Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 6:03 PM
Study NCT ID:
NCT07076056
Status:
COMPLETED
Last Update Posted:
2025-07-21
First Post:
2025-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-13', 'studyFirstSubmitDate': '2025-07-13', 'studyFirstSubmitQcDate': '2025-07-13', 'lastUpdatePostDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% change of HbA1c', 'timeFrame': '24 weeks', 'description': '% change of HbA1c in week 24 from baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are diagnosed with Type2 Diabetes\n* 19 ≤ Age ≤ 85\n* 7.0% ≤ HbA1c ≤ 10.5%\n\nExclusion Criteria:\n\n* Patients with a history of acute pancreatitis\n* Patients with a history of pre-diabetic coma\n* Patients with a history of diagnosis of malignant tumors within 5 years prior to visit 1'}, 'identificationModule': {'nctId': 'NCT07076056', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy', 'orgStudyIdInfo': {'id': 'DW1026-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DW1026C1 & DW1026C2 placebo & DW1026S placebo', 'interventionNames': ['Drug: DW1026C1']}, {'type': 'EXPERIMENTAL', 'label': 'DW1026C1 placebo & DW1026C2 & DW1026S placebo', 'interventionNames': ['Drug: DW1026C2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'DW1026C1 placebo & DW1026C2 placebo & DW1026S', 'interventionNames': ['Drug: DW1026S']}], 'interventions': [{'name': 'DW1026C1', 'type': 'DRUG', 'description': 'Sitagliptin 100mg+Empagliflozin 10mg', 'armGroupLabels': ['DW1026C1 & DW1026C2 placebo & DW1026S placebo']}, {'name': 'DW1026C2', 'type': 'DRUG', 'description': 'Sitagliptin 100mg+Empagliflozin 25mg', 'armGroupLabels': ['DW1026C1 placebo & DW1026C2 & DW1026S placebo']}, {'name': 'DW1026S', 'type': 'DRUG', 'description': 'Sitagliptin 100mg', 'armGroupLabels': ['DW1026C1 placebo & DW1026C2 placebo & DW1026S']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "Yeouido St. Mary's Hospital The Catholic University", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}