Viewing Study NCT01475461

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Ignite Creation Date: 2025-12-24 @ 12:55 PM
Ignite Modification Date: 2025-12-30 @ 6:33 AM
Study NCT ID: NCT01475461
Status: COMPLETED
Last Update Posted: 2017-01-31
First Post: 2011-09-15
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'C000598526', 'term': 'N,N-dimethyl-5-((2-methyl-6-((5-methylpyrazin-2-yl)carbamoyl)benzofuran-4-yl)oxy)pyrimidine-2-carboxamide'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], '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': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. AEs were also collected during the course of run-in period (metformin background therapy).', 'eventGroups': [{'id': 'EG000', 'title': 'Metformin 500 mg', 'description': 'Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.', 'otherNumAtRisk': 376, 'otherNumAffected': 37, 'seriousNumAtRisk': 376, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.', 'otherNumAtRisk': 57, 'otherNumAffected': 19, 'seriousNumAtRisk': 57, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.', 'otherNumAtRisk': 57, 'otherNumAffected': 19, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.', 'otherNumAtRisk': 54, 'otherNumAffected': 19, 'seriousNumAtRisk': 54, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.', 'otherNumAtRisk': 56, 'otherNumAffected': 16, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.', 'otherNumAtRisk': 56, 'otherNumAffected': 24, 'seriousNumAtRisk': 56, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Sitagliptin 100 mg', 'description': 'Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.', 'otherNumAtRisk': 55, 'otherNumAffected': 18, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Type IIb hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Type IV hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asymptomatic bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, 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and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=50,55,48,55,53,53)', 'categories': [{'measurements': [{'value': '8.01', 'spread': '1.099', 'groupId': 'OG000'}, {'value': '8.00', 'spread': '1.031', 'groupId': 'OG001'}, {'value': '7.80', 'spread': '0.965', 'groupId': 'OG002'}, {'value': '8.15', 'spread': '1.002', 'groupId': 'OG003'}, {'value': '8.31', 'spread': '1.043', 'groupId': 'OG004'}, {'value': '7.89', 'spread': '1.022', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 12 (n=46,52,45,52,50,53)', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.821', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.793', 'groupId': 'OG001'}, {'value': '-0.53', 'spread': '0.919', 'groupId': 'OG002'}, {'value': '-0.59', 'spread': '0.988', 'groupId': 'OG003'}, {'value': '-0.80', 'spread': '0.955', 'groupId': 'OG004'}, {'value': '-0.79', 'spread': '0.859', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.5206', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.01', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.23', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'Week 12: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made for multiple comparisons among treatment groups.', 'testedNonInferiority': False}, {'pValue': '0.1645', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.17', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.05', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.178', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made for multiple comparisons among treatment groups.', 'testedNonInferiority': False}, {'pValue': '0.1592', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.17', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.05', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made for multiple comparisons among treatment groups.', 'testedNonInferiority': False}, {'pValue': '0.0049', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.45', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.23', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.174', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0068', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.43', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '-0.21', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.173', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 12', 'description': 'HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (\\<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'title': 'Change at Week 4 (n= 50, 55, 48, 55, 53, 53)', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.568', 'groupId': 'OG001'}, {'value': '-0.32', 'spread': '0.520', 'groupId': 'OG002'}, {'value': '-0.35', 'spread': '0.601', 'groupId': 'OG003'}, {'value': '-0.50', 'spread': '0.470', 'groupId': 'OG004'}, {'value': '-0.52', 'spread': '0.503', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 8 (n=48, 53, 45, 52, 50, 51)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.664', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '0.781', 'groupId': 'OG001'}, {'value': '-0.46', 'spread': '0.803', 'groupId': 'OG002'}, {'value': '-0.50', 'spread': '0.848', 'groupId': 'OG003'}, {'value': '-0.86', 'spread': '0.726', 'groupId': 'OG004'}, {'value': '-0.77', 'spread': '0.699', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.3434', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.04', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.09', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.097', 'groupDescription': 'Week 4: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0892', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.14', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '-0.01', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.101', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0826', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.14', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '-0.01', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.097', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0031', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.27', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '-0.15', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.098', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.33', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '-0.20', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.098', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.00', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.19', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.144', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1873', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.13', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.06', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2120', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.12', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.07', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.145', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.54', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '-0.35', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.146', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.42', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '-0.23', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.146', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(Day 1), Week 2, 4, 8', 'description': 'HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as \\<6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS: All randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was summarized for this measure and 'n' signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=56, 56, 52, 56, 55, 55)', 'categories': [{'measurements': [{'value': '168.3', 'spread': '42.99', 'groupId': 'OG000'}, {'value': '159.8', 'spread': '40.43', 'groupId': 'OG001'}, {'value': '155.1', 'spread': '37.74', 'groupId': 'OG002'}, {'value': '166.1', 'spread': '42.56', 'groupId': 'OG003'}, {'value': '164.8', 'spread': '41.14', 'groupId': 'OG004'}, {'value': '160.7', 'spread': '35.87', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 2 (n=54, 56, 50, 56, 54, 55)', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '26.22', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '26.21', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '19.67', 'groupId': 'OG002'}, {'value': '-6.8', 'spread': '32.84', 'groupId': 'OG003'}, {'value': '-10.8', 'spread': '25.73', 'groupId': 'OG004'}, {'value': '-13.6', 'spread': '23.75', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 4 (n=52, 56, 51, 55, 54, 53)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '31.25', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '23.21', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '21.29', 'groupId': 'OG002'}, {'value': '-8.3', 'spread': '34.02', 'groupId': 'OG003'}, {'value': '-9.6', 'spread': '29.30', 'groupId': 'OG004'}, {'value': '-19.3', 'spread': '26.33', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 8 (n=50, 54, 47, 52, 51, 52)', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '37.03', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '26.83', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '27.49', 'groupId': 'OG002'}, {'value': '-15.2', 'spread': '32.29', 'groupId': 'OG003'}, {'value': '-6.5', 'spread': '29.50', 'groupId': 'OG004'}, {'value': '-15.4', 'spread': '25.98', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 12 (n=48, 53, 47, 52, 51, 53)', 'categories': [{'measurements': [{'value': '-7.5', 'spread': '31.21', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '28.58', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '31.62', 'groupId': 'OG002'}, {'value': '-10.8', 'spread': '37.51', 'groupId': 'OG003'}, {'value': '3.5', 'spread': '41.74', 'groupId': 'OG004'}, {'value': '-12.9', 'spread': '31.97', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 14 (n=45, 53, 46, 52, 51, 53)', 'categories': [{'measurements': [{'value': '-5.9', 'spread': '33.18', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '28.43', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '32.62', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '34.37', 'groupId': 'OG003'}, {'value': '10.2', 'spread': '38.62', 'groupId': 'OG004'}, {'value': '-2.6', 'spread': '36.41', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.7240', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.87', 'ciLowerLimit': '-3.32', 'ciUpperLimit': '9.07', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.823', 'groupDescription': 'Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3608', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.77', 'ciLowerLimit': '-8.13', 'ciUpperLimit': '4.59', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.952', 'groupDescription': 'Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2511', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.24', 'ciLowerLimit': '-9.42', 'ciUpperLimit': '2.95', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.816', 'groupDescription': 'Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0673', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-7.28', 'ciLowerLimit': '-13.51', 'ciUpperLimit': '-1.05', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.851', 'groupDescription': 'Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0106', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-11.22', 'ciLowerLimit': '-17.44', 'ciUpperLimit': '-5.00', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.843', 'groupDescription': 'Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4127', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.13', 'ciLowerLimit': '-7.73', 'ciUpperLimit': '5.47', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.138', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3604', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.88', 'ciLowerLimit': '-8.64', 'ciUpperLimit': '4.87', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.261', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0770', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-7.35', 'ciLowerLimit': '-13.96', 'ciUpperLimit': '-0.74', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.147', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0451', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-8.79', 'ciLowerLimit': '-15.43', 'ciUpperLimit': '-2.15', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.171', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-19.90', 'ciLowerLimit': '-26.57', 'ciUpperLimit': '-13.23', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.191', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5783', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.11', 'ciLowerLimit': '-6.08', 'ciUpperLimit': '8.30', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.599', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3604', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.07', 'ciLowerLimit': '-9.50', 'ciUpperLimit': '5.36', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.785', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0161', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-12.12', 'ciLowerLimit': '-19.36', 'ciUpperLimit': '-4.88', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.636', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2185', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.41', 'ciLowerLimit': '-11.68', 'ciUpperLimit': '2.87', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.663', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0034', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-15.41', 'ciLowerLimit': '-22.67', 'ciUpperLimit': '-8.16', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.649', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5727', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.17', 'ciLowerLimit': '-7.03', 'ciUpperLimit': '9.37', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.387', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4961', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.06', 'ciLowerLimit': '-8.51', 'ciUpperLimit': '8.38', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.578', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2616', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.10', 'ciLowerLimit': '-12.33', 'ciUpperLimit': '4.14', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.411', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9197', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '9.06', 'ciLowerLimit': '0.79', 'ciUpperLimit': '17.34', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.441', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0860', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-8.76', 'ciLowerLimit': '-16.98', 'ciUpperLimit': '-0.54', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.398', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.22', 'ciLowerLimit': '-8.10', 'ciUpperLimit': '8.53', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.476', 'groupDescription': 'Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6560', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.68', 'ciLowerLimit': '-5.89', 'ciUpperLimit': '11.26', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.676', 'groupDescription': 'Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8285', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.17', 'ciLowerLimit': '-2.17', 'ciUpperLimit': '14.52', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.496', 'groupDescription': 'Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9925', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '15.98', 'ciLowerLimit': '7.59', 'ciUpperLimit': '24.36', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.527', 'groupDescription': 'Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6010', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.66', 'ciLowerLimit': '-6.67', 'ciUpperLimit': '10.00', 'pValueComment': 'p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.487', 'groupDescription': 'Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 1, 2, 4, 8, 12, 14', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS: All randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was summarized for this measure and 'n' signifies participants who were evaluable at given time points for each group. Data for Week 1 had not been reported because as per protocol it was not intended to be collected."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'title': '<6.5 percent', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}, {'value': '19.1', 'groupId': 'OG002'}, {'value': '15.4', 'groupId': 'OG003'}, {'value': '17.6', 'groupId': 'OG004'}, {'value': '32.1', 'groupId': 'OG005'}]}]}, {'title': '<7 percent', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000'}, {'value': '26.4', 'groupId': 'OG001'}, {'value': '42.6', 'groupId': 'OG002'}, {'value': '30.8', 'groupId': 'OG003'}, {'value': '39.2', 'groupId': 'OG004'}, {'value': '56.6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as \\<6.5 percent by the study-specific central laboratory used and data are presented in categories of \\<6.5 percent and \\<7 percent.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS: All randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was summarized for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'title': 'PR interval: Percent change of >=25/50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'QRS interval: Percent change of >=50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'QTcF interval: Change of >=30 to <60 msec', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'QTcF interval: Change of >=60 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 14', 'description': "Criteria for increase from baseline data: PR interval (percent change of greater than or equal to \\[\\>=\\] 25/50% \\[if baseline\\>200 then percent change of \\>25% counts; if baseline \\<=200 then percent change of \\>50% counts\\]; QRS complex (percent change of \\>=50%); QT Fridericia's correction (QTcF) interval (change of \\>=30 to \\<60 millisecond \\[msec\\], and change of \\>=60 msec).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Increase/Decrease From Baseline Vital Signs Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'title': 'Increase in systolic BP (>=30 mmHg)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Increase in diastolic BP (>=20 mmHg)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Decrease in systolic BP (>=30 mmHg)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Decrease in diastolic BP (>=20 mmHg)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 14', 'description': "Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of \\>=30 millimeter of mercury (mmHg); sitting diastolic BP of \\>=20 mmHg and pulse rate was based on investigator's discretion.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin 500 mg', 'description': 'Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG006', 'title': 'Sitagliptin 100 mg', 'description': 'Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to 14 days after last dose (up to 101 days)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin 500 mg', 'description': 'Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG006', 'title': 'Sitagliptin 100 mg', 'description': 'Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 14', 'description': 'A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =\\< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =\\<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =\\<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =\\<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycemic Events (HAE) Episodes Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '56', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin 500 mg', 'description': 'Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG006', 'title': 'Sitagliptin 100 mg', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) up to Week 14', 'description': 'A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported', 'unitOfMeasure': 'events per participant', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'Sitagliptin 100 mg', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=55, 55, 50, 56, 54, 55)', 'categories': [{'measurements': [{'value': '86.446', 'spread': '19.1859', 'groupId': 'OG000'}, {'value': '87.865', 'spread': '23.7732', 'groupId': 'OG001'}, {'value': '88.371', 'spread': '17.3923', 'groupId': 'OG002'}, {'value': '88.066', 'spread': '20.3446', 'groupId': 'OG003'}, {'value': '91.239', 'spread': '21.2731', 'groupId': 'OG004'}, {'value': '87.025', 'spread': '21.2567', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 2 (n=54, 55, 49, 56, 53, 55)', 'categories': [{'measurements': [{'value': '-0.239', 'spread': '0.7264', 'groupId': 'OG000'}, {'value': '0.435', 'spread': '5.2348', 'groupId': 'OG001'}, {'value': '-0.052', 'spread': '1.0570', 'groupId': 'OG002'}, {'value': '-0.283', 'spread': '1.0520', 'groupId': 'OG003'}, {'value': '-0.053', 'spread': '0.9010', 'groupId': 'OG004'}, {'value': '-0.384', 'spread': '1.1041', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 4 (n=51, 55, 49, 55, 53, 53)', 'categories': [{'measurements': [{'value': '-0.704', 'spread': '1.5651', 'groupId': 'OG000'}, {'value': '0.214', 'spread': '5.1426', 'groupId': 'OG001'}, {'value': '-0.192', 'spread': '1.4649', 'groupId': 'OG002'}, {'value': '-0.203', 'spread': '1.7609', 'groupId': 'OG003'}, {'value': '-0.374', 'spread': '1.2083', 'groupId': 'OG004'}, {'value': '-0.353', 'spread': '1.1598', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 8 (n=49, 53, 45, 52, 50, 52)', 'categories': [{'measurements': [{'value': '-0.823', 'spread': '1.6750', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '5.0869', 'groupId': 'OG001'}, {'value': '-0.510', 'spread': '1.7467', 'groupId': 'OG002'}, {'value': '-0.270', 'spread': '1.6559', 'groupId': 'OG003'}, {'value': '-0.475', 'spread': '1.4374', 'groupId': 'OG004'}, {'value': '-0.702', 'spread': '1.6095', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 12 (n=47, 52, 45, 52, 50, 53)', 'categories': [{'measurements': [{'value': '-0.804', 'spread': '2.0119', 'groupId': 'OG000'}, {'value': '-0.142', 'spread': '4.8928', 'groupId': 'OG001'}, {'value': '-0.455', 'spread': '1.9213', 'groupId': 'OG002'}, {'value': '-0.352', 'spread': '1.8121', 'groupId': 'OG003'}, {'value': '-0.623', 'spread': '1.9647', 'groupId': 'OG004'}, {'value': '-0.917', 'spread': '1.9591', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 14 (n=44, 52, 44, 52, 50, 53)', 'categories': [{'measurements': [{'value': '-0.588', 'spread': '2.0994', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.6634', 'groupId': 'OG001'}, {'value': '-0.613', 'spread': '0.3149', 'groupId': 'OG002'}, {'value': '-0.492', 'spread': '0.2823', 'groupId': 'OG003'}, {'value': '-0.916', 'spread': '0.3743', 'groupId': 'OG004'}, {'value': '-1.172', 'spread': '0.2850', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0913', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.76', 'ciLowerLimit': '0.18', 'ciUpperLimit': '1.34', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.449', 'groupDescription': 'Week 2: Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5236', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.29', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.89', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.461', 'groupDescription': 'Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9244', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.04', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.62', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.447', 'groupDescription': 'Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5066', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.30', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.88', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.452', 'groupDescription': 'Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8947', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.06', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.52', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.449', 'groupDescription': 'Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.91', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.52', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.478', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.51', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '1.14', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.490', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3165', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.48', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '1.09', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.476', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5191', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.31', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.93', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.481', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5107', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.32', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.93', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.479', 'groupDescription': 'Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.79', 'ciLowerLimit': '0.17', 'ciUpperLimit': '1.42', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.488', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5341', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.31', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.96', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.502', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2782', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.53', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '1.15', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.487', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5331', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.31', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.94', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.492', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9070', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.06', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.68', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.489', 'groupDescription': 'Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1757', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.69', 'ciLowerLimit': '0.04', 'ciUpperLimit': '1.35', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.512', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4083', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.44', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '1.11', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.527', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3150', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.51', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '1.17', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.511', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6631', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.23', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.89', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.516', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8694', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.08', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.57', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.512', 'groupDescription': 'Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.70', 'ciLowerLimit': '0.00', 'ciUpperLimit': '1.40', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.545', 'groupDescription': 'Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7137', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.21', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.93', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.563', 'groupDescription': 'Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6810', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.22', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.92', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.545', 'groupDescription': 'Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6921', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.22', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.49', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.550', 'groupDescription': 'Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3702', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.49', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '0.21', 'pValueComment': 'P-value was 2-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.545', 'groupDescription': 'Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 8 , 12 , 14', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure and n=participants who were evaluable at given time points for each group."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG002', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG003', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG004', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'OG005', 'title': 'Sitagliptin 100 mg', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 14', 'description': 'Hemoglobin,hematocrit,red blood cells(RBC) count:less than \\[\\<\\]0.8\\*lower limit of normal\\[LLN\\],platelets:\\<0.5\\*LLN/greater than \\[\\>\\]1.75\\*upper limit of normal \\[ULN\\],white blood cells(WBC):\\<0.6\\*LLN or \\>1.5\\*ULN,lymphocytes,total neutrophils:\\<0.8\\*LLN or \\>1.2\\*ULN, basophils,eosinophil,monocytes:\\>1.2\\*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:\\>0.3\\*ULN,total protein,albumin:\\<0.8\\*LLN or \\>1.2\\*ULN;total bilirubin,direct bilirubin,indirect bilirubin:\\>1.5\\*ULN;triglycerides,cholesterol:\\>1.3\\*ULN, HDL:\\<0.8\\*LLN, LDL:\\>1.2\\*ULN,blood urea nitrogen,creatinine:\\>1.3\\*ULN,uric acid:\\>1.2\\*ULN;sodium: \\<0.95\\*LLN or \\>1.05\\*ULN,potassium,chloride,calcium,bicarbonate:\\<0.9\\*LLN or \\>1.1\\*ULN;creatine kinase:\\>2.0\\*ULN;glucose:\\<0.6\\*LLN or \\>1.5\\*ULN,urine WBC and RBC:\\>= 20/High Power Field \\[HPF\\]),urine epithelial cells (\\>=1 HPF),urine bacteria \\>20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (\\>=1);urine(protein,nitrite,mucus,leukocyte \\>=1 in urine dipstick test).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metformin 500 mg', 'description': 'Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'FG002', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'FG003', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'FG004', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'FG005', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'FG006', 'title': 'Sitagliptin 100 mg', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}], 'periods': [{'title': 'Run-in Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '376'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '335'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '56'}, {'groupId': 'FG006', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '52'}, {'groupId': 'FG005', 'numSubjects': '51'}, {'groupId': 'FG006', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Medication Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Total 615 participants were consented,of which 376 participants entered to run-in period to receive sponsor provided Metformin, 345 participants then randomized to study treatment,of these 335 were treated. Results were collected for 335 participants as data from 1 site (10 participants) were excluded due to major good clinical practice violations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}, {'value': '335', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'BG001', 'title': 'PF-04937319 3 mg', 'description': 'PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'BG002', 'title': 'PF-04937319 20 mg', 'description': 'PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'BG003', 'title': 'PF-04937319 50 mg', 'description': 'PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'BG004', 'title': 'PF-04937319 100 mg', 'description': 'PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'BG005', 'title': 'Sitagliptin 100 mg', 'description': 'Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=18 to =<44 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '93', 'groupId': 'BG006'}]}]}, {'title': '>=45 to =<64 years', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}, {'value': '242', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '143', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '192', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis population included all randomized participants who received at least 1 dose of study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'dispFirstSubmitDate': '2014-04-21', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2011-09-15', 'dispFirstSubmitQcDate': '2014-04-21', 'resultsFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2011-11-16', 'dispFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-06', 'studyFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12', 'timeFrame': 'Baseline (Day 1), Week 12', 'description': 'HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (\\<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8', 'timeFrame': 'Baseline(Day 1), Week 2, 4, 8', 'description': 'HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as \\<6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14', 'timeFrame': 'Baseline (Day 1), Week 1, 2, 4, 8, 12, 14'}, {'measure': 'Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12', 'timeFrame': 'Week 12', 'description': 'HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as \\<6.5 percent by the study-specific central laboratory used and data are presented in categories of \\<6.5 percent and \\<7 percent.'}, {'measure': 'Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data', 'timeFrame': 'Baseline (Day 1) up to Week 14', 'description': "Criteria for increase from baseline data: PR interval (percent change of greater than or equal to \\[\\>=\\] 25/50% \\[if baseline\\>200 then percent change of \\>25% counts; if baseline \\<=200 then percent change of \\>50% counts\\]; QRS complex (percent change of \\>=50%); QT Fridericia's correction (QTcF) interval (change of \\>=30 to \\<60 millisecond \\[msec\\], and change of \\>=60 msec)."}, {'measure': 'Number of Participants With Increase/Decrease From Baseline Vital Signs Data', 'timeFrame': 'Baseline (Day 1) up to Week 14', 'description': "Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of \\>=30 millimeter of mercury (mmHg); sitting diastolic BP of \\>=20 mmHg and pulse rate was based on investigator's discretion."}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline (Day 1) up to 14 days after last dose (up to 101 days)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.'}, {'measure': 'Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode', 'timeFrame': 'Baseline (Day 1) up to Week 14', 'description': 'A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =\\< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =\\<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =\\<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =\\<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.'}, {'measure': 'Number of Hypoglycemic Events (HAE) Episodes Per Participant', 'timeFrame': 'Baseline (Day 1) up to Week 14', 'description': 'A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported'}, {'measure': 'Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 8 , 12 , 14'}, {'measure': 'Number of Participants With Abnormal Laboratory Values', 'timeFrame': 'Baseline (Day 1) up to Week 14', 'description': 'Hemoglobin,hematocrit,red blood cells(RBC) count:less than \\[\\<\\]0.8\\*lower limit of normal\\[LLN\\],platelets:\\<0.5\\*LLN/greater than \\[\\>\\]1.75\\*upper limit of normal \\[ULN\\],white blood cells(WBC):\\<0.6\\*LLN or \\>1.5\\*ULN,lymphocytes,total neutrophils:\\<0.8\\*LLN or \\>1.2\\*ULN, basophils,eosinophil,monocytes:\\>1.2\\*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:\\>0.3\\*ULN,total protein,albumin:\\<0.8\\*LLN or \\>1.2\\*ULN;total bilirubin,direct bilirubin,indirect bilirubin:\\>1.5\\*ULN;triglycerides,cholesterol:\\>1.3\\*ULN, HDL:\\<0.8\\*LLN, LDL:\\>1.2\\*ULN,blood urea nitrogen,creatinine:\\>1.3\\*ULN,uric acid:\\>1.2\\*ULN;sodium: \\<0.95\\*LLN or \\>1.05\\*ULN,potassium,chloride,calcium,bicarbonate:\\<0.9\\*LLN or \\>1.1\\*ULN;creatine kinase:\\>2.0\\*ULN;glucose:\\<0.6\\*LLN or \\>1.5\\*ULN,urine WBC and RBC:\\>= 20/High Power Field \\[HPF\\]),urine epithelial cells (\\>=1 HPF),urine bacteria \\>20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (\\>=1);urine(protein,nitrite,mucus,leukocyte \\>=1 in urine dipstick test).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase 2', 'type 2 diabetes mellitus', 'PF-04937319'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25885172', 'type': 'DERIVED', 'citation': 'Amin NB, Aggarwal N, Pall D, Paragh G, Denney WS, Le V, Riggs M, Calle RA. Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes. Diabetes Obes Metab. 2015 Aug;17(8):751-9. doi: 10.1111/dom.12474. Epub 2015 May 11.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1621007&StudyName=Phase%202%20Study%20To%20Evaluate%20Safety%20And%20Efficacy%20Of%20Investigational%20Drug%20-%20PF04937319%20In%20Patients%20With%20Type%202%20Diabetes', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female\n\nExclusion Criteria:\n\n* patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening'}, 'identificationModule': {'nctId': 'NCT01475461', 'briefTitle': 'Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin', 'orgStudyIdInfo': {'id': 'B1621007'}, 'secondaryIdInfos': [{'id': '2011-004002-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PF-04937319 - Dose 1', 'interventionNames': ['Drug: PF-04937319 - 3mg']}, {'type': 'EXPERIMENTAL', 'label': 'PF-04937319 - Dose 2', 'interventionNames': ['Drug: PF-04937319 - 20mg']}, {'type': 'EXPERIMENTAL', 'label': 'PF-04937319 - Dose 3', 'interventionNames': ['Drug: PF-04937319 - 50mg']}, {'type': 'EXPERIMENTAL', 'label': 'PF-04937319 - 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