Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-25 @ 2:34 PM
Study NCT ID:
NCT06647550
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-10-10', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change in body weight at weeks 6 and 12 from baseline', 'timeFrame': 'at weeks 6 and 12 from baseline', 'description': 'change in body weight at weeks 6 and 12 from baseline'}, {'measure': 'change in GA/HbA1c at weeks 6 and 12 from baseline', 'timeFrame': 'at weeks 6 and 12 from baseline', 'description': 'change in GA/HbA1c at weeks 6 and 12 from baseline'}], 'primaryOutcomes': [{'measure': 'change in HbA1c at weeks 12 from baseline', 'timeFrame': 'at weeks 12 from baseline', 'description': 'change in HbA1c at weeks 12 from baseline'}], 'secondaryOutcomes': [{'measure': 'change in HbA1c at weeks 6 from baseline', 'timeFrame': 'at weeks 6 from baseline', 'description': 'change in HbA1c at weeks 6 from baseline'}, {'measure': 'percentage of subjects with HbA1c level below 7.0% at weeks 12', 'timeFrame': 'at weeks 12', 'description': 'percentage of subjects with HbA1c level below 7.0% at weeks 12'}, {'measure': 'percentage of subjects with HbA1c level below 6.5% at weeks 12', 'timeFrame': 'at weeks 12', 'description': 'percentage of subjects with HbA1c level below 6.5% at weeks 12'}, {'measure': 'change in Glycoalbumin at weeks 6 and 12 from baseline', 'timeFrame': 'at weeks 6 and 12 from baseline', 'description': 'change in Glycoalbumin at weeks 6 and 12 from baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': 'A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise', 'detailedDescription': 'This trial is a phase 2 study to evaluate the efficacy and safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise.\n\nThis is multi-center, double-blind, placebo-controlled, parallel-group, dose-finding phase 2 study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 8 weeks prior to screening.\n\nExclusion Criteria:\n\n* Type 1 diabetes or another immune-mediated diabetes syndrome\n* BMI: \\> 40 kg/m2\n* C-peptide: \\< 0.5ng/mL'}, 'identificationModule': {'nctId': 'NCT06647550', 'acronym': 'HDNO-1605', 'briefTitle': 'To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hyundai Pharm'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise', 'orgStudyIdInfo': {'id': 'HT-006-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HD-6277 100mg tab', 'description': 'Oral tablet', 'interventionNames': ['Drug: HD-6277 100mg']}, {'type': 'EXPERIMENTAL', 'label': 'HD-6277 50mg tab', 'description': 'Oral tablet', 'interventionNames': ['Drug: HD-6277 50mg']}, {'type': 'EXPERIMENTAL', 'label': 'HD-6277 25mg tab', 'description': 'Oral tablet', 'interventionNames': ['Drug: HD-6277 25mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HD-6277 100mg', 'type': 'DRUG', 'description': 'PO, QD', 'armGroupLabels': ['HD-6277 100mg tab']}, {'name': 'HD-6277 50mg', 'type': 'DRUG', 'description': 'PO, QD', 'armGroupLabels': ['HD-6277 50mg tab']}, {'name': 'HD-6277 25mg', 'type': 'DRUG', 'description': 'PO, QD', 'armGroupLabels': ['HD-6277 25mg tab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'PO, QD', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sin-Gon Kim, PhD', 'role': 'CONTACT', 'email': 'k50367@korea.ac.kr'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sin Gon Kim Korea University Anam Hospital, PhD', 'role': 'CONTACT', 'email': 'k50367@korea.ac.kr', 'phone': '+82 1577-0083'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyundai Pharm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}