Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-28 @ 6:49 PM
Study NCT ID:
NCT00727857
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2008-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003923', 'term': 'Diabetes Mellitus, Lipoatrophic'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D008687', 'term': 'Metformin'}], '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'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Sr. VP Clinical Science', 'organization': 'Takeda Global Research and Development Center, Inc.'}, 'certainAgreement': {'otherDetails': "The sponsor can review results communications prior to public release and can embargo trial results communications up to 150 days to permit actions necessary to preserve sponsor's intellectual property. Sponsor can request changes to the results communication only for the purpose of removing non study related information that is proprietary and confidential to sponsor. Sponsor can require delay of a results communication until the study has been completed at all participating sites.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.', 'description': 'One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.', 'eventGroups': [{'id': 'EG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks', 'otherNumAtRisk': 201, 'otherNumAffected': 84, 'seriousNumAtRisk': 201, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks', 'otherNumAtRisk': 190, 'otherNumAffected': 61, 'seriousNumAtRisk': 190, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.', 'otherNumAtRisk': 209, 'otherNumAffected': 95, 'seriousNumAtRisk': 209, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Glycosylated haemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Glycosylated Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.83', 'spread': '0.122', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '0.131', 'groupId': 'OG001'}, {'value': '-0.99', 'spread': '0.120', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.22', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way Analysis of Covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.18', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8919', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.33', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. Last Observation Carried Forward (LOCF) for missing final/week 24 visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.9', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '-22.2', 'spread': '3.67', 'groupId': 'OG001'}, {'value': '-24.8', 'spread': '3.42', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '17.8', 'ciLowerLimit': '7.8', 'ciUpperLimit': '27.7', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '15.1', 'ciLowerLimit': '5.5', 'ciUpperLimit': '24.7', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5981', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-12.5', 'ciUpperLimit': '7.2', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.91', 'spread': '0.736', 'groupId': 'OG000'}, {'value': '-3.18', 'spread': '0.812', 'groupId': 'OG001'}, {'value': '-0.98', 'spread': '0.722', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '2.88', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0047', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '2.93', 'ciLowerLimit': '0.90', 'ciUpperLimit': '4.95', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0435', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '2.20', 'ciLowerLimit': '0.06', 'ciUpperLimit': '4.33', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline.', 'unitOfMeasure': 'μIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Homeostasis Model Assessment - Insulin Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.704', 'spread': '0.4274', 'groupId': 'OG000'}, {'value': '-2.075', 'spread': '0.4586', 'groupId': 'OG001'}, {'value': '-1.085', 'spread': '0.4123', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.629', 'ciLowerLimit': '-0.602', 'ciUpperLimit': '1.861', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0067', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.619', 'ciLowerLimit': '0.452', 'ciUpperLimit': '2.785', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1094', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.989', 'ciLowerLimit': '-0.223', 'ciUpperLimit': '2.201', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Homeostasis Model Assessment of Insulin Resistance collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Resistance collected at baseline. Homeostasis Model Assessment measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5).', 'unitOfMeasure': 'percent of insulin resistance', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit'}, {'type': 'SECONDARY', 'title': 'Median Percent Change From Baseline in High Sensitivity C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.7', 'spread': '4.6719', 'groupId': 'OG000', 'lowerLimit': '-97.7', 'upperLimit': '2060.0'}, {'value': '-34.0', 'spread': '8.1275', 'groupId': 'OG001', 'lowerLimit': '-98.9', 'upperLimit': '2314.6'}, {'value': '-26.2', 'spread': '12.5526', 'groupId': 'OG002', 'lowerLimit': '-99.5', 'upperLimit': '1636.3'}]}]}], 'analyses': [{'pValue': '0.5963', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '4.88', 'ciLowerLimit': '-4.71', 'ciUpperLimit': '13.97', 'estimateComment': 'The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.', 'groupDescription': "Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0265', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '12.81', 'ciLowerLimit': '2.88', 'ciUpperLimit': '22.24', 'estimateComment': 'The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.', 'groupDescription': "Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1053', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '8.33', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '18.07', 'estimateComment': 'The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.', 'groupDescription': "Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Measurement for High Sensitivity C-reactive Protein was collected at final visit or week 24 and at baseline. Percent change from baseline is calculated as: \\[(Week 24 - baseline levels)/baseline\\]\\*100', 'unitOfMeasure': 'percent', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Adiponectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.55', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0806', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '3.1', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-8.1', 'ciLowerLimit': '-9.6', 'ciUpperLimit': '-6.5', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-9.5', 'ciLowerLimit': '-11.1', 'ciUpperLimit': '-7.9', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.', 'unitOfMeasure': 'mcg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'spread': '1.183', 'groupId': 'OG000'}, {'value': '4.79', 'spread': '1.271', 'groupId': 'OG001'}, {'value': '-2.72', 'spread': '1.169', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0324', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '3.73', 'ciLowerLimit': '0.31', 'ciUpperLimit': '7.14', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0233', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-3.78', 'ciLowerLimit': '-7.05', 'ciUpperLimit': '-0.52', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-7.51', 'ciLowerLimit': '-10.90', 'ciUpperLimit': '-4.12', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Low-Density Lipoprotein Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'spread': '2.015', 'groupId': 'OG000'}, {'value': '6.08', 'spread': '2.175', 'groupId': 'OG001'}, {'value': '-1.37', 'spread': '1.998', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0993', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '4.90', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '10.72', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3670', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-2.56', 'ciLowerLimit': '-8.14', 'ciUpperLimit': '3.01', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0119', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-7.46', 'ciLowerLimit': '-13.26', 'ciUpperLimit': '-1.66', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High-Density Lipoprotein Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.20', 'spread': '1.440', 'groupId': 'OG000'}, {'value': '9.88', 'spread': '1.552', 'groupId': 'OG001'}, {'value': '6.09', 'spread': '1.426', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0423', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.31', 'ciLowerLimit': '-8.48', 'ciUpperLimit': '-0.15', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-8.10', 'ciLowerLimit': '-12.08', 'ciUpperLimit': '-4.12', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.728', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-3.79', 'ciLowerLimit': '-7.93', 'ciUpperLimit': '0.35', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.95', 'spread': '2.901', 'groupId': 'OG000'}, {'value': '-5.54', 'spread': '3.107', 'groupId': 'OG001'}, {'value': '-1.78', 'spread': '2.871', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9231', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '-7.94', 'ciUpperLimit': '8.76', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3082', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '4.16', 'ciLowerLimit': '-3.86', 'ciUpperLimit': '12.19', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3753', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '3.75', 'ciLowerLimit': '-4.56', 'ciUpperLimit': '12.07', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Low Density Lipoprotein Particle Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-240.6', 'spread': '23.50', 'groupId': 'OG000'}, {'value': '-217.2', 'spread': '25.40', 'groupId': 'OG001'}, {'value': '-176.4', 'spread': '23.36', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '23.4', 'ciLowerLimit': '-44.6', 'ciUpperLimit': '91.4', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0531', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '64.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '129.3', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2369', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '40.9', 'ciLowerLimit': '-26.9', 'ciUpperLimit': '108.7', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Low Density Lipoprotein Particle Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.053', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.049', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.19', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. 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LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.34', 'spread': '0.285', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.308', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.283', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '1.10', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.43', 'ciLowerLimit': '-2.22', 'ciUpperLimit': '-0.64', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.71', 'ciLowerLimit': '-2.53', 'ciUpperLimit': '-0.89', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.78', 'spread': '0.349', 'groupId': 'OG000'}, {'value': '-3.41', 'spread': '0.377', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.347', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.63', 'ciLowerLimit': '-2.64', 'ciUpperLimit': '-0.62', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '1.01', 'ciUpperLimit': '2.94', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '3.60', 'ciLowerLimit': '2.59', 'ciUpperLimit': '4.61', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.78', 'spread': '2.204', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '2.381', 'groupId': 'OG001'}, {'value': '-11.30', 'spread': '2.191', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '3.76', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '10.14', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. 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LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-12.29', 'ciLowerLimit': '-18.65', 'ciUpperLimit': '-5.93', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Very Low Density Lipoprotein Particle Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.64', 'spread': '0.616', 'groupId': 'OG000'}, {'value': '-3.79', 'spread': '0.666', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '0.612', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-2.93', 'ciUpperLimit': '0.64', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. 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LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Large-Chylomicrons Very Low Density Lipoprotein collected at final visit or week 24 and Large-Chylomicrons Very Low Density Lipoprotein collected at baseline', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.07', 'spread': '1.434', 'groupId': 'OG000'}, {'value': '-3.01', 'spread': '1.550', 'groupId': 'OG001'}, {'value': '-6.48', 'spread': '1.426', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6150', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '5.21', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2346', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-2.41', 'ciLowerLimit': '-6.38', 'ciUpperLimit': '1.57', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. 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LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Medium-Intermediate Very Low Density Lipoprotein collected at final visit or week 24 and Medium-Intermediate Very Low Density Lipoprotein collected at baseline', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg/Metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'OG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.05', 'spread': '1.249', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '1.350', 'groupId': 'OG001'}, {'value': '-2.86', 'spread': '1.239', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '2.86', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '6.48', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - pioglitazone', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-5.90', 'ciLowerLimit': '-9.36', 'ciUpperLimit': '-2.44', 'estimateComment': 'Mean Difference = Pioglitazone \\& metformin - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-8.76', 'ciLowerLimit': '-12.36', 'ciUpperLimit': '-5.16', 'estimateComment': 'Mean Difference = Pioglitazone - metformin', 'groupDescription': 'One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'FG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'FG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '189'}, {'groupId': 'FG002', 'numSubjects': '210'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '125'}, {'groupId': 'FG002', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '68'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 134 investigative sites in the United States (including Puerto Rico), Argentina, Chile, Guatemala, Mexico and Peru from 13 June 2007 to 29 August 2008.', 'preAssignmentDetails': 'Participants who had not received treatment with antidiabetic medication 12 weeks prior to Screening were enrolled in one of three, twice-daily (BID) treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}, {'value': '600', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Pioglitazone 15 mg/Metformin 850 mg BID', 'description': 'Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks'}, {'id': 'BG001', 'title': 'Pioglitazone 15 mg BID', 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks'}, {'id': 'BG002', 'title': 'Metformin 850 mg BID', 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '12.23', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '12.08', 'groupId': 'BG001'}, {'value': '53.7', 'spread': '12.00', 'groupId': 'BG002'}, {'value': '54.1', 'spread': '12.09', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '356', 'groupId': 'BG003'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.84', 'spread': '5.74', 'groupId': 'BG000'}, {'value': '31.18', 'spread': '5.50', 'groupId': 'BG001'}, {'value': '30.83', 'spread': '5.66', 'groupId': 'BG002'}, {'value': '30.94', 'spread': '5.63', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-27', 'studyFirstSubmitDate': '2008-07-30', 'resultsFirstSubmitDate': '2009-08-28', 'studyFirstSubmitQcDate': '2008-07-30', 'lastUpdatePostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-15', 'studyFirstPostDateStruct': {'date': '2008-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Glycosylated Hemoglobin', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Insulin', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline.'}, {'measure': 'Change From Baseline in Homeostasis Model Assessment - Insulin Resistance', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Homeostasis Model Assessment of Insulin Resistance collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Resistance collected at baseline. Homeostasis Model Assessment measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5).'}, {'measure': 'Median Percent Change From Baseline in High Sensitivity C-reactive Protein', 'timeFrame': 'Baseline and Week 24', 'description': 'Measurement for High Sensitivity C-reactive Protein was collected at final visit or week 24 and at baseline. Percent change from baseline is calculated as: \\[(Week 24 - baseline levels)/baseline\\]\\*100'}, {'measure': 'Change From Baseline in Adiponectin', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.'}, {'measure': 'Change From Baseline in Total Cholesterol', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline.'}, {'measure': 'Change From Baseline in Low-Density Lipoprotein Cholesterol', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline.'}, {'measure': 'Change From Baseline in High-Density Lipoprotein Cholesterol', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline.'}, {'measure': 'Change From Baseline in Triglycerides', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.'}, {'measure': 'Change From Baseline in Mean Low Density Lipoprotein Particle Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline.'}, {'measure': 'Change From Baseline in Mean Low Density Lipoprotein Particle Size', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Low Density Lipoprotein collected at final visit or week 24 and Low Density Lipoprotein collected at baseline.'}, {'measure': 'Change From Baseline in Large Low Density Lipoprotein (L3) Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Large Low Density Lipoprotein collected at final visit or week 24 and Large Low Density Lipoprotein collected at baseline.'}, {'measure': 'Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Intermediate-Density Low Density Lipoprotein collected at final visit or week 24 and Intermediate-Density Low Density Lipoprotein collected at baseline'}, {'measure': 'Change From Baseline in Medium-Small Low Density Lipoprotein Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Medium-Small Low Density Lipoprotein collected at final visit or week 24 and Medium-Small Low Density Lipoprotein collected at baseline'}, {'measure': 'Change From Baseline in Small Low Density Lipoprotein Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Small Low Density Lipoprotein collected at final visit or week 24 and Small Low Density Lipoprotein collected at baseline'}, {'measure': 'Change From Baseline in Very Small Low Density Lipoprotein Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Very Small Low Density Lipoprotein collected at final visit or week 24 and Very Small Low Density Lipoprotein collected at baseline'}, {'measure': 'Change From Baseline in Mean High Density Lipoprotein Particle Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.'}, {'measure': 'Change From Baseline in Mean High Density Lipoprotein Particle Size', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.'}, {'measure': 'Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline'}, {'measure': 'Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline'}, {'measure': 'Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline'}, {'measure': 'Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.'}, {'measure': 'Change From Baseline in Mean Very Low Density Lipoprotein Particle Size', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.'}, {'measure': 'Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Large-Chylomicrons Very Low Density Lipoprotein collected at final visit or week 24 and Large-Chylomicrons Very Low Density Lipoprotein collected at baseline'}, {'measure': 'Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Medium-Intermediate Very Low Density Lipoprotein collected at final visit or week 24 and Medium-Intermediate Very Low Density Lipoprotein collected at baseline'}, {'measure': 'Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration', 'timeFrame': 'Baseline and Week 24', 'description': 'The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glucose Metabolism Disorder', 'Dysmetabolic Syndrome', 'Type II Diabetes', 'Diabetes Mellitus, Lipoatrophic', 'Dyslipidemia', 'Drug Therapy'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '19827910', 'type': 'BACKGROUND', 'citation': 'Perez A, Zhao Z, Jacks R, Spanheimer R. Efficacy and safety of pioglitazone/metformin fixed-dose combination therapy compared with pioglitazone and metformin monotherapy in treating patients with T2DM. Curr Med Res Opin. 2009 Dec;25(12):2915-23. doi: 10.1185/03007990903350011.'}, {'pmid': '21122063', 'type': 'RESULT', 'citation': 'Perez A, Jacks R, Arora V, Spanheimer R. Effects of pioglitazone and metformin fixed-dose combination therapy on cardiovascular risk markers of inflammation and lipid profile compared with pioglitazone and metformin monotherapy in patients with type 2 diabetes. J Clin Hypertens (Greenwich). 2010 Dec;12(12):973-82. doi: 10.1111/j.1751-7176.2010.00389.x. Epub 2010 Nov 8.'}], 'seeAlsoLinks': [{'url': 'http://general.takedapharm.com/content/file/pi.pdf?applicationcode=ab2d7112-8eb3-465a-8fda-35018a9eafb0&fileTypeCode=ACTOPLUSMETPI', 'label': 'ACTOPLUS MET® Package Insert'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.', 'detailedDescription': 'Pioglitazone hydrochloride (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones, which act by reducing insulin resistance. Insulin resistance is a key feature of dysmetabolic syndrome and has been suggested to be the common pathophysiologic basis of both atherosclerosis and type 2 diabetes. Pioglitazone binds to peroxisome proliferator-activated receptors, an effect that is associated with altered transcription of genes capable of influencing carbohydrate and lipid metabolism.\n\nMetformin hydrochloride is an oral antihyperglycemic drug not chemically or pharmacologically related to thiazolidinediones. Metformin is a biguanide, which has been shown to be effective in improving glycemic control in diabetic patients. Metformin inhibits hepatic glucose production, most likely through an inhibition of gluconeogenesis, and its use is associated with an improvement in tissue sensitivity to insulin. In accordance with published algorithms for the use of combination therapy for the treatment of type 2 diabetes, physicians have traditionally combined metformin with other antidiabetic agents.\n\nThis study will determine the effect of a fixed-dose combination of metformin with pioglitazone, compared to metformin monotherapy and pioglitazone monotherapy.\n\nStudy participation is anticipated to be approximately 6.5 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Has type 2 diabetes.\n* Has received no treatment with antidiabetic medication in the 12 weeks prior to Screening, other than short-term use defined as less than or equal to 15 days.\n* A glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 10.0% at Screening.\n* Body mass index less than or equal to 45 kg/m2.\n* Has received counseling on lifestyle modification for type 2 diabetes, including diet and exercise.\n* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.\n* Stable condition as determined by a physician.\n\nExclusion Criteria\n\n* Type 1 diabetes.\n* Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV.\n* History of myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, or transient ischemic attack in the 6 months prior to Screening.\n* Male participant has a serum creatinine level greater than or equal to 1.5 mg per dL or female subject has a serum creatinine level greater than or equal to 1.4 mg per dL.\n* Has a triglyceride level greater than 500 mg per dL.\n* Male participant has a hemoglobin level less than 10.5 g per dL or female subject has a hemoglobin level less than 10.0 g per dL.\n* Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.\n* History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within 2 years prior to Screening.\n* Has been discontinued from a thiazolidinedione or metformin therapy due to lack of efficacy or clinical or laboratory signs of intolerance.\n* Previous history of cancer, other than basal cell or stage 1 squamous cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.\n* History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.\n* Any disease or condition at Screening or Randomization that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.\n* Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.\n* Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:\n\n * Antidiabetic medications other than study medication\n * Chronically used oral or parenteral glucocorticoids\n * Niacin greater than 200 mg per day, including niacin-containing products such as Advicor\n * Chronically used steroid-joint injections'}, 'identificationModule': {'nctId': 'NCT00727857', 'briefTitle': 'Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3b, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Pioglitazone HCl and Metformin HCl Fixed-Dose Combination Therapy Compared to Pioglitazone HCl Monotherapy and to Metformin HCl Monotherapy in the Treatment of Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '01-06-TL-OPIMET-008'}, 'secondaryIdInfos': [{'id': 'U1111-1114-0371', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pioglitazone 15 mg /Metformin 850 mg BID', 'interventionNames': ['Drug: Pioglitazone and metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone 15 mg BID', 'interventionNames': ['Drug: Pioglitazone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin 850 mg BID', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Pioglitazone and metformin', 'type': 'DRUG', 'otherNames': ['ACTOPLUS MET'], 'description': 'Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.', 'armGroupLabels': ['Pioglitazone 15 mg /Metformin 850 mg BID']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['ACTOS®', 'AD4833'], 'description': 'Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks.', 'armGroupLabels': ['Pioglitazone 15 mg BID']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Fortamet', 'Glucophage', 'Glucophage XR', 'Glumetza', 'Riomet'], 'description': 'Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.', 'armGroupLabels': ['Metformin 850 mg BID']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Haleyville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.22649, 'lon': -87.62141}}, {'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'city': 'Pell City', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.58621, 'lon': -86.28609}}, {'city': 'Phoenix', 'state': 'Arizona', 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