Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-31 @ 10:10 PM
Study NCT ID:
NCT02126358
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2014-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)
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'}]}}, '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': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2014-03-04', 'studyFirstSubmitQcDate': '2014-04-29', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c change', 'timeFrame': 'Baseline(Day 0) to Treatment (last visit, w24)'}, {'measure': 'LDL-C change rate', 'timeFrame': 'Baseline(Day 0) to Treatment (last visit, w24)'}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Baseline(Day 0) to Treatment (last visit, w24)', 'description': '(Gemigliptin/Rosuvastatin FDC vs. Gemigliptin)'}, {'measure': 'LDL-C change rate', 'timeFrame': 'Baseline(Day 0) to Treatment (last visit, w24)', 'description': '(Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus with Dyslipidemia\n* Adults who are at least 19 years old\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma\n* Patients with gestational diabetes or secondary diabetes\n* Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment\n* Patients with thyroid gland dysfunction deviating from the normal TSH range\n* Patients with pituitary insufficiency or adrenal insufficiency'}, 'identificationModule': {'nctId': 'NCT02126358', 'briefTitle': 'Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of the Fix-dose Combination Therapy With Gemigliptin 50mg and Rosuvastatin 20mg With Type 2 Diabetes and Dyslipidemia', 'orgStudyIdInfo': {'id': 'LG-GSCL002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Gemigliptin', 'description': 'only Gemiglitpin (Gemiglitpin/Rosuvastatin FDC:Placebo , Rosuvastatin :Placebo)', 'interventionNames': ['Drug: Gemigliptin and/or Rosuvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Rosuvastatin', 'description': 'only Rosuvastatin (Gemiglitpin/Rosuvastatin FDC:Placebo , gemigliptin :Placebo)', 'interventionNames': ['Drug: Gemigliptin and/or Rosuvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'FDC', 'description': 'Gemigliptin \\& Rosuvastatin (Gemiglitpin only:Placebo ,Rosuvastatin only:Placebo)', 'interventionNames': ['Drug: Gemigliptin and/or Rosuvastatin']}], 'interventions': [{'name': 'Gemigliptin and/or Rosuvastatin', 'type': 'DRUG', 'armGroupLabels': ['FDC', 'Gemigliptin', 'Rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}