Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT05505994
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2022-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729921', 'term': 'Enavogliflozin'}, {'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Part 1: Double-blind Part 2: Open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in HbA1c', 'timeFrame': 'at 24 weeks', 'description': 'Change in HbA1c (%) is assessed with the values measured at the central laboratory'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dapagliflozin', 'Sodium-Glucose Transporter 2 Inhibitors', 'Molecular Mechanisms of Pharmacological Action', 'Hypoglycemic Agents', 'Physiological Effects of Drugs'], 'conditions': ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Glucose Metabolism Disorders', 'Metabolic Disease', 'Endocrine System Diseases']}, 'descriptionModule': {'briefSummary': 'Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.', 'detailedDescription': 'A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects with T2DM aged 18 to 80 years\n2. Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%\n3. Subjects with BMI of 20-45 kg/m2\n4. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study\n\nExclusion Criteria:\n\n1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)\n2. Diabetic ketoacidosis, diabetic coma or precoma within the past year\n3. Urinary tract infections or genital infections within\n4. Uncontrolled hypertension (SBP \\> 180 mmHg or DBP \\> 110 mmHg)\n5. eGFR \\< 60 mL/min/1.73 m2\n6. Severe heart failure (NYHA class III/IV)'}, 'identificationModule': {'nctId': 'NCT05505994', 'briefTitle': 'The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of DWP16001 Add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin', 'orgStudyIdInfo': {'id': 'DW_DWP16001304_CN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'DWP16001 A mg, Dapagliflozin placebo', 'interventionNames': ['Drug: DWP16001', 'Drug: Dapagliflozin Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'DWP16001 A mg placebo, Dapagliflozin', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: DWP16001 Placebo']}], 'interventions': [{'name': 'DWP16001', 'type': 'DRUG', 'otherNames': ['DWP16001 tablet'], 'description': 'DWP16001 A mg tablet', 'armGroupLabels': ['Study group']}, {'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['Dapagliflozin tablet'], 'description': 'Dapagliflozin tablet', 'armGroupLabels': ['Control group']}, {'name': 'DWP16001 Placebo', 'type': 'DRUG', 'otherNames': ['DWP16001 Placebo tablet'], 'description': 'DWP16001 Placebo tablet', 'armGroupLabels': ['Control group']}, {'name': 'Dapagliflozin Placebo', 'type': 'DRUG', 'otherNames': ['Dapagliflozin Placebo tablet'], 'description': 'Dapagliflozin Placebo tablet', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+86', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Linong Ji, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}