Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-01-07 @ 1:59 PM
Study NCT ID:
NCT02947620
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2016-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)
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': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2016-10-26', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'Change in HbA1c after 16 weeks, relative to baseline, between the combination of Metformin 1500 mg and Atorvastatin 40 mg compared to Atorvastatin 40 mg alone'}, {'measure': 'Change in LDL Cholesterol', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'Change in low-density lipoprotein cholesterol (LDL-C) after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg'}], 'secondaryOutcomes': [{'measure': 'Change in LDL-C', 'timeFrame': 'Baseline and 16 weeks', 'description': 'Change in LDL-C after 16 weeks, relative to baseline, between Atorvastatin 40 mg and the combination of Metformin 1500 mg and Atorvastatin 40 mg'}, {'measure': 'Change in HbA1c', 'timeFrame': 'Baseline and 16 weeks', 'description': 'Change in HbA1c after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg'}, {'measure': 'Percentage of subjects reaching the LDL-C treatment goal defined by the NCEP ATP III guideline (<100mg/dL) after 16 weeks of treatment with investigational products', 'timeFrame': '16 weeks'}, {'measure': 'Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products', 'timeFrame': '16 weeks'}, {'measure': 'Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline', 'timeFrame': 'Baseline, 4 weeks, 8 weeks and 12 weeks'}, {'measure': 'Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products', 'timeFrame': 'Baseline and 16 weeks'}, {'measure': 'Change in lipid variables and the associated rate of change', 'timeFrame': 'Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks', 'description': 'Change in lipid variables (HDL-C, TG, TC, non-HDL cholesterol, Apolipoprotein A1, Apolipoprotein B) and the associated rate of change after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline'}, {'measure': 'Change in average fasting plasma glucose (FPG) after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline', 'timeFrame': 'Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks'}, {'measure': 'Change in Insulin, HOMA-β, HOMA-IR after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline.', 'timeFrame': 'Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks'}]}, 'conditionsModule': {'conditions': ['Type II Diabetes', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with Dyslipidemia and Type II Diabetes\n* 19 years later, men and women under the age of 80\n\nExclusion Criteria:\n\n* Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study\n* Subject with type I Diabetes\n* Subject with hypertension which does not controlled by treatment(have blood pressure \\> 180/110mmHg)'}, 'identificationModule': {'nctId': 'NCT02947620', 'briefTitle': 'Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Active-controlled, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia', 'orgStudyIdInfo': {'id': 'DW_MA001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin/Atorvastatin', 'description': 'Metformin/Atorvastatin, QD', 'interventionNames': ['Drug: Metformin/Atorvastatin 1500mg/40mg, QD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Metformin', 'description': 'Metformin, QD', 'interventionNames': ['Drug: Atorvastatin 40mg, QD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Atorvastatin', 'description': 'Atorvastatin, QD', 'interventionNames': ['Drug: Metformin 1500mg, QD']}], 'interventions': [{'name': 'Metformin/Atorvastatin 1500mg/40mg, QD', 'type': 'DRUG', 'armGroupLabels': ['Metformin/Atorvastatin']}, {'name': 'Metformin 1500mg, QD', 'type': 'DRUG', 'armGroupLabels': ['Atorvastatin']}, {'name': 'Atorvastatin 40mg, QD', 'type': 'DRUG', 'armGroupLabels': ['Metformin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}