Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT00789750
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2008-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069472', 'term': 'Colesevelam Hydrochloride'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D000499', 'term': 'Allylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000498', 'term': 'Allyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '9089926400', 'title': 'Global Clinical Leader', 'organization': 'Daiichi Sankyo, Inc.'}, 'certainAgreement': {'otherDetails': 'PI agrees to wait until after coordinated multicenter publication or one year after the trial is over, whichever occurs first. After such time, Study Site will submit any publication to DSI for CCI review and comment at least forty-five (45) days prior to submission. Site agrees to delay publication for an additional sixty (60) days for legal (e.g., patent) concerns. Nothing shall be taken as giving DSI any right of editorial control over any publication prepared by Study Site.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events that first occurred or worsened in severity after initiation of treatment with the investigational product and up to the end of study assessment and follow-up period, within 3 years, 3 months', 'description': 'Four potential cardiac events were referred to the Clinical Event Committee (CEC) for adjudication: 1 event was adjudicated as stroke and was considered unrelated to study treatment, while 3 were adjudicated as noncardiac chest pain. No serious adverse events in either treatment group were considered drug-related.', 'eventGroups': [{'id': 'EG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy', 'otherNumAtRisk': 274, 'deathsNumAtRisk': 274, 'otherNumAffected': 11, 'seriousNumAtRisk': 274, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy', 'otherNumAtRisk': 277, 'deathsNumAtRisk': 277, 'otherNumAffected': 17, 'seriousNumAtRisk': 277, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (version?)'}], 'seriousEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 277, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.083', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.084', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.037', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '-0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.037', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat set, with baseline and post-baseline measures at the given time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.056', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '-0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.056', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat set, with baseline and post-baseline measures at the given time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.078', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '-0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.077', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat set, with baseline and post-baseline measures at the given time point'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving an HbA1c Goal of <7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.8', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '3.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.7', 'ciLowerLimit': '-21.93', 'ciUpperLimit': '-7.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.68', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intent-to-treat set with values at both baseline and Week 24 with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Decrease of >= 0.7 Percent in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with last count carried forward'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Decrease of >= 0.5 Percent in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with last count carried forward'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Reduction in FPG of >= 30 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.132', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with last count carried forward'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (TC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'TC is measured in milligrams per deciliter (mg/dL)', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.1', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.4', 'ciLowerLimit': '-20.62', 'ciUpperLimit': '-12.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.15', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'LDL-C is measured in mg/dL', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with values at both baseline and Week 24 with last count carried forward'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1652', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '4.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.31', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'HDL-C is measured in mg/dL', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.8', 'ciLowerLimit': '-13.44', 'ciUpperLimit': '-6.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.85', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Non-HDL-C is measured in mg/dL', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides (TG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '-4.32', 'upperLimit': '32.52'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '-14.6', 'upperLimit': '19.0'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.3', 'ciLowerLimit': '5.3', 'ciUpperLimit': '17.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '67.01', 'estimateComment': 'The treatment difference and its 95% confidence interval are estimated using the Hodges-Lehmann estimator and Moses method. The parameter dispersion Type is actually IQR of the Median Difference.', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 24', 'description': 'TG are measured in mg/dL', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '1.58', 'ciUpperLimit': '5.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.93', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Apo A-1 is measured in mg/dL', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, with values at both baseline and Week 24 with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B (Apo B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.8', 'ciLowerLimit': '-11.75', 'ciUpperLimit': '-5.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.52', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Apo B is measured in mg/dL', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7286', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '2.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.77', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'µIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting C-peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0653', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8862', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.73', 'groupDescription': 'Treatment difference = Colesevelam - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better.', 'unitOfMeasure': 'calculation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '280'}, {'groupId': 'FG001', 'numSubjects': '282'}]}, {'type': 'Dropped During run-in Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '274'}, {'groupId': 'FG001', 'numSubjects': '277'}]}, {'type': 'Intent to Treat Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '276'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '222'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '60'}]}]}], 'recruitmentDetails': 'The safety set includes all randomized participants who took at least one dose of study medication and have at least one post-baseline safety measurement.\n\nThe intent-to-treat set includes all randomized subjects who took at least one dose of study medication, and had a baseline and at least one post-baseline HbA1c or FPG measurement.', 'preAssignmentDetails': 'There was a lead-in period that occurred after participant enrollment, but before randomization.1538 were screened, and a total of 562 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Colesevelam', 'description': 'Colesevelam tablets with pioglitazone therapy'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo tablets with pioglitazone therapy'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '10.22', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '10.61', 'groupId': 'BG001'}, {'value': '56.0', 'spread': '10.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects randomized'}}, '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': 562}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'dispFirstSubmitDate': '2013-08-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-23', 'studyFirstSubmitDate': '2008-11-10', 'dispFirstSubmitQcDate': '2013-08-06', 'resultsFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2008-11-10', 'dispFirstPostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-23', 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24', 'timeFrame': 'Baseline, Week 24'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Week 4', 'timeFrame': 'Baseline, Week 4'}, {'measure': 'Change From Baseline in HbA1c at Week 8', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Change From Baseline in HbA1c at Week 16', 'timeFrame': 'Baseline, Week 16'}, {'measure': 'Number of Participants Achieving an HbA1c Goal of <7.0%', 'timeFrame': 'Week 24'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline, Week 24', 'description': 'In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response.'}, {'measure': 'Number of Participants With a Decrease of >= 0.7 Percent in HbA1c', 'timeFrame': 'Week 24'}, {'measure': 'Number of Participants With a Decrease of >= 0.5 Percent in HbA1c', 'timeFrame': 'Week 24'}, {'measure': 'Number of Participants With a Reduction in FPG of >= 30 mg/dL', 'timeFrame': 'Week 24'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (TC)', 'timeFrame': 'Baseline, Week 24', 'description': 'TC is measured in milligrams per deciliter (mg/dL)'}, {'measure': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline, Week 24', 'description': 'LDL-C is measured in mg/dL'}, {'measure': 'Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': 'Baseline, Week 24', 'description': 'HDL-C is measured in mg/dL'}, {'measure': 'Percent Change From Baseline in Non-HDL-C', 'timeFrame': 'Baseline, Week 24', 'description': 'Non-HDL-C is measured in mg/dL'}, {'measure': 'Percent Change From Baseline in Triglycerides (TG)', 'timeFrame': 'Baseline, Week 24', 'description': 'TG are measured in mg/dL'}, {'measure': 'Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)', 'timeFrame': 'Baseline, Week 24', 'description': 'Apo A-1 is measured in mg/dL'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B (Apo B)', 'timeFrame': 'Baseline, Week 24', 'description': 'Apo B is measured in mg/dL'}, {'measure': 'Change From Baseline in Fasting Insulin Levels', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change From Baseline in Fasting C-peptide', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline, Week 24', 'description': 'HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25054436', 'type': 'DERIVED', 'citation': 'Rosenstock J, Truitt KE, Baz-Hecht M, Ford DM, Tao B, Chou HS. Efficacy and safety of colesevelam in combination with pioglitazone in patients with type 2 diabetes mellitus. Horm Metab Res. 2014 Dec;46(13):943-9. doi: 10.1055/s-0034-1383648. Epub 2014 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Type 2 diabetes mellitus\n* Inadequate glycemic control on a stable dose (at least 2 months prior to screening) of pioglitazone at 30 or 45 mg/day, with or without one or two other oral antidiabetic medications \\[metformin or a sulfonylurea, or dipeptidyl peptidase (DPP-IV) inhibitor\\]\n* Hemoglobin A1c (HbA1c) \\>= 7.5% and =\\< 9.5% at screening\n* Fasting plasma glucose =\\<240 mg/dL at randomization (Week 0/Day 1).\n* Male or female \\>= 18 years of age.\n* Women of childbearing potential must be using an adequate method of contraception as detailed per-protocol\n* Fasting C-peptide level \\>0.5 ng/mL at screening\n* Clinically stable in regards to medical conditions other than type 2 diabetes\n* Concomitant medications are at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period\n\nExclusion Criteria:\n\n* History of Type 1 diabetes and/or history of ketoacidosis\n* History of bowel obstruction\n* History of hypertriglyceridemia-induced pancreatitis\n* Fasting serum triglyceride concentration \\>500 mg/dL\n* History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal motility disorders, major gastrointestinal surgery\n* History of insulin use \\>= 2 weeks duration during the previous 3 months or a total of \\>2 months insulin therapy at any time prior to screening\n* Treatment with bile acid sequestrants, including colesevelam within 3 months prior to screening\n* Female subject who is pregnant or breastfeeding\n* History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening'}, 'identificationModule': {'nctId': 'NCT00789750', 'briefTitle': 'Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of WELCHOL as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus (T2DM)', 'orgStudyIdInfo': {'id': 'WEL-A-U306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colesevelam', 'description': 'Participants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg)', 'interventionNames': ['Drug: Colesevelam', 'Drug: Pioglitazone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)', 'interventionNames': ['Drug: Placebo', 'Drug: Pioglitazone']}], 'interventions': [{'name': 'Colesevelam', 'type': 'DRUG', 'otherNames': ['Welchol'], 'description': 'Colesevelam 625 mg tablets', 'armGroupLabels': ['Colesevelam']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['No drug'], 'description': 'Placebo tablets appearing to be colesevelam', 'armGroupLabels': ['Placebo']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': '30 mg or 45 mg pioglitazone therapy', 'armGroupLabels': ['Colesevelam', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36106', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85614', 'city': 'Green Valley', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 31.85425, 'lon': -110.9937}}, {'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85284', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '72143', 'city': 'Searcy', 'state': 'Arkansas', 'country': 'United 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