/no)', 'timeFrame': 'From 0 to 20 minutes after IMP injection', 'description': 'Measured in count of participant.'}, {'measure': 'PG recovery within 15 minutes after IMP injection (yes/no)', 'timeFrame': 'From 0 to 15 minutes after IMP injection', 'description': 'Measured in count of participant.'}, {'measure': 'PG change from baseline at 15 minutes after IMP injection', 'timeFrame': 'From 0 to 15 minutes after IMP injection', 'description': 'Measured in milligrams per deciliter (mg/dL).'}, {'measure': 'PG change from baseline at 20 minutes after IMP injection', 'timeFrame': 'From 0 to 20 minutes after IMP injection', 'description': 'Measured in mg/dL.'}, {'measure': 'Area under the plasma dasiglucagon concentration time curve after IMP injection', 'timeFrame': 'On Day 1 after injection', 'description': 'Measured in hour\\*picomoles per liter (h\\*pmol/L).'}, {'measure': 'Maximum observed plasma (Cmax) dasiglucagon concentration', 'timeFrame': 'From 0 to 5 hours after IMP injection', 'description': 'Measured in pmol/L.'}, {'measure': 'Number of adverse events (AEs)', 'timeFrame': 'From IMP injection (visit 2 day 1 and visit 3 day 1) until 28 days after IMP injection', 'description': 'Measured in number of events.'}, {'measure': 'Number of hypoglycaemic episodes', 'timeFrame': 'From IMP injection (visit 2 day 1 and visit 3 day 1) until 12 hours after IMP injection', 'description': 'Measured in number of episodes.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'This study will be looking to confirm the effect of dasiglucagon when compared with glucagon for treating very low sugar levels in Asian adults with T1D and the effect of dasiglucagon in Japanese adolescents with T1D. This study wants to demonstrate that dasiglucagon can raise low blood sugar levels just as well as glucagon. Participants will get dasiglucagon and glucagon. In which treatment order participants get study medicines (dasiglucagon and glucagon) is decided by chance. Dasiglucagon is a new medicine, but doctors can prescribe it in the US as it is approved there. Doctors can prescribe glucagon in multiple countries including Japan as an approved medicine. The study will last for about 17 weeks. Participant cannot be in the study if the study doctor thinks that there are risks for participants health. Women cannot take part if pregnant, breast-feeding, plan to get pregnant, during the study period, or not using adequate contraceptive methods. For man: if participant have sex, participant and his partner must use an adequate birth control method during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For Adults: Asian male or female; For Adolescents: Japanese male or female.\n* Age at the time of signing the informed consent:\n\nFor Adults: Age 18-75 years (both inclusive):\n\nFor Adolescents: Age 12-15 years (both inclusive).\n\n* Diagnosed with T1D greater than (\\>)1 year before screening.\n* Glycated haemoglobin (HbA1c) less than (\\<)10.0 percentage (%) (86 millimoles per mole \\[mmol/mol\\]) as assessed by subcontracted laboratory by the site on the day of screening.\n* For adults: BMI between 18.5 and 29.9 kilogram per meter square (kg/m2) (both inclusive).\n\nFor adolescents: Body weight greater than or equal to (≥) 33.4 kilograms (kg).\n\n* Treated with stable insulin treatment (based on the investigator's discretion preferably no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening.\n* For Japanese participants: Japanese passport or equivalent For non-Japanese participants: Asian (non- Japanese passport or equivalent).\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products (glucagon or its derivatives).\n* Exposure to an investigational medicinal product (IMP) within 30 days or 5 times the half-life of the IMP (if known), whichever is longest before screening.\n* Severe hypoglycaemia in the last month prior to screening.\n* Hospitalisation for diabetic ketoacidosis (DKA) in the last month prior to screening.\n* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus).\n* History of epilepsy or seizure disorder.\n* Known presence or history of pheochromocytoma (i.e., adrenal gland tumour) or insulinoma (i.e., insulin-secreting pancreas tumour).\n* Clinically significant abnormal electrocardiogram (ECG) at screening as evaluated by investigator.\n* Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.\n\nAs declared by the participant or in the medical records."}, 'identificationModule': {'nctId': 'NCT06588504', 'briefTitle': 'Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Phase 3, Randomised, Open-label, Cross-over Study to Confirm the Clinical Efficacy and Safety of Dasiglucagon Versus Glucagon for the Treatment of Severe Hypoglycaemia in Asian Adults With Type 1 Diabetes (T1D) Including an Investigation of Dasiglucagon in a Japanese Adolescent Cohort', 'orgStudyIdInfo': {'id': 'NN9515-7675'}, 'secondaryIdInfos': [{'id': 'U1111-1300-1855', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': 'jRCT2071240050', 'type': 'REGISTRY', 'domain': 'Japan Registry for Clinical Trials (jRCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adult Cohort: Dasiglucagon then Glucagon', 'description': 'Participants will receive a single subcutaneous (s.c.) injection of dasiglucagon in first dosing visit then a single intra-mascular (i.m.) injection of glucagon in next dosing visit.', 'interventionNames': ['Drug: Dasiglucagon']}, {'type': 'EXPERIMENTAL', 'label': 'Adult Cohort: Glucagon then Dasiglucagon', 'description': 'Participants will receive a single i.m. injection of glucagon in first dosing visit then a single s.c. injection of dasiglucagon in next dosing visit.', 'interventionNames': ['Drug: Dasiglucagon', 'Drug: Glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'Adolescent Cohort: Dasiglucagon', 'description': 'Participants will receive a single s.c. injection of dasiglucagon.', 'interventionNames': ['Drug: Dasiglucagon']}], 'interventions': [{'name': 'Dasiglucagon', 'type': 'DRUG', 'description': 'Participants will receive s.c. injection of dasiglucagon.', 'armGroupLabels': ['Adolescent Cohort: Dasiglucagon', 'Adult Cohort: Dasiglucagon then Glucagon', 'Adult Cohort: Glucagon then Dasiglucagon']}, {'name': 'Glucagon', 'type': 'DRUG', 'description': 'Participants will receive i.m. injection of glucagon.', 'armGroupLabels': ['Adult Cohort: Glucagon then Dasiglucagon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '812-0025', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Hakata Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], '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'}}}}