Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT06976658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucokinase Activator in Monogenic Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629807', 'term': 'Dorzagliatin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Investigators, outcome assessors'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-03-22', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment-emergent adverse events', 'timeFrame': '8 weeks', 'description': 'Proportion of participants with adverse events in each treatment period'}, {'measure': 'Hypoglycemia', 'timeFrame': '8 weeks', 'description': 'Incidence of hypoglycemic events'}, {'measure': 'Blood pressure', 'timeFrame': '8 weeks', 'description': 'Blood pressure at end of each treatment period'}, {'measure': 'Body weight', 'timeFrame': '8 weeks', 'description': 'Body weight at end of each treatment period'}, {'measure': 'Renal and liver function tests', 'timeFrame': '8 weeks', 'description': 'Safety labs at end of treatment'}, {'measure': 'Lipid profile', 'timeFrame': '8 weeks', 'description': 'Safety labs at end of treatment'}], 'primaryOutcomes': [{'measure': 'Fasting plasma glucose', 'timeFrame': '8 weeks', 'description': 'Difference in fasting plasma glucose (FPG) between treatment periods'}], 'secondaryOutcomes': [{'measure': '• HbA1c', 'timeFrame': '8 weeks', 'description': 'Difference between HbA1c at end of treatment periods'}, {'measure': 'CGM metrics time in range', 'timeFrame': '8 weeks', 'description': 'Time in range defined by CGM at end of treatment periods'}, {'measure': 'CGM metric coefficient of variation', 'timeFrame': '8 weeks', 'description': 'Difference in % CV at end of treatment periods'}, {'measure': 'Glucose area under the curve during OGTT', 'timeFrame': '8 weeks', 'description': 'Difference between AUC glucose at end of treament periods'}, {'measure': 'Insulin area under the curve during OGTT', 'timeFrame': '8 weeks', 'description': 'Difference between AUC insulin at end of treament periods'}, {'measure': 'GLP1 area under the curve during OGTT', 'timeFrame': '8 weeks', 'description': 'Difference between AUC GLP-1 at end of treament periods'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GCK-MODY', 'glucokinase activator'], 'conditions': ['Diabetes Mellitus', 'Monogenic Diabetes']}, 'descriptionModule': {'briefSummary': 'Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial', 'detailedDescription': 'Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 and \\<75 years\n2. body mass index (BMI) \\>18 and \\<30 kg/m2\n3. fasting plasma glucose \\>5.6 mmol/L at screening\n4. Participants with GCK-MODY had and are heterozygous carriers of a pathogenic or likely pathogenic GCK mutation at screening based on guidelines published by the American College of Medical Genetics and Genomics (ACMG), Association for Clinical Genomic Science (ACGS) and the ClinGen Monogenic Diabetes Expert Panel (MDEP) .\n\nExclusion Criteria:\n\n1. Body weight \\<45kg at screening\n2. Current or planning pregnancy or lactating\n3. troke or cardiovascular disease within 6 months of recruitment\n4. severe renal dysfunction (estimated glomerular filtration rate \\<30mL/min/1.73m2 or renal replacement therapy)\n5. severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase \\> 3 times upper limit of normal)\n6. history of drug abuse or excessive alcohol intake\n7. severe hypoglycemia within 6 months prior to screening\n8. anaemia with Hb \\<10 g/dL at screening\n9. excessive blood loss \\>300mL within 1 month of screening\n10. use of strong or moderate CYP3A4 inhibitors or inducers\n11. use of sulfonylureas, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists, sodium glucose transporter 2 inhibitors, insulin, thiazolidinediones, acarbose in the 6 weeks prior to randomisation\n12. use of long-term high-dose corticosteroids at randomisation\n13. serious concurrent infections at time of screening'}, 'identificationModule': {'nctId': 'NCT06976658', 'acronym': 'RESENSE', 'briefTitle': 'Glucokinase Activator in Monogenic Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Evaluating a Novel, Allosteric Glucokinase Activator in Monogenic Diabetes Secondary to Inactivating Glucokinase Mutations: a Randomised, Cross-over Trial', 'orgStudyIdInfo': {'id': 'RESENSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'active drug or placebo in a cross over randomised sequence', 'interventionNames': ['Drug: Dorzagliatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo in a cross over randomised sequence', 'interventionNames': ['Drug: matched placebo']}], 'interventions': [{'name': 'Dorzagliatin', 'type': 'DRUG', 'description': 'Dorzagliatin 50mg bd', 'armGroupLabels': ['Intervention']}, {'name': 'matched placebo', 'type': 'DRUG', 'description': 'matched placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Shun Ling KONG, MSc', 'role': 'CONTACT', 'email': 'slkong@cuhk.edu.hk', 'phone': '+852 35052648'}], 'facility': '3M, Diabetes and Endocrine Research Center', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Elaine Chow, MD', 'role': 'CONTACT', 'email': 'e.chow@cuhk.edu.hk', 'phone': '+852 35051641'}, {'name': 'Shun Ling KONG, MSc', 'role': 'CONTACT', 'email': 'slkong@cuhk.edu.hk', 'phone': '+85235051648'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Elaine Chow', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}