Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT02974504
Status:
COMPLETED
Last Update Posted:
2018-07-23
First Post:
2016-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C557982', 'term': '4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one'}, {'id': 'D000069476', 'term': 'Linagliptin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2016-11-23', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Change from baseline at 12 week', 'description': 'unit: %'}], 'secondaryOutcomes': [{'measure': 'fasting plasma glucose', 'timeFrame': 'Change from baseline at 12 week', 'description': 'unit : mg/dL'}, {'measure': 'HbA1c response rate', 'timeFrame': 'Change from baseline at 12 weeks', 'description': 'unit: %'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes']}, 'descriptionModule': {'briefSummary': 'A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV clinical trial to investigate the effect on blood glucose of evogliptin after oral administration in patients with type 2 diabetes', 'detailedDescription': '1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-24 weeks.\n2. Liniagliptin 5mg Group: Administration with linagliptin 5mg for 0-12 weeks, and with Evogliptin 5mg for 13-24 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with 7.0%≤HbA1c≤10.0% at screening\n\n * Subjects untreated with oral hypoglycemic agents within 8 weeks prior to 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 24 weeks prior to screening\n* Subjects with ALT and AST 3 times or higher than upper normal range'}, 'identificationModule': {'nctId': 'NCT02974504', 'briefTitle': 'Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Active-contrelled, Parallel-group, Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin After Oral Administration in Patiend With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'DA1229_DM_IV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'evogliptin', 'description': 'evogliptin 5mg qd', 'interventionNames': ['Drug: evogliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'linagliptin', 'description': 'linagliptin 5mg qd', 'interventionNames': ['Drug: Linagliptin']}], 'interventions': [{'name': 'evogliptin', 'type': 'DRUG', 'description': 'evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg', 'armGroupLabels': ['evogliptin']}, {'name': 'Linagliptin', 'type': 'DRUG', 'otherNames': ['Tragenta'], 'description': 'linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg', 'armGroupLabels': ['linagliptin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}