Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-26 @ 3:09 AM
Study NCT ID:
NCT02647320
Status:
COMPLETED
Last Update Posted:
2019-02-25
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'C000629701', 'term': 'firuglipel'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dsclinicaltrial@daiichisankyo.co.jp', 'phone': '+81-3-6225-1111(M-F 9-5 JST)', 'title': 'Daiichi Sankyo Contact for Clinical Trial Information', 'organization': 'Daiichi Sankyo'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Accidental fire at one site changed the baseline number of participants for the modified intent to treat (mITT) set. Because of this, baseline data were included in the outcome measures, rather than in the baseline module.'}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 7, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 2, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 11, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Sitagliptin 100 mg', 'description': 'Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 6, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Three placebo tablets and one placebo capsule in a once-daily oral dose', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 7, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablets and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.24', 'spread': '1.019', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.798', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '0.791', 'groupId': 'OG002'}, {'value': '-0.66', 'spread': '0.623', 'groupId': 'OG003'}, {'value': '-0.23', 'spread': '0.657', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.755', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.05', 'ciLowerLimit': '-0.211', 'ciUpperLimit': '0.309', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.512', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.11', 'ciLowerLimit': '-0.160', 'ciUpperLimit': '0.371', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.161', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.566', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.08', 'ciLowerLimit': '-0.312', 'ciUpperLimit': '0.151', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.140', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.002', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.43', 'ciLowerLimit': '-0.655', 'ciUpperLimit': '-0.197', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.139', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.', 'unitOfMeasure': 'percent of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Cholesterol (TC) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.6', 'spread': '11.95', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '22.30', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '12.58', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '14.34', 'groupId': 'OG003'}, {'value': '-1.7', 'spread': '13.57', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.144', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.6', 'ciLowerLimit': '-9.76', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.13', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.773', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.9', 'ciLowerLimit': '-6.14', 'ciUpperLimit': '4.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.16', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.963', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-4.73', 'ciUpperLimit': '4.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.79', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.258', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.1', 'ciLowerLimit': '-7.64', 'ciUpperLimit': '1.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.74', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.', 'unitOfMeasure': 'percent change in TC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'spread': '17.34', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '46.18', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '22.84', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '23.20', 'groupId': 'OG003'}, {'value': '0.9', 'spread': '20.12', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.228', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.7', 'ciLowerLimit': '-15.74', 'ciUpperLimit': '2.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.50', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.894', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7', 'ciLowerLimit': '-8.36', 'ciUpperLimit': '9.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.51', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.846', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.9', 'ciLowerLimit': '-8.97', 'ciUpperLimit': '7.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.86', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.409', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.9', 'ciLowerLimit': '-11.82', 'ciUpperLimit': '3.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.77', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'LDL-C is known as the "bad" cholesterol, so a lower score (negative change) means improvement.', 'unitOfMeasure': 'percent change in LDL-C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '11.48', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '10.18', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '11.59', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '13.17', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '11.41', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.576', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.5', 'ciLowerLimit': '-2.83', 'ciUpperLimit': '5.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.59', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.646', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.2', 'ciLowerLimit': '-5.53', 'ciUpperLimit': '3.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.62', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.902', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.3', 'ciLowerLimit': '-3.52', 'ciUpperLimit': '4.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.30', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.478', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.6', 'ciLowerLimit': '-5.35', 'ciUpperLimit': '2.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.27', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'HDL-C is known as the "good" cholesterol, so a higher score (positive change) means improvement.', 'unitOfMeasure': 'percent change in HCL-C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Non-HDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.9', 'spread': '14.89', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '31.68', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '16.68', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '19.10', 'groupId': 'OG003'}, {'value': '-2.5', 'spread': '17.02', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.072', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.6', 'ciLowerLimit': '-14.57', 'ciUpperLimit': '-0.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.22', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.794', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.1', 'ciLowerLimit': '-8.15', 'ciUpperLimit': '5.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.26', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.946', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-6.45', 'ciUpperLimit': '5.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.75', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.431', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.9', 'ciLowerLimit': '-8.99', 'ciUpperLimit': '3.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.68', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Non-HDL-C is the measure of "bad" cholesterol in the blood, including triglycerides and LDL-C, so a negative change means improvement. The equation for Non-HDL-C = LDL-C + (triglycerides/5).', 'unitOfMeasure': 'Percent change in Non-HDL-C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Triglycerides at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.4', 'spread': '22.35', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '78.27', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '27.71', 'groupId': 'OG002'}, {'value': '-7.0', 'spread': '27.90', 'groupId': 'OG003'}, {'value': '-3.0', 'spread': '27.76', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.228', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-10.3', 'ciLowerLimit': '-24.43', 'ciUpperLimit': '3.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.54', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.951', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.5', 'ciLowerLimit': '-13.70', 'ciUpperLimit': '14.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.62', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.852', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.4', 'ciLowerLimit': '-13.96', 'ciUpperLimit': '11.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.59', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.608', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.8', 'ciLowerLimit': '-16.13', 'ciUpperLimit': '8.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.45', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease. Since Type 2 diabetics tend to have high triglycerides, a negative change means improvement.', 'unitOfMeasure': 'percent change in triglycerides', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.32', 'spread': '71.235', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '67.661', 'groupId': 'OG001'}, {'value': '-6.32', 'spread': '83.597', 'groupId': 'OG002'}, {'value': '-41.61', 'spread': '73.971', 'groupId': 'OG003'}, {'value': '-3.97', 'spread': '87.625', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.728', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.32', 'ciLowerLimit': '-19.932', 'ciUpperLimit': '30.566', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.289', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.837', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.27', 'ciLowerLimit': '-29.446', 'ciUpperLimit': '22.914', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.853', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.791', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.65', 'ciLowerLimit': '-26.352', 'ciUpperLimit': '19.051', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.747', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.003', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-40.03', 'ciLowerLimit': '-62.283', 'ciUpperLimit': '-17.787', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.472', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.', 'unitOfMeasure': '(mg/dL)*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT with a measurement at baseline and Week 4'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.77', 'spread': '96.472', 'groupId': 'OG000'}, {'value': '13.81', 'spread': '67.025', 'groupId': 'OG001'}, {'value': '-5.51', 'spread': '104.992', 'groupId': 'OG002'}, {'value': '-53.40', 'spread': '74.803', 'groupId': 'OG003'}, {'value': '-24.16', 'spread': '101.016', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.830', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.39', 'ciLowerLimit': '-29.312', 'ciUpperLimit': '38.087', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.396', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.235', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '24.25', 'ciLowerLimit': '-9.354', 'ciUpperLimit': '57.848', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.335', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.331', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '17.25', 'ciLowerLimit': '-12.030', 'ciUpperLimit': '46.529', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.720', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.091', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-29.51', 'ciLowerLimit': '-58.254', 'ciUpperLimit': '-0.775', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.393', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.', 'unitOfMeasure': '(mg/dL)*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT with a measurement at baseline and Week 12'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.92', 'spread': '41.260', 'groupId': 'OG000'}, {'value': '-7.35', 'spread': '39.645', 'groupId': 'OG001'}, {'value': '-3.47', 'spread': '54.258', 'groupId': 'OG002'}, {'value': '-28.44', 'spread': '45.327', 'groupId': 'OG003'}, {'value': '-0.35', 'spread': '41.885', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.873', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.49', 'ciLowerLimit': '-13.835', 'ciUpperLimit': '16.815', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.280', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.395', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-8.09', 'ciLowerLimit': '-23.790', 'ciUpperLimit': '7.604', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.505', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.761', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.53', 'ciLowerLimit': '-16.247', 'ciUpperLimit': '11.185', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.306', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-27.73', 'ciLowerLimit': '-41.220', 'ciUpperLimit': '-14.236', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.170', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT with a measurement at baseline and Week 4'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cmax of PG in Response to MMTT at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.93', 'spread': '47.530', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '53.045', 'groupId': 'OG001'}, {'value': '-4.43', 'spread': '60.957', 'groupId': 'OG002'}, {'value': '-28.29', 'spread': '42.184', 'groupId': 'OG003'}, {'value': '1.11', 'spread': '58.731', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.527', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.61', 'ciLowerLimit': '-27.441', 'ciUpperLimit': '12.221', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.001', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.532', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.39', 'ciLowerLimit': '-26.927', 'ciUpperLimit': '12.138', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.532', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.672', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.41', 'ciLowerLimit': '-21.635', 'ciUpperLimit': '12.807', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.421', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.002', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-31.58', 'ciLowerLimit': '-48.482', 'ciUpperLimit': '-14.676', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.229', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT with a measurement at baseline and Week 12'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '25.98', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '25.24', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '31.52', 'groupId': 'OG002'}, {'value': '-16.2', 'spread': '26.11', 'groupId': 'OG003'}, {'value': '10.7', 'spread': '32.38', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.298', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.2', 'ciLowerLimit': '-15.90', 'ciUpperLimit': '3.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.90', 'groupDescription': 'Difference in change at week 2', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.008', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-16.3', 'ciLowerLimit': '-26.37', 'ciUpperLimit': '-6.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.09', 'groupDescription': 'Difference in change at week 2', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.074', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-9.5', 'ciLowerLimit': '-18.31', 'ciUpperLimit': '-0.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.32', 'groupDescription': 'Difference in change at week 2', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-27.2', 'ciLowerLimit': '-35.96', 'ciUpperLimit': '-18.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.32', 'groupDescription': 'Difference in change at week 2', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2', 'description': 'Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT with a measurement at baseline and Week 2'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '18.71', 'groupId': 'OG000'}, {'value': '-12.7', 'spread': '30.82', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '35.17', 'groupId': 'OG002'}, {'value': '-11.1', 'spread': '31.81', 'groupId': 'OG003'}, {'value': '2.4', 'spread': '32.01', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.840', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.2', 'ciLowerLimit': '-11.04', 'ciUpperLimit': '8.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.96', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.050', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-11.9', 'ciLowerLimit': '-21.94', 'ciUpperLimit': '-1.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.06', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.227', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.4', 'ciLowerLimit': '-15.21', 'ciUpperLimit': '2.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.31', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.13', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-13.1', 'ciLowerLimit': '-21.83', 'ciUpperLimit': '-4.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.27', 'groupDescription': 'Difference in change at week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT with a measurement at baseline and Week 4'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '27.57', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '27.90', 'groupId': 'OG001'}, {'value': '-7.1', 'spread': '37.51', 'groupId': 'OG002'}, {'value': '-16.6', 'spread': '32.96', 'groupId': 'OG003'}, {'value': '-1.0', 'spread': '31.63', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.642', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.1', 'ciLowerLimit': '-7.77', 'ciUpperLimit': '13.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.55', 'groupDescription': 'Difference in change at week 8', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.512', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.4', 'ciLowerLimit': '-15.52', 'ciUpperLimit': '6.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.72', 'groupDescription': 'Difference in change at week 8', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.486', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.1', 'ciLowerLimit': '-13.66', 'ciUpperLimit': '5.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.81', 'groupDescription': 'Difference in change at week 8', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.004', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-16.7', 'ciLowerLimit': '-26.31', 'ciUpperLimit': '-7.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.80', 'groupDescription': 'Difference in change at week 8', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT with a measurement at baseline and Week 8'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '25.67', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '34.89', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '35.27', 'groupId': 'OG002'}, {'value': '-5.7', 'spread': '46.29', 'groupId': 'OG003'}, {'value': '8.1', 'spread': '32.72', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.285', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-8.7', 'ciLowerLimit': '-22.09', 'ciUpperLimit': '4.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.11', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.020', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-18.6', 'ciLowerLimit': '-31.73', 'ciUpperLimit': '-5.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.94', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.067', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-13.0', 'ciLowerLimit': '-24.60', 'ciUpperLimit': '-1.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.03', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}, {'pValue': '.012', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-17.4', 'ciLowerLimit': '-28.76', 'ciUpperLimit': '-6.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.88', 'groupDescription': 'Difference in change at week 12', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT with a measurement at baseline and Week 12'}, {'type': 'SECONDARY', 'title': 'Count of Participants With HbA1c Less Than 7.0% at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet and placebo'}, {'id': 'OG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets and placebo'}, {'id': 'OG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and placebo'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'One sitagliptin 100 mg over-capsule and placebo'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo tablets and placebo capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'HbA1C less than 7% is the success goal for many Type 2 diabetics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose'}, {'id': 'FG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose'}, {'id': 'FG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose'}, {'id': 'FG003', 'title': 'Sitagliptin 100 mg', 'description': 'Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Three placebo tablets and one placebo capsule in a once-daily oral dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '68'}, {'groupId': 'FG004', 'numSubjects': '69'}]}, {'type': 'Inadvertently Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '68'}, {'groupId': 'FG004', 'numSubjects': '69'}]}, {'type': 'Modified Intent-to-Treat Set (mITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '62'}, {'groupId': 'FG004', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '58'}, {'groupId': 'FG004', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Persistent hyperglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Reason not provided', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Develop anemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Disposition Missing Due to Fire at Site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'A total of 654 subjects were recruited at multiple sites in the United States and Canada.', 'preAssignmentDetails': 'A total of 654 subjects were screened and 297 subjects passed the run-in screening period and were randomized. One subject failed screening but was randomized in error.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '298', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose'}, {'id': 'BG001', 'title': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose'}, {'id': 'BG002', 'title': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose'}, {'id': 'BG003', 'title': 'Sitagliptin 100 mg', 'description': 'Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Three placebo tablets and one placebo capsule in a once-daily oral dose'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '298', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '56.4', 'spread': '9.30', 'groupId': 'BG000'}, {'value': '57.0', 'spread': '8.95', 'groupId': 'BG001'}, {'value': '57.0', 'spread': '9.41', 'groupId': 'BG002'}, {'value': '57.4', 'spread': '7.77', 'groupId': 'BG003'}, {'value': '55.6', 'spread': '7.72', 'groupId': 'BG004'}, {'value': '56.7', 'spread': '8.56', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '298', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '140', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '158', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '298', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '222', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '298', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '298', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '251', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '1. Glycated Hemoglobin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '263', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7.94', 'spread': '0.939', 'groupId': 'BG000'}, {'value': '8.09', 'spread': '0.910', 'groupId': 'BG001'}, {'value': '7.99', 'spread': '0.900', 'groupId': 'BG002'}, {'value': '7.78', 'spread': '0.790', 'groupId': 'BG003'}, {'value': '7.92', 'spread': '0.699', 'groupId': 'BG004'}, {'value': '7.93', 'spread': '0.852', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial.', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.'}, {'title': '2. Total Cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '263', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '177.1', 'spread': '36.72', 'groupId': 'BG000'}, {'value': '180.3', 'spread': '32.21', 'groupId': 'BG001'}, {'value': '178.0', 'spread': '37.38', 'groupId': 'BG002'}, {'value': '172.6', 'spread': '55.25', 'groupId': 'BG003'}, {'value': '182.8', 'spread': '43.11', 'groupId': 'BG004'}, {'value': '178.1', 'spread': '41.70', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.'}, {'title': '3. Low Density Lipoprotein-C', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '263', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '96.6', 'spread': '33.58', 'groupId': 'BG000'}, {'value': '96.9', 'spread': '30.53', 'groupId': 'BG001'}, {'value': '96.6', 'spread': '32.84', 'groupId': 'BG002'}, {'value': '95.1', 'spread': '37.93', 'groupId': 'BG003'}, {'value': '99.8', 'spread': '37.14', 'groupId': 'BG004'}, {'value': '97.0', 'spread': '34.51', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'LDL-C is known as the "bad" cholesterol.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.'}, {'title': '4. High Density Lipoprotein-C', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '263', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '49.5', 'spread': '12.80', 'groupId': 'BG000'}, {'value': '49.3', 'spread': '13.20', 'groupId': 'BG001'}, {'value': '46.4', 'spread': '11.77', 'groupId': 'BG002'}, {'value': '44.3', 'spread': '12.17', 'groupId': 'BG003'}, {'value': '46.7', 'spread': '10.93', 'groupId': 'BG004'}, {'value': '46.87', 'spread': '12.19', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'HDL-C is known as the "good" cholesterol.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.'}, {'title': '5. Non-High Density Lipoprotein-C', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '263', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '127.6', 'spread': '38.13', 'groupId': 'BG000'}, {'value': '131.0', 'spread': '32.54', 'groupId': 'BG001'}, {'value': '131.6', 'spread': '35.93', 'groupId': 'BG002'}, {'value': '128.4', 'spread': '44.46', 'groupId': 'BG003'}, {'value': '136.1', 'spread': '40.69', 'groupId': 'BG004'}, {'value': '131.21', 'spread': '38.56', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Non-HDL-C is the measure of "bad" cholesterol in the blood, including triglycerides and LDL-C.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.'}, {'title': '6. Triglycerides', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '263', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '165.3', 'spread': '114.5', 'groupId': 'BG000'}, {'value': '174.9', 'spread': '95.55', 'groupId': 'BG001'}, {'value': '179.6', 'spread': '83.39', 'groupId': 'BG002'}, {'value': '169.8', 'spread': '84.90', 'groupId': 'BG003'}, {'value': '184.2', 'spread': '91.02', 'groupId': 'BG004'}, {'value': '175.5', 'spread': '94.54', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.'}], 'populationDescription': 'All participants randomized'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-28', 'size': 846194, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-01-26T16:41', 'hasProtocol': True}]}}, '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': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2016-01-04', 'resultsFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-27', 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Cholesterol (TC) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.'}, {'measure': 'Change From Baseline in LDL-C at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'LDL-C is known as the "bad" cholesterol, so a lower score (negative change) means improvement.'}, {'measure': 'Change From Baseline in HDL-C at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'HDL-C is known as the "good" cholesterol, so a higher score (positive change) means improvement.'}, {'measure': 'Change From Baseline in Non-HDL-C at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Non-HDL-C is the measure of "bad" cholesterol in the blood, including triglycerides and LDL-C, so a negative change means improvement. The equation for Non-HDL-C = LDL-C + (triglycerides/5).'}, {'measure': 'Change From Baseline in Triglycerides at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease. Since Type 2 diabetics tend to have high triglycerides, a negative change means improvement.'}, {'measure': 'Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.'}, {'measure': 'Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.'}, {'measure': 'Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.'}, {'measure': 'Change From Baseline in Cmax of PG in Response to MMTT at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2', 'timeFrame': 'Baseline, Week 2', 'description': 'Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.'}, {'measure': 'Count of Participants With HbA1c Less Than 7.0% at Week 12', 'timeFrame': 'Week 12', 'description': 'HbA1C less than 7% is the success goal for many Type 2 diabetics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 2 diabetes mellitus', 'interventional', 'double blind', 'phase 2'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able to provide written informed consent and adhere to the study visit schedule and treatment\n* Diagnosed with Type 2 diabetes mellitus as defined in the American Diabetes Association Standards of Medical Care in Diabetes 2015\n* Male or female ≥ 18 and ≤ 70 years of age\n* Screening fasting C-peptide \\> 0.5 ng/mL\n* Women of child bearing potential (WOCBP) must be willing to use double-barrier contraception for the entire study\n* WOCBP must have a negative pregnancy test (human chorionic gonadotropin, beta subunit \\[βhCG\\]) before entering the Lead-in Period\n* Body mass index ≥ 25 kg/m2 and ≤ 45 kg/m2 at the Screening Visit\n* On stable (≥ 8 weeks) metformin monotherapy ≥ 1000 mg/day\n* Screening HbA1c ≥ 7.0% and ≤ 10%\n* Taking ≥ 80% and ≤ 120% of both dispensed DS-8500a placebo tablets and sitagliptin placebo capsules during the Lead-in Period\n\nExclusion Criteria:\n\n* History of type 1 diabetes and/or history of ketoacidosis\n* History of insulin use for \\> 2 weeks within 2 months prior to the Screening Visit\n* Two or more readings of fasting Self-monitoring of Blood Glucose (SMBG) \\> 240 mg/dL or worsening symptoms of hyperglycemia with one SMBG level of \\> 240 mg/dL during the second week of Lead-in Period, confirmed by laboratory measurement\n* Screening hemoglobin \\<12 g/dL for males and \\<11 g/dL for females\n* Blood donation within 2 months prior to the Screening Visit or plans to donate blood or blood products during the study\n* Subjects after bariatric surgery or any gastric bypass\n* Screening thyroid stimulating hormone (TSH) levels not within normal range (based on reference laboratory values )\n* Screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \\> 2.0 x upper limit of normal (ULN), and/or total bilirubin \\> 1.5 x ULN. If a subject has total bilirubin \\> 1.5 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert's syndrome may be enrolled\n* Screening Serum creatinine ≥ 1.5 mg/dL for males and ≥ 1.4 mg/dL for females, or creatinine clearance (CrCl) \\< 50 mL/min for both males and females\n* Screening Creatine kinase (CK) \\> 3.0 × ULN\n* History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, peripheral arterial event or any revascularization procedure during the 6 months prior to the Screening Visit or planned vascular procedures or surgery during study period\n* History of congestive heart failure (CHF)\n* Exclusionary concomitant medications:\n\n a. Eight weeks prior to screening and throughout the duration of the study:\n* Any diabetes medication other than metformin; any prescription or over the counter medication for weight-loss.\n* Systemic corticosteroids (including nasal and inhaled), with the exception of use of topical and ophthalmic corticosteroids.\n* Rosuvastatin \\> 20 mg daily. b. During treatment periods, additional medications will be prohibited based on potential drug-drug interaction (DDI) (see Section 5.6)\n* Subjects with anticipated interruption in metformin or study drug use during the course of the clinical trial (e.g., due to an imaging procedure involving iodinated contrast media)\n* Subjects in whom treatment with sitagliptin 100 mg is contraindicated ( e.g., known hypersensitivity or intolerance to sitagliptin) or may not be medically advisable (e.g., history of pancreatitis)\n* Abuse of or dependence on prescription medications, illicit drugs, or alcohol within the last 1 year\n* Any history of a malignancy other than basal cell carcinoma within the past 5 years\n* Pregnancy or breast-feeding, or intent to become pregnant during the study period\n* Known (or evidence of) infection with human immunodeficiency virus\n* Any condition, laboratory abnormality, or concomitant therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation not in the subject's best interest\n* Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents\n* A direct or familial relationship with the Sponsor, Investigator, or site personnel affiliated with the study"}, 'identificationModule': {'nctId': 'NCT02647320', 'briefTitle': '12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled With Active Comparator, 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin', 'orgStudyIdInfo': {'id': 'DS8500-A-U202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DS-8500a 25mg', 'description': 'One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose', 'interventionNames': ['Drug: DS-8500a 25mg', 'Drug: Placebo Tablet', 'Drug: Placebo Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'DS-8500a 50 mg', 'description': 'Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose', 'interventionNames': ['Drug: DS-8500a 25mg', 'Drug: Placebo Tablet', 'Drug: Placebo Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'DS-8500a 75 mg', 'description': 'Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose', 'interventionNames': ['Drug: DS-8500a 25mg', 'Drug: Placebo Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Three placebo tablets and one placebo capsule in a once-daily oral dose', 'interventionNames': ['Drug: Placebo Tablet', 'Drug: Placebo Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin 100 mg', 'description': 'Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose', 'interventionNames': ['Drug: Sitagliptin 100 mg', 'Drug: Placebo Tablet']}], 'interventions': [{'name': 'Sitagliptin 100 mg', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration', 'armGroupLabels': ['Sitagliptin 100 mg']}, {'name': 'DS-8500a 25mg', 'type': 'DRUG', 'otherNames': ['Investigational product'], 'description': 'DS-8500a 25mg tablet for oral administration', 'armGroupLabels': ['DS-8500a 25mg', 'DS-8500a 50 mg', 'DS-8500a 75 mg']}, {'name': 'Placebo Tablet', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo matching DS-8500a tablet for oral administration', 'armGroupLabels': ['DS-8500a 25mg', 'DS-8500a 50 mg', 'Placebo', 'Sitagliptin 100 mg']}, {'name': 'Placebo Capsule', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo matching sitagliptin over-capsule for oral administration', 'armGroupLabels': ['DS-8500a 25mg', 'DS-8500a 50 mg', 'DS-8500a 75 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85340', 'city': 'Litchfield Park', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.49337, 'lon': -112.35794}}, {'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '95670', 'city': 'Gold River', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.62629, 'lon': -121.24662}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80920', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80227', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33026', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '47725', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46131', 'city': 'Franklin', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.48061, 'lon': -86.05499}}, {'zip': '46140', 'city': 'Greenfield', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.78504, 'lon': -85.76942}}, {'zip': '51503', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '63090', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '28117', 'city': 'Mooresville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.58486, 'lon': -80.81007}}, {'zip': '28655', 'city': 'Morgantown', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.12208, 'lon': -79.42891}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77036', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75024', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78228', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84102', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': '22015', 'city': 'Burke', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.79345, 'lon': -77.27165}}, {'zip': 'V8V 4A1', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'L6T 0G1', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'N5W 6A2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3Y 5GB', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M9V 4B4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9W 4L6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J7J 2K8', 'city': 'Mirabel', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.65008, 'lon': -74.08251}}, {'zip': 'H4N 2W2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1W 4R4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 1Z1', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Clinical Study Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}