Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05376969
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2022-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin
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': 'C000729921', 'term': 'Enavogliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-23', 'studyFirstSubmitDate': '2022-01-09', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP', 'timeFrame': 'at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP', 'description': '\\*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP', 'timeFrame': 'at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP', 'description': '\\* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\\_DWP16001302)'}, {'measure': 'Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP', 'timeFrame': 'at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP', 'description': '\\* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\\_DWP16001302)'}, {'measure': 'Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP', 'timeFrame': 'at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP', 'description': '\\* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\\_DWP16001302)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['T2DM (Type 2 Diabetes Mellitus)']}, 'descriptionModule': {'briefSummary': 'A Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately controlled on metformin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participated in the prior phase 3 study (Protocol No: DW\\_DWP16001302) for meeting the inclusion criteria and completed the study\n* Voluntarily decided to participate in the extension study and provided a written consent on the consent form\n\nExclusion Criteria:\n\n* Withdrawn from the prior phase 3 study (Protocol No: DW\\_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator\n* Subjects with the following diseases or signs:\n\n * Diabetic ketoacidosis\n * Moderate to severe renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\< 60 mL/min/1.73 m2\n* Females who are pregnant or breast-feeding, or subjects who do not agree to the use of appropriate contraceptive methods throughout the study\n\nSubjects must agree to one of the following appropriate contraceptive methods for subjects or their partners:\n\n① Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or\n\n② A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or\n\n③ Use of male condom combined with either cervical cap or diaphragm Determined to be ineligible for the study by the investigator, besides the above'}, 'identificationModule': {'nctId': 'NCT05376969', 'acronym': 'ENHANCE-MEXT', 'briefTitle': 'Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Multi-center, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin', 'orgStudyIdInfo': {'id': 'DW_DWP16001302_Ext'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWP16001 Amg', 'description': 'DWP16001 Amg, Tablets, Orally, Once daily', 'interventionNames': ['Drug: DWP16001']}], 'interventions': [{'name': 'DWP16001', 'type': 'DRUG', 'description': 'DWP16001 Tablets', 'armGroupLabels': ['DWP16001 Amg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Daewoong pharmatceutical', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}