Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-18 @ 10:18 PM
Study NCT ID:
NCT02827903
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2016-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], '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'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-05', 'studyFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-C (% change)', 'timeFrame': '16 weeks from baseline'}, {'measure': 'change of HbA1c', 'timeFrame': '16 weeks from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metformin', 'Rosuvastatin', 'type 2 diabetes', 'dyslipidemia'], 'conditions': ['Type 2 Diabetes', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia', 'detailedDescription': 'Multi-center, Randomized, Double-blind, Phase III clinical trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 19 years\n* Type II DM with Dyslipidemia\n* 6.5% ≤ HbA1c \\< 11%\n* Triglyceride \\< 350mg/dL\n* 100mg/dL ≤ LDL-C ≤ 250mg/dL\n* FPG ≤ 270mg/dL\n\nExclusion Criteria:\n\n* Type I DM\n* Unstable angina, MI, Stroke, CABG with 6 month from screening\n* SBP ≥ 180mmHg, DBP ≥ 110mmHg\n* TSH \\> UNL\n* Heart failure (NYHA class III/IV)\n* Serum Creatinine \\> UNL or CLCr \\< 60 mL/min\n* CK ≥ 2x UNL\n* HIV positive\n* BMI \\> 40 kg/m\\^2'}, 'identificationModule': {'nctId': 'NCT02827903', 'briefTitle': 'Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jeil Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia', 'orgStudyIdInfo': {'id': 'JLP-1310-P3-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia', 'interventionNames': ['Drug: Metformin + Rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'Metformin + placebo, Dosing to Type II DM with Dyslipidemia', 'interventionNames': ['Drug: Metformin + placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III', 'description': 'Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia', 'interventionNames': ['Drug: placebo + Rosuvastatin']}], 'interventions': [{'name': 'Metformin + Rosuvastatin', 'type': 'DRUG', 'description': 'Group I: Metformin + Rosuvastatin,', 'armGroupLabels': ['Group I']}, {'name': 'Metformin + placebo', 'type': 'DRUG', 'description': 'Group II: Metformin + placebo,', 'armGroupLabels': ['Group II']}, {'name': 'placebo + Rosuvastatin', 'type': 'DRUG', 'description': 'Group III: placebo + Rosuvastatin', 'armGroupLabels': ['Group III']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'country': 'South Korea', 'facility': "Buchoen St. mary's Hospital", 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'SeJong Hostpital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'SoonChunHyang University Bucheon Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'InJe University Busan paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Haeundae paik hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Youngnam University Hostpital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Daeheon Eulji Medical Center', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'KonYang University Hostpital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chosun University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'BunDang Jesang Hospital(DMC)', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'HanYang University Guri Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Inje University Ilsan paik hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Myoung Ji Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon Gil Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': "Inchoen St. mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji Hospital Nowon', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Kangnam Sacred Heart hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'KangBuk SamSung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'KonKuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'KyungHee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital(Famlily medicine)', '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}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'SoonChunHayng University Hospital Seoul', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The catholic University of Korea YEOUIDO St mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Soeul', 'country': 'South Korea', 'facility': 'Korea University Guro hospital', 'geoPoint': {'lat': 36.9168, 'lon': 126.7319}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Wonju Severance Christian hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeil Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}