Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT02949193
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2014-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 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': 'C557982', 'term': '4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2014-02-23', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Change from baseline at 24 week', 'description': 'unit: %'}], 'secondaryOutcomes': [{'measure': 'fasting plasma glucose', 'timeFrame': 'Change from baseline at 24 week', 'description': 'unit : mg/dL'}, {'measure': 'HOMA-beta', 'timeFrame': 'Change from baseline at 24 week', 'description': 'unit: %'}, {'measure': 'HbA1c response rate', 'timeFrame': 'Change from baseline at 24 weeks', 'description': 'unit: %'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control', 'detailedDescription': '1. Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.\n2. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with 6.5%≤HbA1c≤11.0% at screening\n* Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening\n* Subjects with 20kg/m2≤BMI≤40kg/m2 at screening\n\nExclusion Criteria:\n\n* Subjects with fasting plasma glucose≥270mg/dL at screening\n* Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus\n* Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening\n* Subjects with ALT and AST 2.5 times or higher than upper normal range'}, 'identificationModule': {'nctId': 'NCT02949193', 'briefTitle': 'Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'DA1229_DMC_III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'evogliptin', 'description': 'evogliptin 5mg qd add-on to metformin', 'interventionNames': ['Drug: evogliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sitagliptin', 'description': 'sitagliptin 100mg qd add-on to metformin', 'interventionNames': ['Drug: Sitagliptin']}], 'interventions': [{'name': 'evogliptin', 'type': 'DRUG', 'otherNames': ['Suganon'], 'description': 'evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg', 'armGroupLabels': ['evogliptin']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['januvia'], 'description': 'sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg', 'armGroupLabels': ['sitagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-746', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sung Woo Park, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangbuk Samsung Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}