Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-01 @ 11:01 PM
Study NCT ID:
NCT00501592
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2007-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C464660', 'term': 'obeticholic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'csciacca@interceptpharma.com', 'phone': '858-652-6800', 'title': 'Cathi Sciacca, Sr. Director, Clinical Operations', 'organization': 'Intercept Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'All proposed publications based on this study shall be approved by the Sponsor prior to submission for publication. Such approval will not be unreasonably witheld. Publications will reflect the contributions made by the Investigators, Sponsor personnel and other groups involved in the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'One year, 7 monhts', 'eventGroups': [{'id': 'EG000', 'title': '25 mg INT-747', 'description': 'Once daily by mouth', 'otherNumAtRisk': 20, 'otherNumAffected': 6, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '50 mg INT-747', 'description': 'Once daily by mouth', 'otherNumAtRisk': 21, 'otherNumAffected': 15, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Once daily by mouth', 'otherNumAtRisk': 23, 'otherNumAffected': 13, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vessel Puncture Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash maculopapular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Resistance and Glucose Homeostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg INT-747', 'description': 'Once daily by mouth'}, {'id': 'OG001', 'title': '50 mg INT-747', 'description': 'Once daily by mouth'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once daily by mouth'}], 'classes': [{'title': 'Low Dose Insulin', 'categories': [{'measurements': [{'value': '.69', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '.24', 'spread': '1.62', 'groupId': 'OG001'}, {'value': '-0.51', 'spread': '1.88', 'groupId': 'OG002'}]}]}, {'title': 'High Dose Insulin', 'categories': [{'measurements': [{'value': '.73', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '.42', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '1.88', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.040', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 25 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.28', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 50 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 weeks', 'description': 'The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).', 'unitOfMeasure': 'mg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hepatocellular Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg INT-747', 'description': 'Once daily by mouth'}, {'id': 'OG001', 'title': '50 mg INT-747', 'description': 'Once daily by mouth'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once daily by mouth'}], 'classes': [{'title': 'ALT', 'categories': [{'measurements': [{'value': '-9', 'spread': '14', 'groupId': 'OG000'}, {'value': '9', 'spread': '47', 'groupId': 'OG001'}, {'value': '11', 'spread': '48', 'groupId': 'OG002'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '-3', 'spread': '7', 'groupId': 'OG000'}, {'value': '4', 'spread': '24', 'groupId': 'OG001'}, {'value': '4', 'spread': '46', 'groupId': 'OG002'}]}]}, {'title': 'GGT', 'categories': [{'measurements': [{'value': '-39', 'spread': '77', 'groupId': 'OG000'}, {'value': '-23', 'spread': '56', 'groupId': 'OG001'}, {'value': '5', 'spread': '27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0031', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.05', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 weeks', 'description': 'Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '25 mg INT-747', 'description': 'Once daily by mouth'}, {'id': 'FG001', 'title': '50 mg INT-747', 'description': 'Once daily by mouth'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Once daily by mouth'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Sixty four subjects were enrolled in the study at 4 sites. Of the randomized subjects, 20 were randomized to INT-747 25 mg, 21 subjects to INT-747 50 mg, and 23 subjects to placebo. Study enrollment by center ranged from 4 to 31 subjects.', 'preAssignmentDetails': 'A protocol amendment allowed for the enrollment of 14 replacement subjects (to enroll up to 56 subjects meeting eligibility requirements). The amendment pre-specified that the original 14 subjects being replaced would not be included in the efficacy analysis since they did not meet the protocol requirements.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '25 mg INT-747', 'description': 'Once daily by mouth'}, {'id': 'BG001', 'title': '50 mg INT-747', 'description': 'Once daily by mouth'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Once daily by mouth'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '50.5', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '53.1', 'spread': '12.1', 'groupId': 'BG002'}, {'value': '52.1', 'spread': '10.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-17', 'studyFirstSubmitDate': '2007-07-13', 'resultsFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2007-07-13', 'lastUpdatePostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-21', 'studyFirstPostDateStruct': {'date': '2007-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Resistance and Glucose Homeostasis', 'timeFrame': 'baseline and 6 weeks', 'description': 'The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).'}], 'secondaryOutcomes': [{'measure': 'Hepatocellular Function', 'timeFrame': 'baseline and 6 weeks', 'description': 'Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Farnesoid X receptor agonist', 'Metabolic Disorder', 'Diabetes', 'NAFLD'], 'conditions': ['Diabetes Mellitus, Type II', 'Fatty Liver']}, 'referencesModule': {'references': [{'pmid': '23727264', 'type': 'DERIVED', 'citation': 'Mudaliar S, Henry RR, Sanyal AJ, Morrow L, Marschall HU, Kipnes M, Adorini L, Sciacca CI, Clopton P, Castelloe E, Dillon P, Pruzanski M, Shapiro D. Efficacy and safety of the farnesoid X receptor agonist obeticholic acid in patients with type 2 diabetes and nonalcoholic fatty liver disease. Gastroenterology. 2013 Sep;145(3):574-82.e1. doi: 10.1053/j.gastro.2013.05.042. Epub 2013 May 30.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:\n\n* The safety and tolerability of multiple doses of INT 747;\n* The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis;\n* Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and;\n* Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.', 'detailedDescription': 'This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.\n\nThe primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes, defined by the American Diabetes Association (ADA), as one of the following criteria:\n* Symptoms of diabetes plus casual plasma glucose concentration \\>200 mg/dL (11.1 mmol/L) or\n* Fasting plasma glucose \\>126 mg/dL (7.0 mmol/L) or\n* 2-hour post-load glucose \\>200 mg/dL (11.1 mmol/L) during a 75 g oral glucose tolerance test (GTT).\n* Presumed NAFLD, defined by one of the following criteria:\n* Alanine aminotransferase (ALT) ≥47 U/L for females and ≥56 U/L for males\n* Aspartate aminotransferase (AST) ≥47 U/L for females and ≥60 U/L for males\n* Enlarged liver (demonstrated by ultrasound or other imaging technique)\n* Diagnostic histological findings shown on prior biopsy (in the last 5 years).\n\nExclusion Criteria:\n\n* Bilirubin \\>2 × ULN\n* ALT \\>155 U/L for females and \\>185 U/L for males.\n* AST \\>155 U/L for females and \\>200 U/L for males.\n* Patients taking any antidiabetic medications, with the exception of metformin and sulfonylureas. If the HbA1c is \\<11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the Principal Investigator.'}, 'identificationModule': {'nctId': 'NCT00501592', 'briefTitle': 'Study of INT-747 in Patients With Diabetes and Presumed NAFLD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intercept Pharmaceuticals'}, 'officialTitle': 'An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': '747-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '25 mg INT-747', 'interventionNames': ['Drug: INT-747']}, {'type': 'ACTIVE_COMPARATOR', 'label': '50 mg INT-747', 'interventionNames': ['Drug: INT-747']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'INT-747', 'type': 'DRUG', 'description': '25 mg by mouth once daily, 50 mg by mouth once daily', 'armGroupLabels': ['25 mg INT-747', '50 mg INT-747']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research, Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego VAMC', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diabetes & Glandular Disease Research Associates, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwelath University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'David A Shapiro, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Intercept Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intercept Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}