Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01298518
Status:
COMPLETED
Last Update Posted:
2012-11-06
First Post:
2011-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582730', 'term': 'PF-04620110'}]}}, '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': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.', 'otherNumAtRisk': 16, 'otherNumAffected': 12, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.', 'otherNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.', 'otherNumAtRisk': 16, 'otherNumAffected': 10, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=16, 16, 16)', 'categories': [{'measurements': [{'value': '1052.7', 'spread': '258.2', 'groupId': 'OG000'}, {'value': '954.7', 'spread': '249.2', 'groupId': 'OG001'}, {'value': '1005.4', 'spread': '190.0', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (n=15, 16, 15)', 'categories': [{'measurements': [{'value': '-118.3', 'spread': '269.0', 'groupId': 'OG000'}, {'value': '-143.0', 'spread': '235.8', 'groupId': 'OG001'}, {'value': '-117.7', 'spread': '157.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.', 'unitOfMeasure': 'mg*hr/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT glucose area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=16, 16, 16)', 'categories': [{'measurements': [{'value': '204.9', 'spread': '52.2', 'groupId': 'OG000'}, {'value': '188.0', 'spread': '53.2', 'groupId': 'OG001'}, {'value': '187.2', 'spread': '36.5', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (n=15, 16, 15)', 'categories': [{'measurements': [{'value': '-25.4', 'spread': '60.9', 'groupId': 'OG000'}, {'value': '-23.4', 'spread': '42.5', 'groupId': 'OG001'}, {'value': '-18.3', 'spread': '29.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 24 hours post-dose on Day 28', 'description': 'APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 APG value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=16, 16, 16)', 'categories': [{'measurements': [{'value': '122.9', 'spread': '82.9', 'groupId': 'OG000'}, {'value': '220.2', 'spread': '282.9', 'groupId': 'OG001'}, {'value': '156.7', 'spread': '63.3', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (n=15, 16, 15)', 'categories': [{'measurements': [{'value': '12.4', 'spread': '63.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '159.3', 'groupId': 'OG001'}, {'value': '41.0', 'spread': '46.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.', 'unitOfMeasure': 'micro-IU*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT insulin area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=16, 16, 16)', 'categories': [{'measurements': [{'value': '17.8', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '20.3', 'spread': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (15, 16, 15)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '5.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT C-peptide area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=16, 16, 16)', 'categories': [{'measurements': [{'value': '860.6', 'spread': '456.9', 'groupId': 'OG000'}, {'value': '1014.4', 'spread': '403.5', 'groupId': 'OG001'}, {'value': '961.2', 'spread': '380.7', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (n=13, 16, 15)', 'categories': [{'measurements': [{'value': '-185.0', 'spread': '436.7', 'groupId': 'OG000'}, {'value': '-100.5', 'spread': '268.4', 'groupId': 'OG001'}, {'value': '-110.3', 'spread': '245.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.', 'unitOfMeasure': 'mg*hr/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT net triglyceride area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Total amide GLP-1: Baseline (n=16, 15, 15)', 'categories': [{'measurements': [{'value': '54.4', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '63.2', 'spread': '36.4', 'groupId': 'OG001'}, {'value': '70.2', 'spread': '88.1', 'groupId': 'OG002'}]}]}, {'title': 'Total amide GLP-1: Change at Day 28 (n=15, 15, 14)', 'categories': [{'measurements': [{'value': '25.3', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '29.5', 'groupId': 'OG001'}, {'value': '-17.5', 'spread': '88.9', 'groupId': 'OG002'}]}]}, {'title': 'Active GLP-1: Baseline (n=15, 16, 15)', 'categories': [{'measurements': [{'value': '16.3', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '21.5', 'groupId': 'OG001'}, {'value': '13.9', 'spread': '11.4', 'groupId': 'OG002'}]}]}, {'title': 'Active GLP-1: Change at Day 28 (n=14, 14, 14)', 'categories': [{'measurements': [{'value': '12.5', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '23.6', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '11.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.', 'unitOfMeasure': 'pmol*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 total amide GLP-1 and active GLP-1 area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=15, 16, 16)', 'categories': [{'measurements': [{'value': '1372.8', 'spread': '617.2', 'groupId': 'OG000'}, {'value': '1181.0', 'spread': '614.6', 'groupId': 'OG001'}, {'value': '1619.2', 'spread': '627.7', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (n=14, 16, 15)', 'categories': [{'measurements': [{'value': '-141.6', 'spread': '726.1', 'groupId': 'OG000'}, {'value': '-277.1', 'spread': '541.4', 'groupId': 'OG001'}, {'value': '46.8', 'spread': '473.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.', 'unitOfMeasure': 'pg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 GIP area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=15, 16, 16)', 'categories': [{'measurements': [{'value': '409.0', 'spread': '192.4', 'groupId': 'OG000'}, {'value': '540.7', 'spread': '273.8', 'groupId': 'OG001'}, {'value': '395.0', 'spread': '114.6', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (n=14, 16, 14)', 'categories': [{'measurements': [{'value': '196.6', 'spread': '242.8', 'groupId': 'OG000'}, {'value': '96.7', 'spread': '194.2', 'groupId': 'OG001'}, {'value': '24.4', 'spread': '126.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.', 'unitOfMeasure': 'pg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PYY area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Glucose at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=16, 16, 16)', 'categories': [{'measurements': [{'value': '197.2', 'spread': '54.6', 'groupId': 'OG000'}, {'value': '180.9', 'spread': '54.7', 'groupId': 'OG001'}, {'value': '194.4', 'spread': '37.4', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (16, 16, 15)', 'categories': [{'measurements': [{'value': '-46.9', 'spread': '49.5', 'groupId': 'OG000'}, {'value': '-27.1', 'spread': '34.9', 'groupId': 'OG001'}, {'value': '-25.2', 'spread': '32.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day -1, Day 28', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting glucose value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=9, 10, 8)', 'categories': [{'measurements': [{'value': '10.2', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '27.2', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (n=8, 9, 8)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '12.8', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day -1, Day 28', 'unitOfMeasure': 'micro-IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting insulin value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Net Triglycerides at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=16, 16, 16)', 'categories': [{'measurements': [{'value': '189.1', 'spread': '111.7', 'groupId': 'OG000'}, {'value': '234.8', 'spread': '116.7', 'groupId': 'OG001'}, {'value': '187.4', 'spread': '81.6', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (16, 16, 15)', 'categories': [{'measurements': [{'value': '-31.2', 'spread': '103.6', 'groupId': 'OG000'}, {'value': '-18.4', 'spread': '52.1', 'groupId': 'OG001'}, {'value': '-19.2', 'spread': '56.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day -1, Day 28', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting net triglycerides value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=16, 16, 16)', 'categories': [{'measurements': [{'value': '853.4', 'spread': '293.4', 'groupId': 'OG000'}, {'value': '772.3', 'spread': '259.3', 'groupId': 'OG001'}, {'value': '730.2', 'spread': '174.9', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (n=15, 16, 15)', 'categories': [{'measurements': [{'value': '-34.9', 'spread': '377.2', 'groupId': 'OG000'}, {'value': '-41.4', 'spread': '202.9', 'groupId': 'OG001'}, {'value': '-90.4', 'spread': '157.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 6 to 10 hours post-dose on Day 28', 'description': 'Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.', 'unitOfMeasure': 'mg*hr/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-lunch glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'classes': [{'title': 'Baseline (n=16, 16, 16)', 'categories': [{'measurements': [{'value': '851.2', 'spread': '217.2', 'groupId': 'OG000'}, {'value': '763.9', 'spread': '215.8', 'groupId': 'OG001'}, {'value': '759.4', 'spread': '180.0', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28 (n=15, 16, 15)', 'categories': [{'measurements': [{'value': '-132.8', 'spread': '267.5', 'groupId': 'OG000'}, {'value': '-104.8', 'spread': '210.8', 'groupId': 'OG001'}, {'value': '-41.4', 'spread': '124.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1); 12 to 16 hours post-dose on Day 28', 'description': 'Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.', 'unitOfMeasure': 'mg*hr/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-dinner glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of PF-04620110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.0', 'spread': '39.3', 'groupId': 'OG000'}, {'value': '112.0', 'spread': '43.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post-morning dose on Day 28', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmax value.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post-morning dose on Day 28', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmin value.'}, {'type': 'SECONDARY', 'title': 'Time to Cmax (Tmax) of PF-04620110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '12.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours post-morning dose on Day 28', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Tmax value.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'OG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1055', 'spread': '397.7', 'groupId': 'OG000'}, {'value': '1027', 'spread': '441.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post-morning dose on Day 28', 'description': 'Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours.\n\nAUC (0-24) was computed using the linear trapezoidal method.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 AUC(0-24) value.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'FG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID', 'description': 'PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.'}, {'id': 'BG001', 'title': 'PF-04620110 5 mg QD', 'description': 'PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Matching placebo orally twice daily (BID) for 4 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '53.4', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '52.4', 'spread': '5.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '30.3', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '32.6', 'spread': '3.7', 'groupId': 'BG002'}, {'value': '31.6', 'spread': '3.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-05', 'studyFirstSubmitDate': '2011-01-28', 'resultsFirstSubmitDate': '2012-10-05', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-05', 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28', 'timeFrame': 'Baseline (Day -1); 24 hours post-dose on Day 28', 'description': 'APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.'}, {'measure': 'Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.'}, {'measure': 'Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.'}, {'measure': 'Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.'}, {'measure': 'Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.'}, {'measure': 'Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.'}, {'measure': 'Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28', 'timeFrame': 'Baseline (Day -1); 2 to 6 hours post-dose on Day 28', 'description': 'Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.'}, {'measure': 'Change From Baseline in Fasting Glucose at Day 28', 'timeFrame': '0 hour (pre-dose) on Day -1, Day 28'}, {'measure': 'Change From Baseline in Fasting Insulin at Day 28', 'timeFrame': '0 hour (pre-dose) on Day -1, Day 28'}, {'measure': 'Change From Baseline in Fasting Net Triglycerides at Day 28', 'timeFrame': '0 hour (pre-dose) on Day -1, Day 28'}, {'measure': 'Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28', 'timeFrame': 'Baseline (Day -1); 6 to 10 hours post-dose on Day 28', 'description': 'Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.'}, {'measure': 'Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28', 'timeFrame': 'Baseline (Day -1); 12 to 16 hours post-dose on Day 28', 'description': 'Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of PF-04620110', 'timeFrame': '24 hours post-morning dose on Day 28'}, {'measure': 'Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110', 'timeFrame': '24 hours post-morning dose on Day 28'}, {'measure': 'Time to Cmax (Tmax) of PF-04620110', 'timeFrame': '24 hours post-morning dose on Day 28'}, {'measure': 'Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110', 'timeFrame': '24 hours post-morning dose on Day 28', 'description': 'Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours.\n\nAUC (0-24) was computed using the linear trapezoidal method.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multiple dose study in type 2 diabetes patients'], 'conditions': ['Type 2 Diabetes Patients']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0961007&StudyName=A%20Multiple%20Dose%20Study%20Of%20PF-04620110%20In%20Type%202%20Diabetes%20Patients', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and/or female subjects between the ages of 18 and 60 years;\n* Body Mass Index (BMI) of \\>25.0 kg/m2 and \\<40 kg/m2;\n* Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;\n* Subjects who have been on well-tolerated and stable doses of metformin\n\nExclusion Criteria:\n\n* Recent evidence (6 months prior to screening) or history of unstable major organ disease;\n* Diagnosis of Type 1 diabetes mellitus;\n* Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;\n* Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;'}, 'identificationModule': {'nctId': 'NCT01298518', 'briefTitle': 'A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1B, Randomized, Double-Blind, Placebo-Controlled Trial To Assess The Efficacy And Safety Of 4-Week Administration Of Multiple Oral Doses Of PF-04620110 In Type 2 Diabetes Mellitus Subjects With Insufficient Glycemic Control On Metformin', 'orgStudyIdInfo': {'id': 'B0961007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04620110', 'interventionNames': ['Drug: PF-04620110']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-04620110', 'type': 'DRUG', 'description': '5 mg of PF-04620110 given once daily', 'armGroupLabels': ['PF-04620110']}, {'name': 'PF-04620110', 'type': 'DRUG', 'description': '2.5 mg of PF-04620110 given twice daily', 'armGroupLabels': ['PF-04620110']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo giving for 4 weeks', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33169', 'city': 'Miami Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.94204, 'lon': -80.2456}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}