Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-29 @ 6:53 AM
Study NCT ID:
NCT01280695
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2011-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602 in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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': 'C000619119', 'term': 'MSDC-0602'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jcolca@msdrx.com', 'phone': '269.343.6732', 'title': 'Jerry Colca, PhD', 'organization': 'Metabolic Solutions Development Company'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo capsule once daily', 'otherNumAtRisk': 26, 'otherNumAffected': 2, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MSDC-0602 100 mg', 'description': 'MSDC-0602 capsule 100 mg once daily', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MSDC-0602 250 mg', 'description': 'MSDC-0602 capsule 250 mg once daily', 'otherNumAtRisk': 26, 'otherNumAffected': 1, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MSDC-0602 500 mg', 'description': 'MSDC-0602 capsule 500 mg once daily', 'otherNumAtRisk': 26, 'otherNumAffected': 5, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Pioglitazone 45 mg', 'description': 'Pioglitazone capsule 45 mg once daily', 'otherNumAtRisk': 26, 'otherNumAffected': 4, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo capsule once daily'}, {'id': 'OG001', 'title': 'MSDC-0602 100 mg', 'description': 'MSDC-0602 capsule 100 mg once daily'}, {'id': 'OG002', 'title': 'MSDC-0602 250 mg', 'description': 'MSDC-0602 capsule 250 mg once daily'}, {'id': 'OG003', 'title': 'MSDC-0602 500 mg', 'description': 'MSDC-0602 capsule 500 mg once daily'}, {'id': 'OG004', 'title': 'Pioglitazone 45 mg', 'description': 'Pioglitazone capsule 45 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '8.90', 'groupId': 'OG000', 'lowerLimit': '-12.0', 'upperLimit': '26.0'}, {'value': '-0.5', 'spread': '9.77', 'groupId': 'OG001', 'lowerLimit': '-34.0', 'upperLimit': '19.0'}, {'value': '-20.0', 'spread': '10.06', 'groupId': 'OG002', 'lowerLimit': '-32.0', 'upperLimit': '20.0'}, {'value': '-16.0', 'spread': '9.68', 'groupId': 'OG003', 'lowerLimit': '-37.0', 'upperLimit': '10.0'}, {'value': '-22.0', 'spread': '9.38', 'groupId': 'OG004', 'lowerLimit': '-47.0', 'upperLimit': '-4.0'}]}]}], 'analyses': [{'pValue': '0.4195', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.0', 'ciLowerLimit': '-34.0', 'ciUpperLimit': '14.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0811', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.0', 'ciLowerLimit': '-38.0', 'ciUpperLimit': '4.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0639', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.0', 'ciLowerLimit': '-38.0', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0022', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.0', 'ciLowerLimit': '-50.0', 'ciUpperLimit': '-12.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 28 days', 'description': 'To characterize the reduction in fasting plasma glucose in response to three different doses of MSDC-0602 Tablets as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population:Included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures. The Per-Protocol Population was used for all efficacy measurements.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo capsule once daily'}, {'id': 'OG001', 'title': 'MSDC-0602 100 mg', 'description': 'MSDC-0602 capsule 100 mg once daily'}, {'id': 'OG002', 'title': 'MSDC-0602 250 mg', 'description': 'MSDC-0602 capsule 250 mg once daily'}, {'id': 'OG003', 'title': 'MSDC-0602 500 mg', 'description': 'MSDC-0602 capsule 500 mg once daily'}, {'id': 'OG004', 'title': 'Pioglitazone 45 mg', 'description': 'Pioglitazone capsule 45 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.090', 'groupId': 'OG002'}, {'value': '-0.17', 'spread': '0.088', 'groupId': 'OG003'}, {'value': '-0.14', 'spread': '0.086', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 28 days', 'description': 'To explore the drug effect difference in the reduction in hemoglobin A1c in response to three different doses of MSDC-0602 and pioglitazone (45 mg Actos®) as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo capsule once daily'}, {'id': 'OG001', 'title': 'MSDC-0602 100 mg', 'description': 'MSDC-0602 capsule 100 mg once daily'}, {'id': 'OG002', 'title': 'MSDC-0602 250 mg', 'description': 'MSDC-0602 capsule 250 mg once daily'}, {'id': 'OG003', 'title': 'MSDC-0602 500 mg', 'description': 'MSDC-0602 capsule 500 mg once daily'}, {'id': 'OG004', 'title': 'Pioglitazone 45 mg', 'description': 'Pioglitazone capsule 45 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.267', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.291', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '0.297', 'groupId': 'OG002'}, {'value': '0.17', 'spread': '0.290', 'groupId': 'OG003'}, {'value': '0.54', 'spread': '0.284', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 28 days', 'description': 'To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on hematocrit, body weight, and edema following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo capsule once daily'}, {'id': 'OG001', 'title': 'MSDC-0602 100 mg', 'description': 'MSDC-0602 capsule 100 mg once daily'}, {'id': 'OG002', 'title': 'MSDC-0602 250 mg', 'description': 'MSDC-0602 capsule 250 mg once daily'}, {'id': 'OG003', 'title': 'MSDC-0602 500 mg', 'description': 'MSDC-0602 capsule 500 mg once daily'}, {'id': 'OG004', 'title': 'Pioglitazone 45 mg', 'description': 'Pioglitazone capsule 45 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '0.39', 'groupId': 'OG003'}, {'value': '-1.4', 'spread': '0.38', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 28 days', 'description': 'To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo in hematocrit following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.', 'unitOfMeasure': 'Change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo capsule once daily'}, {'id': 'OG001', 'title': 'MSDC-0602 100 mg', 'description': 'MSDC-0602 capsule 100 mg once daily'}, {'id': 'OG002', 'title': 'MSDC-0602 250 mg', 'description': 'MSDC-0602 capsule 250 mg once daily'}, {'id': 'OG003', 'title': 'MSDC-0602 500 mg', 'description': 'MSDC-0602 capsule 500 mg once daily'}, {'id': 'OG004', 'title': 'Pioglitazone 45 mg', 'description': 'Pioglitazone capsule 45 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.06', 'spread': '1.434', 'groupId': 'OG000'}, {'value': '-1.70', 'spread': '1.561', 'groupId': 'OG001'}, {'value': '-1.11', 'spread': '1.601', 'groupId': 'OG002'}, {'value': '-2.13', 'spread': '1.564', 'groupId': 'OG003'}, {'value': '-3.21', 'spread': '1.523', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 28 days', 'description': 'To characterize the effects of 3 different doses of MSDC-0602 and pioglitazone as compared to placebo on insulin following once-daily dosing for 28 consecutive days', 'unitOfMeasure': 'µIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Molecular Weight Adiponectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo capsule once daily'}, {'id': 'OG001', 'title': 'MSDC-0602 100 mg', 'description': 'MSDC-0602 capsule 100 mg once daily'}, {'id': 'OG002', 'title': 'MSDC-0602 250 mg', 'description': 'MSDC-0602 capsule 250 mg once daily'}, {'id': 'OG003', 'title': 'MSDC-0602 500 mg', 'description': 'MSDC-0602 capsule 500 mg once daily'}, {'id': 'OG004', 'title': 'Pioglitazone 45 mg', 'description': 'Pioglitazone capsule 45 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '15.28', 'groupId': 'OG000'}, {'value': '44.1', 'spread': '17.30', 'groupId': 'OG001'}, {'value': '101.6', 'spread': '17.00', 'groupId': 'OG002'}, {'value': '139.2', 'spread': '16.62', 'groupId': 'OG003'}, {'value': '206.0', 'spread': '16.35', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 28 days', 'description': 'To evaluate the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on biomarkers of inflammatory status (high molecular weight adiponectin) following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo capsule once daily'}, {'id': 'FG001', 'title': 'MSDC-0602 100 mg', 'description': 'MSDC-0602 capsule 100 mg once daily'}, {'id': 'FG002', 'title': 'MSDC-0602 250 mg', 'description': 'MSDC-0602 capsule 250 mg once daily'}, {'id': 'FG003', 'title': 'MSDC-0602 500 mg', 'description': 'MSDC-0602 capsule 500 mg once daily'}, {'id': 'FG004', 'title': 'Pioglitazone 45 mg', 'description': 'Pioglitazone capsule 45 mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted at 15 investigational sites between February 15, 2011 and July 6, 2011.', 'preAssignmentDetails': 'This study consisted of a 14-day placebo lead-in period and a 28-day double-blind treatment period. Eligible patients were randomized following the lead-in period based on a stratification criterion of current metformin use (yes, no) to one of the 5 treatments: MSDC 0602 100 mg, MSDC-0602 250 mg, MSDC-0602 500 mg, pioglitazone 45 mg, or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '129', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo capsule once daily'}, {'id': 'BG001', 'title': 'MSDC-0602 100 mg', 'description': 'MSDC-0602 capsule 100 mg once daily'}, {'id': 'BG002', 'title': 'MSDC-0602 250 mg', 'description': 'MSDC-0602 capsule 250 mg once daily'}, {'id': 'BG003', 'title': 'MSDC-0602 500 mg', 'description': 'MSDC-0602 capsule 500 mg once daily'}, {'id': 'BG004', 'title': 'Pioglitazone 45 mg', 'description': 'Pioglitazone capsule 45 mg once daily'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '8.87', 'groupId': 'BG000'}, {'value': '57.6', 'spread': '8.07', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '7.35', 'groupId': 'BG002'}, {'value': '55.5', 'spread': '8.59', 'groupId': 'BG003'}, {'value': '55.7', 'spread': '8.01', 'groupId': 'BG004'}, {'value': '56.7', 'spread': '8.12', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '129', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-17', 'studyFirstSubmitDate': '2011-01-20', 'resultsFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2011-01-20', 'lastUpdatePostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-30', 'studyFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose', 'timeFrame': 'Baseline and 28 days', 'description': 'To characterize the reduction in fasting plasma glucose in response to three different doses of MSDC-0602 Tablets as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c', 'timeFrame': 'Baseline and 28 days', 'description': 'To explore the drug effect difference in the reduction in hemoglobin A1c in response to three different doses of MSDC-0602 and pioglitazone (45 mg Actos®) as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline and 28 days', 'description': 'To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on hematocrit, body weight, and edema following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.'}, {'measure': 'Change From Baseline in Hematocrit', 'timeFrame': 'Baseline and 28 days', 'description': 'To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo in hematocrit following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.'}, {'measure': 'Change in Fasting Plasma Insulin', 'timeFrame': 'Baseline and 28 days', 'description': 'To characterize the effects of 3 different doses of MSDC-0602 and pioglitazone as compared to placebo on insulin following once-daily dosing for 28 consecutive days'}, {'measure': 'Change From Baseline in High Molecular Weight Adiponectin', 'timeFrame': 'Baseline and 28 days', 'description': 'To evaluate the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on biomarkers of inflammatory status (high molecular weight adiponectin) following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2', 'Diabetes Mellitus', 'Diabetes', 'High blood sugar', 'Blood sugar', 'Blood glucose', 'Glucose'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of MSDC-0602 and to evaluate the reduction in fasting plasma glucose in patients with Type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:\n\nInclusion Criteria:\n\n1. Males and females with Type 2 diabetes (fasting plasma glucose ≥126 mg/dL at screening, glycosylated hemoglobin \\[HbA1c\\] \\>7 and ≤10%, and Insulin C-peptide \\>1 ng/mL). Patients can be naïve to diabetes therapy or if taking metformin should be on a stable dose level for a period of at least 3 months prior to screening visit (no dose limit).\n2. Between the ages of 18-75 years, inclusive.\n3. Females should be either postmenopausal (at least 12 months since last menses) or surgically sterilized (bilateral tubal ligation or hysterectomy). Menopausal status will be verified by a follicle-stimulating hormone (FSH) test. If FSH levels are below 40 mIU/mL, some method of birth control must be used. Those with bilateral tubal ligation must also use a barrier method of birth control. In addition, all females must have a negative pregnancy test at Screen and Day 15 regardless of childbearing potential. For postmenopausal women only, if FSH levels are above 40 mIU/mL and serum pregnancy results are indeterminant, the subject will be assessed as not pregnant.\n\n Males with female partners of child-bearing potential must agree to use adequate contraceptive methods (including a condom, plus one other form of contraception) if engaging in sexual intercourse.\n4. Body Mass Index (BMI) ≥ 25 kg/m2 and ≤ 45 kg/m2 (inclusive).\n5. Willing and able to make a screening visit to the clinic and six visits over a 10 week period.\n6. Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.\n\nSubject Exclusion Criteria:\n\n1. Use of TZDs or diabetes medications other than metformin (generic or Glucophage®) 3 months prior to screening.\n2. History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.\n3. Fasting plasma glucose in excess of 240 mg/dl at screening\n4. History of heart failure (including CHF) or previous cardiovascular event (myocardial infarct, by-pass surgery, or PTCA) within the past 6 months prior to screening.\n5. ALT and/or AST levels that equal or exceed twice the upper limit of normal; bilirubin levels that exceed 2 mg/dL; serum creatinine \\>1.5 mg/dL in men or \\> 1.4 mg/dL in women.\n6. History of nephropathy, neuropathy, or retinopathy within 6 months of screening.\n7. Use of glucocorticoids (oral, injectible, intraarticular, or chronic inhaled) or weight-loss drugs within 3 months of randomization.\n8. Current or recurrent disease that may affect the action, absorption or disposition of the study treatment, or clinical or laboratory assessments.\n9. Current or history of severe or unstable disorder (medical or psychiatric) requiring treatment that may make the patient unlikely to complete the study.\n10. Febrile illness within the 5 days prior to Visit 1.\n11. Known history of HIV, hepatitis B, or hepatitis C.\n12. Clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG.\n13. Blood pressure greater than 160/100 mmHg. Patients with elevated BP (\\<160/100 mmHg) with or without current treatment will be allowed at the discretion of the Principal Investigator (PI) and primary care physician. Individuals with hypertension must have been stabilized to the current treatment regimen for at least 6 weeks prior to screening.\n14. Change in BP or lipid-lowering medication within 6 weeks or change in dose of metformin or thyroid replacement within 3 months prior to screening.\n15. Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds or any of their stated ingredients.\n16. History of alcohol or drug abuse within 6 months of Screening.\n17. Have participated in an investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.\n18. Blood donation of 1 pint or more within 56 days of screening.\n19. Plasmapheresis or plasma donation within 30 days of screening.\n20. Single 12-lead ECG demonstrating a QTcB \\>450 msec at Screening. A single repeat ECG may be done at the Investigator's discretion.\n21. Any surgical or medical condition which may significantly alter the absorption of any drug substance including, but not limited to, any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome.\n22. Evidence of clinically relevant pathology that could interfere with the study results or put the patient's safety at risk.\n23. Malignancy, including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years."}, 'identificationModule': {'nctId': 'NCT01280695', 'briefTitle': 'A Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602 in Type 2 Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Metabolic Solutions Development Company'}, 'officialTitle': 'A Phase 2a, Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSCD-0602 in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'MSDC-0602-C002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule once daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MSDC-0602 100 mg', 'description': 'MSDC-0602 capsule 100 mg once daily', 'interventionNames': ['Drug: MSDC-0602 100 mg']}, {'type': 'EXPERIMENTAL', 'label': 'MSDC-0602 250 mg', 'description': 'MSDC-0602 capsule 250 mg once daily', 'interventionNames': ['Drug: MSDC-0602 250 mg']}, {'type': 'EXPERIMENTAL', 'label': 'MSDC-0602 500 mg', 'description': 'MSDC-0602 capsule 500 mg once daily', 'interventionNames': ['Drug: MSDC-0602 250 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone 45 mg', 'description': 'Pioglitazone capsule 45 mg once daily', 'interventionNames': ['Drug: Pioglitazone']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Capsules', 'armGroupLabels': ['Placebo']}, {'name': 'MSDC-0602 100 mg', 'type': 'DRUG', 'description': 'MSDC-0602 100 mg Capsules', 'armGroupLabels': ['MSDC-0602 100 mg']}, {'name': 'MSDC-0602 250 mg', 'type': 'DRUG', 'description': 'MSDC-0602 250 mg Capsules', 'armGroupLabels': ['MSDC-0602 250 mg']}, {'name': 'MSDC-0602 250 mg', 'type': 'DRUG', 'description': 'MSDC-0602 500 mg Capsules', 'armGroupLabels': ['MSDC-0602 500 mg']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'description': 'Pioglitazone 45 mg Capsules', 'armGroupLabels': ['Pioglitazone 45 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Jerry Colca, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Metabolic Solutions Development Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Metabolic Solutions Development Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}