Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-03-01 @ 5:00 PM
Study NCT ID:
NCT01607294
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2012-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581236', 'term': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'dispFirstSubmitDate': '2015-08-13', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2012-04-26', 'dispFirstSubmitQcDate': '2015-08-27', 'studyFirstSubmitQcDate': '2012-05-29', 'dispFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes', 'timeFrame': '4 weeks', 'description': 'evaluate the change in LDL-C from baseline to various time points'}], 'secondaryOutcomes': [{'measure': 'assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin', 'timeFrame': '4 weeks', 'description': 'evaluate the change in glucose and insulin from baseline to various time points'}, {'measure': 'assess the effect of ETC-1002 versus placebo on measures of insulin sensitivity in subjects with type 2 diabetes', 'timeFrame': '4 weeks', 'description': 'evaluate the change in HOMA-IR from baseline to various time points'}, {'measure': 'assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters', 'timeFrame': '4 weeks', 'description': 'evaluate any changes in safety parameters during the course of the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '24385236', 'type': 'DERIVED', 'citation': 'Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.'}]}, 'descriptionModule': {'briefSummary': 'This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes meeting all of the following:\n* Minimum 6 month history of diabetes prior to screening visit;\n* Fasting C-peptide ≥ 0.8 ng/mL at screening visit;\n* HbA1C at screening visit 7-10%;\n* Fasting glucose from 140-270 mg/dL on Day -7 following washout of all glucose regulating drugs and supplements.\n* BMI at screening visit from 25-35 kg/m2;\n* LDL-C at screening ≥ 100 mg/dL'}, 'identificationModule': {'nctId': 'NCT01607294', 'briefTitle': 'A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Esperion Therapeutics, Inc.'}, 'officialTitle': 'A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '1002-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ETC-1002', 'description': 'ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day', 'interventionNames': ['Drug: ETC-1002']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo daily 4 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ETC-1002', 'type': 'DRUG', 'description': 'ETC-1002 Daily for 4 weeks', 'armGroupLabels': ['ETC-1002']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Daily for 4 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esperion Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}