Viewing Study NCT01376557

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Ignite Creation Date: 2025-12-24 @ 6:44 PM
Ignite Modification Date: 2026-01-02 @ 2:31 AM
Study NCT ID: NCT01376557
Status: COMPLETED
Last Update Posted: 2014-10-31
First Post: 2011-06-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'C575681', 'term': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pstrumph@lexpharma.com', 'phone': '(281) 863-3302', 'title': 'Dr. Paul Strumph', 'organization': 'Lexicon Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'Institutions cannot publish any data generated from the clinical trial until Sponsor publishes such data or until 18 months have elapsed since completion of the clinical trial. Proposed publication must be provided to Sponsor at least 60 days prior to submission for publication and Sponsor has 30 days from receipt to review. Sponsor can delete any info to which it objects, Confidential Information, proprietary information or patentable subject matter from the final version of the publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety population', 'eventGroups': [{'id': 'EG000', 'title': '75 mg LX4211 qd', 'description': 'Subjects will receive 75 mg LX4211 once daily', 'otherNumAtRisk': 57, 'otherNumAffected': 31, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '200 mg LX4211 qd', 'description': 'Subjects will receive 200 mg LX4211 once daily.', 'otherNumAtRisk': 60, 'otherNumAffected': 34, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '400 mg LX4211 qd', 'description': 'Subjects will receive 400 mg LX4211 once daily.', 'otherNumAtRisk': 59, 'otherNumAffected': 26, 'seriousNumAtRisk': 59, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': '200 mg LX4211 Bid', 'description': 'Subjects will receive 200 mg LX4211 twice daily.', 'otherNumAtRisk': 60, 'otherNumAffected': 26, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo qd', 'description': 'Placebo: Subjects will receive placebo once daily.', 'otherNumAtRisk': 60, 'otherNumAffected': 27, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg LX4211 qd', 'description': 'Subjects will receive 75 mg LX4211 once daily'}, {'id': 'OG001', 'title': '200 mg LX4211 qd', 'description': 'Subjects will receive 200 mg LX4211 once daily.'}, {'id': 'OG002', 'title': '400 mg LX4211 qd', 'description': 'Subjects will receive 400 mg LX4211 once daily.'}, {'id': 'OG003', 'title': '200 mg LX4211 Bid', 'description': 'Subjects will receive 200 mg LX4211 twice daily.'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Placebo: Subjects will receive placebo once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.637', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.780', 'groupId': 'OG001'}, {'value': '-0.92', 'spread': '0.873', 'groupId': 'OG002'}, {'value': '-0.80', 'spread': '0.932', 'groupId': 'OG003'}, {'value': '-0.09', 'spread': '0.770', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving a HbA1c Value of <7% at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg LX4211 qd', 'description': 'Subjects will receive 75 mg LX4211 once daily'}, {'id': 'OG001', 'title': '200 mg LX4211 qd', 'description': 'Subjects will receive 200 mg LX4211 once daily.'}, {'id': 'OG002', 'title': '400 mg LX4211 qd', 'description': 'Subjects will receive 400 mg LX4211 once daily.'}, {'id': 'OG003', 'title': '200 mg LX4211 Bid', 'description': 'Subjects will receive 200 mg LX4211 twice daily.'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Placebo: Subjects will receive placebo once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg LX4211 qd', 'description': 'Subjects will receive 75 mg LX4211 once daily'}, {'id': 'OG001', 'title': '200 mg LX4211 qd', 'description': 'Subjects will receive 200 mg LX4211 once daily.'}, {'id': 'OG002', 'title': '400 mg LX4211 qd', 'description': 'Subjects will receive 400 mg LX4211 once daily.'}, {'id': 'OG003', 'title': '200 mg LX4211 Bid', 'description': 'Subjects will receive 200 mg LX4211 twice daily.'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Placebo: Subjects will receive placebo once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.5', 'spread': '27.35', 'groupId': 'OG000'}, {'value': '-17.4', 'spread': '40.45', 'groupId': 'OG001'}, {'value': '-27.1', 'spread': '38.48', 'groupId': 'OG002'}, {'value': '-26.9', 'spread': '35.07', 'groupId': 'OG003'}, {'value': '2.2', 'spread': '45.35', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg LX4211 qd', 'description': 'Subjects will receive 75 mg LX4211 once daily'}, {'id': 'OG001', 'title': '200 mg LX4211 qd', 'description': 'Subjects will receive 200 mg LX4211 once daily.'}, {'id': 'OG002', 'title': '400 mg LX4211 qd', 'description': 'Subjects will receive 400 mg LX4211 once daily.'}, {'id': 'OG003', 'title': '200 mg LX4211 Bid', 'description': 'Subjects will receive 200 mg LX4211 twice daily.'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Placebo: Subjects will receive placebo once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.995', 'spread': '3.1130', 'groupId': 'OG000'}, {'value': '-1.956', 'spread': '2.5360', 'groupId': 'OG001'}, {'value': '-1.848', 'spread': '1.9641', 'groupId': 'OG002'}, {'value': '-2.477', 'spread': '2.5610', 'groupId': 'OG003'}, {'value': '-0.395', 'spread': '1.9813', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SPB) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg LX4211 qd', 'description': 'Subjects will receive 75 mg LX4211 once daily'}, {'id': 'OG001', 'title': '200 mg LX4211 qd', 'description': 'Subjects will receive 200 mg LX4211 once daily.'}, {'id': 'OG002', 'title': '400 mg LX4211 qd', 'description': 'Subjects will receive 400 mg LX4211 once daily.'}, {'id': 'OG003', 'title': '200 mg LX4211 Bid', 'description': 'Subjects will receive 200 mg LX4211 twice daily.'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Placebo: Subjects will receive placebo once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.123', 'spread': '12.6921', 'groupId': 'OG000'}, {'value': '-3.878', 'spread': '12.1935', 'groupId': 'OG001'}, {'value': '-5.746', 'spread': '12.3675', 'groupId': 'OG002'}, {'value': '-4.452', 'spread': '12.1401', 'groupId': 'OG003'}, {'value': '-0.283', 'spread': '13.5945', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Triglycerides at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '75 mg LX4211 qd', 'description': 'Subjects will receive 75 mg LX4211 once daily'}, {'id': 'OG001', 'title': '200 mg LX4211 qd', 'description': 'Subjects will receive 200 mg LX4211 once daily.'}, {'id': 'OG002', 'title': '400 mg LX4211 qd', 'description': 'Subjects will receive 400 mg LX4211 once daily.'}, {'id': 'OG003', 'title': '200 mg LX4211 Bid', 'description': 'Subjects will receive 200 mg LX4211 twice daily.'}, {'id': 'OG004', 'title': 'Placebo qd', 'description': 'Placebo: Subjects will receive placebo once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.2', 'spread': '84.17', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '77.05', 'groupId': 'OG001'}, {'value': '-16.8', 'spread': '121.90', 'groupId': 'OG002'}, {'value': '-16.9', 'spread': '73.13', 'groupId': 'OG003'}, {'value': '-30.5', 'spread': '201.92', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '75 mg LX4211 qd', 'description': 'Subjects will receive 75 mg LX4211 once daily'}, {'id': 'FG001', 'title': '200 mg LX4211 qd', 'description': 'Subjects will receive 200 mg LX4211 once daily.'}, {'id': 'FG002', 'title': '400 mg LX4211 qd', 'description': 'Subjects will receive 400 mg LX4211 once daily.'}, {'id': 'FG003', 'title': '200 mg LX4211 Bid', 'description': 'Subjects will receive 200 mg LX4211 twice daily.'}, {'id': 'FG004', 'title': 'Placebo qd', 'description': 'Placebo: Subjects will receive placebo once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '299', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '75 mg LX4211 qd', 'description': 'Subjects will receive 75 mg LX4211 once daily'}, {'id': 'BG001', 'title': '200 mg LX4211 qd', 'description': 'Subjects will receive 200 mg LX4211 once daily.'}, {'id': 'BG002', 'title': '400 mg LX4211 qd', 'description': 'Subjects will receive 400 mg LX4211 once daily.'}, {'id': 'BG003', 'title': '200 mg LX4211 Bid', 'description': 'Subjects will receive 200 mg LX4211 twice daily.'}, {'id': 'BG004', 'title': 'Placebo qd', 'description': 'Placebo: Subjects will receive placebo once daily.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '9.61', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '9.25', 'groupId': 'BG001'}, {'value': '56.1', 'spread': '9.51', 'groupId': 'BG002'}, {'value': '56.4', 'spread': '8.76', 'groupId': 'BG003'}, {'value': '55.1', 'spread': '9.79', 'groupId': 'BG004'}, {'value': '55.9', 'spread': '9.34', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '164', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '135', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 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[{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '82', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '217', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': 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{'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c to Week 12', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving a HbA1c Value of <7% at Week 12', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline in Body Weight at Week 12', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SPB) at Week 12', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline in Triglycerides at Week 12', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes mellitus'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25216510', 'type': 'DERIVED', 'citation': 'Rosenstock J, Cefalu WT, Lapuerta P, Zambrowicz B, Ogbaa I, Banks P, Sands A. Greater dose-ranging effects on A1C levels than on glucosuria with LX4211, a dual inhibitor of SGLT1 and SGLT2, in patients with type 2 diabetes on metformin monotherapy. Diabetes Care. 2015 Mar;38(3):431-8. doi: 10.2337/dc14-0890. Epub 2014 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects between the ages of 18 to 75 years, inclusive\n* Confirmed diagnosis of Type 2 diabetes mellitus\n* Meet required laboratory values at screening, including fasting plasma glucose less than 270 mg/dL\n* Stable dose of metformin monotherapy greater than 1500 mg/day for at least 8 weeks\n* Willing and able to provide written informed consent\n* Willing and able to maintain consistent dietary, physical activity, and sleeping patterns throughout the study\n\nExclusion Criteria:\n\n* History of 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days of study Day 1\n* Prior exposure to LX4211\n* Use of any medication or herbal supplement for the purpose of weight loss\n* Chronic use of any antidiabetic therapy other than metformin in the 3 months prior to study Day 1\n* Use of corticosteroids within 2 weeks prior to study Day 1\n* Major surgery within 6 months of study Day 1\n* Subjects with any history of severe gastroparesis\n* Inability or difficulty swallowing whole capsules or tablets\n* Women who are pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT01376557', 'briefTitle': 'Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of LX4211 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy', 'orgStudyIdInfo': {'id': 'LX4211.1-202-DM'}, 'secondaryIdInfos': [{'id': 'LX4211.202', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'interventionNames': ['Drug: 75 mg LX4211']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'interventionNames': ['Drug: 200 mg LX4211']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'interventionNames': ['Drug: 400 mg LX4211']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D', 'interventionNames': ['Drug: 200 mg LX4211']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '75 mg LX4211', 'type': 'DRUG', 'description': 'Subjects will receive 75 mg LX4211 once daily', 'armGroupLabels': ['Treatment A']}, {'name': '200 mg LX4211', 'type': 'DRUG', 'description': 'Subjects will receive 200 mg LX4211 once daily.', 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