Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT03910361
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2019-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557982', 'term': '4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline intrahepatic fat (%)', 'timeFrame': '24 weeks', 'description': 'Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes', 'Non-Alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'A multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and non-alcoholic fatty liver diseases', 'detailedDescription': '1. Evogliptin 5mg Group: Administration with Evogliptin 5mg and Placebo for 24weeks\n2. Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type II diabetes mellitus\n* Subjects who have not been taking any oral hypoglycemic agent within 8 weeks from screening or who have been taking metformin monotherapy at the same dose for more than 8 weeks before screening\n* Subjects with 6.5%≤HbA1c≤9.0% at screening\n* Subjects with 20kg/m2≤BMI≤40kg/m2 at screening\n\nExclusion Criteria:\n\n* Type I diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus\n* AST \\> upper normal range\\*3\n* Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption\n* Subjects who experienced hypersensitivity reaction against DPP-4 inhibitors, thiazolidinediones\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT03910361', 'briefTitle': 'Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases', 'orgStudyIdInfo': {'id': 'DA1229_NAFLD_IV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evogliptin', 'description': 'evogliptin 5mg', 'interventionNames': ['Drug: Evogliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone', 'description': 'pioglitazone 15mg', 'interventionNames': ['Drug: Pioglitazone']}], 'interventions': [{'name': 'Evogliptin', 'type': 'DRUG', 'otherNames': ['Suganon'], 'description': 'evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd', 'armGroupLabels': ['Evogliptin']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Gluconon'], 'description': 'pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd', 'armGroupLabels': ['Pioglitazone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changwon', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung Dongsan University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Guri-si', 'country': 'South Korea', 'facility': 'Hanyang University Guri Hospital', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Catholic University of Seoul ST.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Byung Wan Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}