Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT04634500
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2020-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C000729921', 'term': 'Enavogliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-23', 'studyFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2020-11-17', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in HbA1c', 'timeFrame': 'at 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['T2DM (Type 2 Diabetes Mellitus)']}, 'referencesModule': {'references': [{'pmid': '36756676', 'type': 'DERIVED', 'citation': 'Han KA, Kim YH, Kim DM, Lee BW, Chon S, Sohn TS, Jeong IK, Hong EG, Son JW, Nah JJ, Song HR, Cho SI, Cho SA, Yoon KH. Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial. Diabetes Metab J. 2023 Nov;47(6):796-807. doi: 10.4093/dmj.2022.0315. Epub 2023 Feb 9.'}]}, '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': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects with T2DM aged 19 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': 'NCT04634500', 'acronym': 'ENHANCE-M', 'briefTitle': 'The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'DW_DWP16001302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'DWP16001 A mg, Dapagliflozin placebo', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'DWP16001 A mg placebo, Dapagliflozin', 'interventionNames': ['Drug: Dapagliflozin']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['DWP16001'], 'description': 'Dapagliflozin Tablet', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Soeul', 'country': 'South Korea', 'facility': 'Daewoong pharmatceutical', 'geoPoint': {'lat': 36.9168, 'lon': 126.7319}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}