Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-25 @ 6:09 AM
Study NCT ID:
NCT01792635
Status:
TERMINATED
Last Update Posted:
2017-02-16
First Post:
2012-12-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClnicalTrials.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}, 'limitationsAndCaveats': {'description': 'Part B of the study was terminated due to the safety issue. Due to the low number of participants who completed the study, there are no conclusions for PK or PD in Part B. The prioritization of Part A endpoints was done by inputs from team.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to follow-up (up to approximately 3 days after the last clamp procedure in Part A and up to approximately 10 to 14 days after the last study drug administration in Part B)', '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': 'All Participants in Part A', 'description': "Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m\\^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m\\^2/min.", 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glucose Infusion Rates (GIR) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants in Part A', 'description': "Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m\\^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m\\^2/min."}], 'classes': [{'title': 'Clamp 1 GIR1', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000', 'lowerLimit': '153', 'upperLimit': '229'}]}]}, {'title': 'Clamp 1 GIR2', 'categories': [{'measurements': [{'value': '780', 'groupId': 'OG000', 'lowerLimit': '580', 'upperLimit': '980'}]}]}, {'title': 'Clamp 2 GIR1', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000', 'lowerLimit': '132', 'upperLimit': '172'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'GIR obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. Assessment of whole body insulin sensitivity was performed during the steady states of the low insulin infusion rate (ie, Step 1) and during the steady state of the high insulin infusion rate (ie, Step 2). These indices were called GIR1 and GIR2, respectively.', 'unitOfMeasure': 'mg/min', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized and who had at least one euglycemic hyperinsulinemic clamp'}, {'type': 'PRIMARY', 'title': 'Endogenous Gucose Production (EGP) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants in Part A', 'description': "Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m\\^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m\\^2/min."}], 'classes': [{'title': 'Clamp 1 EGP0', 'categories': [{'measurements': [{'value': '1.79', 'groupId': 'OG000', 'lowerLimit': '1.48', 'upperLimit': '1.99'}]}]}, {'title': 'Clamp 1 EGP1', 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '0.98'}]}]}, {'title': 'Clamp 1 EGP2', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '0.36'}]}]}, {'title': 'Clamp 2 EGP0', 'categories': [{'measurements': [{'value': '1.68', 'groupId': 'OG000', 'lowerLimit': '1.59', 'upperLimit': '1.89'}]}]}, {'title': 'Clamp 2 EGP1', 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.71', 'upperLimit': '0.98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 day', 'description': 'EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2). Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. EGP was measured under basal conditions; then during the low dose insulin infusion EGP was partially suppressed (hepatic insulin sensitivity), while during the high dose insulin infusion, EGP was almost completely suppressed and peripheral glucose uptake was maximally stimulated (peripheral insulin sensitivity).', 'unitOfMeasure': 'mg/kilogram (kg) body weight (BW)/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized and who had at least one euglycemic hyperinsulinemic clamp'}, {'type': 'PRIMARY', 'title': '[6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants in Part A', 'description': "Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m\\^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m\\^2/min."}], 'classes': [{'title': 'Clamp 1', 'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '2.94', 'upperLimit': '2.98'}]}]}, {'title': 'Clamp 2', 'categories': [{'measurements': [{'value': '2.97', 'groupId': 'OG000', 'lowerLimit': '2.88', 'upperLimit': '3.06'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': '\\[6,6-2H2\\] PGE was the molar fraction of labeled glucose measured in plasma. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity.', 'unitOfMeasure': 'percentage enrichment of plasma glucose', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized and who had at least one euglycemic hyperinsulinemic clamp'}, {'type': 'PRIMARY', 'title': 'Rate of Appearance of Glucose (Ra) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants in Part A', 'description': "Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m\\^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m\\^2/min."}], 'classes': [{'title': 'Clamp 1 Step 1', 'categories': [{'measurements': [{'value': '3.575', 'groupId': 'OG000', 'lowerLimit': '2.74', 'upperLimit': '4.41'}]}]}, {'title': 'Clamp 1 Step 2', 'categories': [{'measurements': [{'value': '14.829', 'groupId': 'OG000', 'lowerLimit': '9.90', 'upperLimit': '19.76'}]}]}, {'title': 'Clamp 2 Step 1', 'categories': [{'measurements': [{'value': '2.859', 'groupId': 'OG000', 'lowerLimit': '2.24', 'upperLimit': '3.47'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Rate of appearance of glucose (Ra) in fasting state and during insulin infusions (Step 1 and Step 2).', 'unitOfMeasure': 'mg/kg BW/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.'}, {'type': 'PRIMARY', 'title': 'Whole-body Glucose Uptake in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants in Part A', 'description': "Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m\\^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m\\^2/min."}], 'classes': [{'categories': [{'measurements': [{'value': '14.829', 'groupId': 'OG000', 'lowerLimit': '9.90', 'upperLimit': '19.76'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp', 'unitOfMeasure': 'mg/kg BW/min', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.'}, {'type': 'PRIMARY', 'title': 'Whole-body Glucose Uptake in Part B in Placebo Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'Step 2 Value 1', 'categories': [{'measurements': [{'value': '4.245', 'groupId': 'OG000', 'lowerLimit': '4.18', 'upperLimit': '4.41'}]}]}, {'title': 'Step 2 Value 2', 'categories': [{'measurements': [{'value': '6.325', 'groupId': 'OG000', 'lowerLimit': '6.26', 'upperLimit': '6.45'}]}]}, {'title': 'Step 2 Value 3', 'categories': [{'measurements': [{'value': '2.793', 'groupId': 'OG000', 'lowerLimit': '2.72', 'upperLimit': '2.85'}]}]}, {'title': 'Step 2 Value 4', 'categories': [{'measurements': [{'value': '6.835', 'groupId': 'OG000', 'lowerLimit': '6.56', 'upperLimit': '7.38'}]}]}, {'title': 'Step 2 Value 5', 'categories': [{'measurements': [{'value': '4.400', 'groupId': 'OG000', 'lowerLimit': '3.97', 'upperLimit': '5.23'}]}]}, {'title': 'Step 2 Value 6', 'categories': [{'measurements': [{'value': '3.940', 'groupId': 'OG000', 'lowerLimit': '3.86', 'upperLimit': '3.98'}]}]}, {'title': 'Step 2 Value 7', 'categories': [{'measurements': [{'value': '4.553', 'groupId': 'OG000', 'lowerLimit': '4.37', 'upperLimit': '4.62'}]}]}, {'title': 'Step 2 Value 8', 'categories': [{'measurements': [{'value': '4.225', 'groupId': 'OG000', 'lowerLimit': '4.16', 'upperLimit': '4.40'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp', 'unitOfMeasure': 'mg/kg BW/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.'}, {'type': 'PRIMARY', 'title': 'Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'Step 2 Value 1', 'categories': [{'measurements': [{'value': '3.775', 'groupId': 'OG000', 'lowerLimit': '3.70', 'upperLimit': '3.83'}]}]}, {'title': 'Step 2 Value 2', 'categories': [{'measurements': [{'value': '9.033', 'groupId': 'OG000', 'lowerLimit': '8.95', 'upperLimit': '9.08'}]}]}, {'title': 'Step 2 Value 3', 'categories': [{'measurements': [{'value': '8.903', 'groupId': 'OG000', 'lowerLimit': '8.33', 'upperLimit': '9.37'}]}]}, {'title': 'Step 2 Value 4', 'categories': [{'measurements': [{'value': '11.310', 'groupId': 'OG000', 'lowerLimit': '11.13', 'upperLimit': '11.47'}]}]}, {'title': 'Step 2 Value 5', 'categories': [{'measurements': [{'value': '4.133', 'groupId': 'OG000', 'lowerLimit': '3.98', 'upperLimit': '4.50'}]}]}, {'title': 'Step 2 Value 6', 'categories': [{'measurements': [{'value': '6.763', 'groupId': 'OG000', 'lowerLimit': '5.98', 'upperLimit': '7.93'}]}]}, {'title': 'Step 2 Value 7', 'categories': [{'measurements': [{'value': '8.243', 'groupId': 'OG000', 'lowerLimit': '8.06', 'upperLimit': '8.73'}]}]}, {'title': 'Step 2 Value 8', 'categories': [{'measurements': [{'value': '7.180', 'groupId': 'OG000', 'lowerLimit': '7.03', 'upperLimit': '7.39'}]}]}, {'title': 'Step 2 Value 9', 'categories': [{'measurements': [{'value': '10.113', 'groupId': 'OG000', 'lowerLimit': '9.80', 'upperLimit': '10.28'}]}]}, {'title': 'Step 2 Value 10', 'categories': [{'measurements': [{'value': '6.205', 'groupId': 'OG000', 'lowerLimit': '6.16', 'upperLimit': '6.31'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp', 'unitOfMeasure': 'mg/kg BW/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}, {'id': 'OG001', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'Participants w ith AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Participants w ith SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Participants discontinued due to AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were admitted to the clinical research unit (CRU) on Day -5'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Test Abnormalities in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}, {'id': 'OG001', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)', 'description': 'Number of participants with laboratory test abnormalities without regard to baseline abnormality. The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \\[RBC\\] count, platelet count, white blood cell \\[WBC\\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \\[BUN\\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \\[AST\\], alanine aminotransferase \\[ALT\\], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatine phosphokinase); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone \\[FSH\\], urine drug screen, lipid profile and very-low-density lipoproteins \\[VLDL\\], hemoglobin A1c \\[HbA1c\\], C-peptide, thyroid-stimulating hormone \\[TSH\\], Hepatitis B and C, human immunodeficiency virus \\[HIV\\], triglycerides, urine creatinine).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were admitted to the Clinical Research Unit (CRU) on Day -5'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}, {'id': 'OG001', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'SBP <90 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DBP <50 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pulse Rate <40 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pulse Rate >120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP maximum increase from baseline >=30 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DBP maximum increase from baseline >=20 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP maximum decrease from baseline >=30 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'DBP maximum decrease from baseline >=20 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)', 'description': 'Criteria for potentially clinical important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of less than (\\<) 90 millimeters of mercury (mm Hg) or change in sitting SBP of greater or equal to (\\>=)30 mm Hg, sitting diastolic blood pressure (DBP) of \\<50 mm Hg or change in sitting DBP of \\>=20 mm Hg, sitting pulse rate of \\<40 or greater than (\\>) 120 beats per minute (bpm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were admitted to the CRU on Day -5'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}, {'id': 'OG001', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'QTc increase from Baseline of >=60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'QTcF increase from Baseline of >=60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)', 'description': 'Criteria for PCI changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) \\>=300 milliseconds (msec) and increase of \\>=25% from baseline when baseline \\>200 msec or increase of \\>=50% when baseline less than or equal to (\\<=) 200 msec; the time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS interval) \\>=140 msec and increase of \\>=50% from baseline; the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT), corrected for heart rate (QTc) using the Fridericia formula (QTcF) of 450 to \\< 480 msec and \\>=480 msec, or an increase from baseline of 30 to \\<60 msec or \\>=60 msec.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were admitted to the CRU on Day -5.'}, {'type': 'SECONDARY', 'title': 'GIR in Part B in Placebo Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'GIR1 Value 1', 'categories': [{'measurements': [{'value': '139.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '150'}]}]}, {'title': 'GIR1 Value 2', 'categories': [{'measurements': [{'value': '178.3', 'groupId': 'OG000', 'lowerLimit': '176', 'upperLimit': '246'}]}]}, {'title': 'GIR1 Value 3', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '97'}]}]}, {'title': 'GIR1 Value 4', 'categories': [{'measurements': [{'value': '196.5', 'groupId': 'OG000', 'lowerLimit': '181', 'upperLimit': '197'}]}]}, {'title': 'GIR1 Value 5', 'categories': [{'measurements': [{'value': '145.7', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '161'}]}]}, {'title': 'GIR1 Value 6', 'categories': [{'measurements': [{'value': '104.7', 'groupId': 'OG000', 'lowerLimit': '103', 'upperLimit': '140'}]}]}, {'title': 'GIR1 Value 7', 'categories': [{'measurements': [{'value': '154.7', 'groupId': 'OG000', 'lowerLimit': '143', 'upperLimit': '218'}]}]}, {'title': 'GIR1 Value 8', 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '86'}]}]}, {'title': 'GIR2 Value 1', 'categories': [{'measurements': [{'value': '413.9', 'groupId': 'OG000', 'lowerLimit': '411', 'upperLimit': '461'}]}]}, {'title': 'GIR2 Value 2', 'categories': [{'measurements': [{'value': '645.0', 'groupId': 'OG000', 'lowerLimit': '645', 'upperLimit': '645'}]}]}, {'title': 'GIR2 Value 3', 'categories': [{'measurements': [{'value': '293.4', 'groupId': 'OG000', 'lowerLimit': '217', 'upperLimit': '296'}]}]}, {'title': 'GIR2 Value 4', 'categories': [{'measurements': [{'value': '668.2', 'groupId': 'OG000', 'lowerLimit': '610', 'upperLimit': '711'}]}]}, {'title': 'GIR2 Value 5', 'categories': [{'measurements': [{'value': '400.4', 'groupId': 'OG000', 'lowerLimit': '368', 'upperLimit': '504'}]}]}, {'title': 'GIR2 Value 6', 'categories': [{'measurements': [{'value': '359.3', 'groupId': 'OG000', 'lowerLimit': '289', 'upperLimit': '363'}]}]}, {'title': 'GIR2 Value 7', 'categories': [{'measurements': [{'value': '338.0', 'groupId': 'OG000', 'lowerLimit': '338', 'upperLimit': '338'}]}]}, {'title': 'GIR2 Value 8', 'categories': [{'measurements': [{'value': '343.3', 'groupId': 'OG000', 'lowerLimit': '322', 'upperLimit': '344'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.', 'unitOfMeasure': 'mg/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.'}, {'type': 'SECONDARY', 'title': 'GIR in Part B in PF-05175157 200 mg BID Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'GIR1 Value 1', 'categories': [{'measurements': [{'value': '170.5', 'groupId': 'OG000', 'lowerLimit': '118', 'upperLimit': '191'}]}]}, {'title': 'GIR1 Value 2', 'categories': [{'measurements': [{'value': '425.0', 'groupId': 'OG000', 'lowerLimit': '367', 'upperLimit': '427'}]}]}, {'title': 'GIR1 Value 3', 'categories': [{'measurements': [{'value': '334.2', 'groupId': 'OG000', 'lowerLimit': '311', 'upperLimit': '335'}]}]}, {'title': 'GIR1 Value 4', 'categories': [{'measurements': [{'value': '409.3', 'groupId': 'OG000', 'lowerLimit': '277', 'upperLimit': '521'}]}]}, {'title': 'GIR1 Value 5', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '50'}]}]}, {'title': 'GIR1 Value 6', 'categories': [{'measurements': [{'value': '160.9', 'groupId': 'OG000', 'lowerLimit': '160', 'upperLimit': '188'}]}]}, {'title': 'GIR1 Value 7', 'categories': [{'measurements': [{'value': '113.2', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '116'}]}]}, {'title': 'GIR1 Value 8', 'categories': [{'measurements': [{'value': '157.7', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '225'}]}]}, {'title': 'GIR1 Value 9', 'categories': [{'measurements': [{'value': '215.2', 'groupId': 'OG000', 'lowerLimit': '201', 'upperLimit': '236'}]}]}, {'title': 'GIR1 Value 10', 'categories': [{'measurements': [{'value': '159.9', 'groupId': 'OG000', 'lowerLimit': '159', 'upperLimit': '178'}]}]}, {'title': 'GIR2 Value 1', 'categories': [{'measurements': [{'value': '359.2', 'groupId': 'OG000', 'lowerLimit': '270', 'upperLimit': '368'}]}]}, {'title': 'GIR2 Value 2', 'categories': [{'measurements': [{'value': '896.5', 'groupId': 'OG000', 'lowerLimit': '871', 'upperLimit': '921'}]}]}, {'title': 'GIR2 Value 3', 'categories': [{'measurements': [{'value': '896.3', 'groupId': 'OG000', 'lowerLimit': '864', 'upperLimit': '1064'}]}]}, {'title': 'GIR2 Value 4', 'categories': [{'measurements': [{'value': '1078.5', 'groupId': 'OG000', 'lowerLimit': '1068', 'upperLimit': '1079'}]}]}, {'title': 'GIR2 Value 5', 'categories': [{'measurements': [{'value': '357.6', 'groupId': 'OG000', 'lowerLimit': '357', 'upperLimit': '370'}]}]}, {'title': 'GIR2 Value 6', 'categories': [{'measurements': [{'value': '564.0', 'groupId': 'OG000', 'lowerLimit': '520', 'upperLimit': '656'}]}]}, {'title': 'GIR2 Value 7', 'categories': [{'measurements': [{'value': '693.1', 'groupId': 'OG000', 'lowerLimit': '666', 'upperLimit': '728'}]}]}, {'title': 'GIR2 Value 8', 'categories': [{'measurements': [{'value': '647.2', 'groupId': 'OG000', 'lowerLimit': '623', 'upperLimit': '681'}]}]}, {'title': 'GIR2 Value 9', 'categories': [{'measurements': [{'value': '889.4', 'groupId': 'OG000', 'lowerLimit': '821', 'upperLimit': '893'}]}]}, {'title': 'GIR2 Value 10', 'categories': [{'measurements': [{'value': '519.5', 'groupId': 'OG000', 'lowerLimit': '512', 'upperLimit': '540'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.', 'unitOfMeasure': 'mg/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.'}, {'type': 'SECONDARY', 'title': 'EGP in Part B in Placebo Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'EGP0 Value 1', 'categories': [{'measurements': [{'value': '1.540', 'groupId': 'OG000', 'lowerLimit': '1.49', 'upperLimit': '1.60'}]}]}, {'title': 'EGP0 Value 2', 'categories': [{'measurements': [{'value': '1.690', 'groupId': 'OG000', 'lowerLimit': '1.64', 'upperLimit': '1.75'}]}]}, {'title': 'EGP0 Value 3', 'categories': [{'measurements': [{'value': '1.285', 'groupId': 'OG000', 'lowerLimit': '1.24', 'upperLimit': '1.33'}]}]}, {'title': 'EGP0 Value 4', 'categories': [{'measurements': [{'value': '1.575', 'groupId': 'OG000', 'lowerLimit': '1.55', 'upperLimit': '1.62'}]}]}, {'title': 'EGP0 Value 5', 'categories': [{'measurements': [{'value': '1.965', 'groupId': 'OG000', 'lowerLimit': '1.89', 'upperLimit': '2.04'}]}]}, {'title': 'EGP0 Value 6', 'categories': [{'measurements': [{'value': '1.538', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '1.58'}]}]}, {'title': 'EGP0 Value 7', 'categories': [{'measurements': [{'value': '1.518', 'groupId': 'OG000', 'lowerLimit': '1.47', 'upperLimit': '1.56'}]}]}, {'title': 'EGP0 Value 8', 'categories': [{'measurements': [{'value': '1.518', 'groupId': 'OG000', 'lowerLimit': '1.49', 'upperLimit': '1.56'}]}]}, {'title': 'EGP1 Value 1', 'categories': [{'measurements': [{'value': '0.600', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '0.66'}]}]}, {'title': 'EGP1 Value 2', 'categories': [{'measurements': [{'value': '0.585', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '0.61'}]}]}, {'title': 'EGP1 Value 3', 'categories': [{'measurements': [{'value': '0.525', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.59'}]}]}, {'title': 'EGP1 Value 4', 'categories': [{'measurements': [{'value': '0.500', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.52'}]}]}, {'title': 'EGP1 Value 5', 'categories': [{'measurements': [{'value': '0.808', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '0.86'}]}]}, {'title': 'EGP1 Value 6', 'categories': [{'measurements': [{'value': '0.830', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '0.84'}]}]}, {'title': 'EGP1 Value 7', 'categories': [{'measurements': [{'value': '0.560', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '0.58'}]}]}, {'title': 'EGP1 Value 8', 'categories': [{'measurements': [{'value': '0.825', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '0.85'}]}]}, {'title': 'EGP2 Value 1', 'categories': [{'measurements': [{'value': '0.200', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.22'}]}]}, {'title': 'EGP2 Value 2', 'categories': [{'measurements': [{'value': '-0.063', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '-0.03'}]}]}, {'title': 'EGP2 Value 3', 'categories': [{'measurements': [{'value': '-0.050', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '-0.01'}]}]}, {'title': 'EGP2 Value 4', 'categories': [{'measurements': [{'value': '0.280', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.31'}]}]}, {'title': 'EGP2 Value 5', 'categories': [{'measurements': [{'value': '0.145', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.23'}]}]}, {'title': 'EGP2 Value 6', 'categories': [{'measurements': [{'value': '0.223', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.24'}]}]}, {'title': 'EGP2 Value 7', 'categories': [{'measurements': [{'value': '0.180', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.19'}]}]}, {'title': 'EGP2 Value 8', 'categories': [{'measurements': [{'value': '0.405', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '0.46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)', 'unitOfMeasure': 'mg/kg fat free mass (FFM)/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.'}, {'type': 'SECONDARY', 'title': 'EGP in Part B in PF-05175157 200 mg BID Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'EGP0 Value 1', 'categories': [{'measurements': [{'value': '1.240', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '1.27'}]}]}, {'title': 'EGP0 Value 2', 'categories': [{'measurements': [{'value': '1.445', 'groupId': 'OG000', 'lowerLimit': '1.42', 'upperLimit': '1.46'}]}]}, {'title': 'EGP0 Value 3', 'categories': [{'measurements': [{'value': '2.083', 'groupId': 'OG000', 'lowerLimit': '2.03', 'upperLimit': '2.15'}]}]}, {'title': 'EGP0 Value 4', 'categories': [{'measurements': [{'value': '1.708', 'groupId': 'OG000', 'lowerLimit': '1.68', 'upperLimit': '1.73'}]}]}, {'title': 'EGP0 Value 5', 'categories': [{'measurements': [{'value': '1.695', 'groupId': 'OG000', 'lowerLimit': '1.67', 'upperLimit': '1.72'}]}]}, {'title': 'EGP0 Value 6', 'categories': [{'measurements': [{'value': '1.615', 'groupId': 'OG000', 'lowerLimit': '1.59', 'upperLimit': '1.65'}]}]}, {'title': 'EGP0 Value 7', 'categories': [{'measurements': [{'value': '1.690', 'groupId': 'OG000', 'lowerLimit': '1.64', 'upperLimit': '1.75'}]}]}, {'title': 'EGP0 Value 8', 'categories': [{'measurements': [{'value': '1.393', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '1.46'}]}]}, {'title': 'EGP0 Value 9', 'categories': [{'measurements': [{'value': '1.448', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': '1.46'}]}]}, {'title': 'EGP0 Value 10', 'categories': [{'measurements': [{'value': '1.345', 'groupId': 'OG000', 'lowerLimit': '1.33', 'upperLimit': '1.36'}]}]}, {'title': 'EGP1 Value 1', 'categories': [{'measurements': [{'value': '0.568', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.59'}]}]}, {'title': 'EGP1 Value 2', 'categories': [{'measurements': [{'value': '0.250', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.28'}]}]}, {'title': 'EGP1 Value 3', 'categories': [{'measurements': [{'value': '0.788', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.89'}]}]}, {'title': 'EGP1 Value 4', 'categories': [{'measurements': [{'value': '0.575', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.62'}]}]}, {'title': 'EGP1 Value 5', 'categories': [{'measurements': [{'value': '1.183', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '1.22'}]}]}, {'title': 'EGP1 Value 6', 'categories': [{'measurements': [{'value': '0.538', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '0.55'}]}]}, {'title': 'EGP1 Value 7', 'categories': [{'measurements': [{'value': '0.765', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '0.78'}]}]}, {'title': 'EGP1 Value 8', 'categories': [{'measurements': [{'value': '0.555', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '0.58'}]}]}, {'title': 'EGP1 Value 9', 'categories': [{'measurements': [{'value': '0.193', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.23'}]}]}, {'title': 'EGP1 Value 10', 'categories': [{'measurements': [{'value': '0.418', 'groupId': 'OG000', 'lowerLimit': '0.35', 'upperLimit': '0.45'}]}]}, {'title': 'EGP2 Value 1', 'categories': [{'measurements': [{'value': '0.253', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.29'}]}]}, {'title': 'EGP2 Value 2', 'categories': [{'measurements': [{'value': '0.165', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.21'}]}]}, {'title': 'EGP2 Value 3', 'categories': [{'measurements': [{'value': '-0.035', 'groupId': 'OG000', 'lowerLimit': '-0.43', 'upperLimit': '0.14'}]}]}, {'title': 'EGP2 Value 4', 'categories': [{'measurements': [{'value': '0.243', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.39'}]}]}, {'title': 'EGP2 Value 5', 'categories': [{'measurements': [{'value': '0.543', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.67'}]}]}, {'title': 'EGP2 Value 6', 'categories': [{'measurements': [{'value': '0.110', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.15'}]}]}, {'title': 'EGP2 Value 7', 'categories': [{'measurements': [{'value': '0.190', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.24'}]}]}, {'title': 'EGP2 Value 8', 'categories': [{'measurements': [{'value': '-0.313', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '-0.23'}]}]}, {'title': 'EGP2 Value 9', 'categories': [{'measurements': [{'value': '-0.253', 'groupId': 'OG000', 'lowerLimit': '-0.34', 'upperLimit': '-0.20'}]}]}, {'title': 'EGP2 Value 10', 'categories': [{'measurements': [{'value': '0.198', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '0.21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)', 'unitOfMeasure': 'mg/kg fat free mass (FFM)/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.'}, {'type': 'SECONDARY', 'title': 'Ra in Part B in Placebo Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'Step 2 Value 1', 'categories': [{'measurements': [{'value': '4.245', 'groupId': 'OG000', 'lowerLimit': '4.18', 'upperLimit': '4.41'}]}]}, {'title': 'Step 2 Value 2', 'categories': [{'measurements': [{'value': '6.325', 'groupId': 'OG000', 'lowerLimit': '6.26', 'upperLimit': '6.45'}]}]}, {'title': 'Step 2 Value 3', 'categories': [{'measurements': [{'value': '2.793', 'groupId': 'OG000', 'lowerLimit': '2.72', 'upperLimit': '2.85'}]}]}, {'title': 'Step 2 Value 4', 'categories': [{'measurements': [{'value': '6.835', 'groupId': 'OG000', 'lowerLimit': '6.56', 'upperLimit': '7.38'}]}]}, {'title': 'Step 2 Value 5', 'categories': [{'measurements': [{'value': '4.400', 'groupId': 'OG000', 'lowerLimit': '3.97', 'upperLimit': '5.23'}]}]}, {'title': 'Step 2 Value 6', 'categories': [{'measurements': [{'value': '3.940', 'groupId': 'OG000', 'lowerLimit': '3.86', 'upperLimit': '3.98'}]}]}, {'title': 'Step 2 Value 7', 'categories': [{'measurements': [{'value': '4.553', 'groupId': 'OG000', 'lowerLimit': '4.37', 'upperLimit': '4.62'}]}]}, {'title': 'Step 2 Value 8', 'categories': [{'measurements': [{'value': '4.225', 'groupId': 'OG000', 'lowerLimit': '4.16', 'upperLimit': '4.40'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Ra in fasting state and during insulin infusions (Step 1 and Step 2).', 'unitOfMeasure': 'mg/kg BW/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.'}, {'type': 'SECONDARY', 'title': 'Ra in Part B in PF-05175157 200 mg BID Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'classes': [{'title': 'Step 2 Value 1', 'categories': [{'measurements': [{'value': '3.775', 'groupId': 'OG000', 'lowerLimit': '3.70', 'upperLimit': '3.83'}]}]}, {'title': 'Step 2 Value 2', 'categories': [{'measurements': [{'value': '9.033', 'groupId': 'OG000', 'lowerLimit': '8.95', 'upperLimit': '9.08'}]}]}, {'title': 'Step 2 Value 3', 'categories': [{'measurements': [{'value': '8.903', 'groupId': 'OG000', 'lowerLimit': '8.33', 'upperLimit': '9.37'}]}]}, {'title': 'Step 2 Value 4', 'categories': [{'measurements': [{'value': '11.310', 'groupId': 'OG000', 'lowerLimit': '11.13', 'upperLimit': '11.47'}]}]}, {'title': 'Step 2 Value 5', 'categories': [{'measurements': [{'value': '4.133', 'groupId': 'OG000', 'lowerLimit': '3.98', 'upperLimit': '4.50'}]}]}, {'title': 'Step 2 Value 6', 'categories': [{'measurements': [{'value': '6.763', 'groupId': 'OG000', 'lowerLimit': '5.98', 'upperLimit': '7.93'}]}]}, {'title': 'Step 2 Value 7', 'categories': [{'measurements': [{'value': '8.243', 'groupId': 'OG000', 'lowerLimit': '8.06', 'upperLimit': '8.73'}]}]}, {'title': 'Step 2 Value 8', 'categories': [{'measurements': [{'value': '7.180', 'groupId': 'OG000', 'lowerLimit': '7.03', 'upperLimit': '7.39'}]}]}, {'title': 'Step 2 Value 9', 'categories': [{'measurements': [{'value': '10.113', 'groupId': 'OG000', 'lowerLimit': '9.80', 'upperLimit': '10.28'}]}]}, {'title': 'Step 2 Value 10', 'categories': [{'measurements': [{'value': '6.205', 'groupId': 'OG000', 'lowerLimit': '6.16', 'upperLimit': '6.31'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Ra in fasting state and during insulin infusions (Step 1 and Step 2).', 'unitOfMeasure': 'mg/kg BW/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants in Part A', 'description': "Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m\\^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m\\^2/min."}, {'id': 'FG001', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}, {'id': 'FG002', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}], 'periods': [{'title': 'Part A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants in Part A', 'description': "Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual's insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m\\^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m\\^2/min."}, {'id': 'BG001', 'title': 'Placebo - Part B', 'description': 'Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}, {'id': 'BG002', 'title': 'PF-05175157 200 mg Twice a Day - Part B', 'description': 'Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '49.3', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '55.1', 'spread': '4.6', 'groupId': 'BG002'}, {'value': '51.9', 'spread': '7.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'The study was terminated prematurely on 16 May 2014 due to a safety concern.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-22', 'studyFirstSubmitDate': '2012-12-20', 'resultsFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2013-02-13', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-22', 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose Infusion Rates (GIR) in Part A', 'timeFrame': '1 day', 'description': 'GIR obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. Assessment of whole body insulin sensitivity was performed during the steady states of the low insulin infusion rate (ie, Step 1) and during the steady state of the high insulin infusion rate (ie, Step 2). These indices were called GIR1 and GIR2, respectively.'}, {'measure': 'Endogenous Gucose Production (EGP) in Part A', 'timeFrame': '1 day', 'description': 'EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2). Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. EGP was measured under basal conditions; then during the low dose insulin infusion EGP was partially suppressed (hepatic insulin sensitivity), while during the high dose insulin infusion, EGP was almost completely suppressed and peripheral glucose uptake was maximally stimulated (peripheral insulin sensitivity).'}, {'measure': '[6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A', 'timeFrame': '1 day', 'description': '\\[6,6-2H2\\] PGE was the molar fraction of labeled glucose measured in plasma. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity.'}, {'measure': 'Rate of Appearance of Glucose (Ra) in Part A', 'timeFrame': '1 day', 'description': 'Rate of appearance of glucose (Ra) in fasting state and during insulin infusions (Step 1 and Step 2).'}, {'measure': 'Whole-body Glucose Uptake in Part A', 'timeFrame': '1 day', 'description': 'Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp'}, {'measure': 'Whole-body Glucose Uptake in Part B in Placebo Group', 'timeFrame': '6 weeks', 'description': 'Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp'}, {'measure': 'Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group', 'timeFrame': '6 weeks', 'description': 'Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B', 'timeFrame': 'Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities in Part B', 'timeFrame': 'Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)', 'description': 'Number of participants with laboratory test abnormalities without regard to baseline abnormality. The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \\[RBC\\] count, platelet count, white blood cell \\[WBC\\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \\[BUN\\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \\[AST\\], alanine aminotransferase \\[ALT\\], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatine phosphokinase); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone \\[FSH\\], urine drug screen, lipid profile and very-low-density lipoproteins \\[VLDL\\], hemoglobin A1c \\[HbA1c\\], C-peptide, thyroid-stimulating hormone \\[TSH\\], Hepatitis B and C, human immunodeficiency virus \\[HIV\\], triglycerides, urine creatinine).'}, {'measure': 'Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B', 'timeFrame': 'Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)', 'description': 'Criteria for potentially clinical important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of less than (\\<) 90 millimeters of mercury (mm Hg) or change in sitting SBP of greater or equal to (\\>=)30 mm Hg, sitting diastolic blood pressure (DBP) of \\<50 mm Hg or change in sitting DBP of \\>=20 mm Hg, sitting pulse rate of \\<40 or greater than (\\>) 120 beats per minute (bpm).'}, {'measure': 'Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B', 'timeFrame': 'Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)', 'description': 'Criteria for PCI changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) \\>=300 milliseconds (msec) and increase of \\>=25% from baseline when baseline \\>200 msec or increase of \\>=50% when baseline less than or equal to (\\<=) 200 msec; the time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS interval) \\>=140 msec and increase of \\>=50% from baseline; the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT), corrected for heart rate (QTc) using the Fridericia formula (QTcF) of 450 to \\< 480 msec and \\>=480 msec, or an increase from baseline of 30 to \\<60 msec or \\>=60 msec.'}], 'secondaryOutcomes': [{'measure': 'GIR in Part B in Placebo Group', 'timeFrame': '6 weeks', 'description': 'Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.'}, {'measure': 'GIR in Part B in PF-05175157 200 mg BID Group', 'timeFrame': '6 weeks', 'description': 'Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.'}, {'measure': 'EGP in Part B in Placebo Group', 'timeFrame': '6 weeks', 'description': 'EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)'}, {'measure': 'EGP in Part B in PF-05175157 200 mg BID Group', 'timeFrame': '6 weeks', 'description': 'EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)'}, {'measure': 'Ra in Part B in Placebo Group', 'timeFrame': '6 weeks', 'description': 'Ra in fasting state and during insulin infusions (Step 1 and Step 2).'}, {'measure': 'Ra in Part B in PF-05175157 200 mg BID Group', 'timeFrame': '6 weeks', 'description': 'Ra in fasting state and during insulin infusions (Step 1 and Step 2).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Pharmacodynamics', 'Safety & Tolerability'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1731003&StudyName=A%206-Week%20Study%20Of%20PF-05175157%20In%20Type%202%20Diabetes%20Mellitus', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have been diagnosed with type 2 diabetes mellitus by a medical professional according to the American Diabetes Association guidelines.\n* Hemoglobin A1c of ≥7 and ≤10.0% in subjects who are metformin-naive or have not taken metformin for 2 months or Hemoglobin A1c of ≥6.5 and ≤9.5% in subjects who are metformin-naïve and are taking SU or DPP-IVi which is washed off or taking metformin and are willing to discontinue metformin in a 8-week washout period.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine (other than T2DM and hypothyroidism), gastrointestinal, cardiovascular, pulmonary, hepatic, psychiatric or neurologic disease.\n* A waist circumference which makes fitting imto the bore of the MR scanner impossible.\n\nSubjects with history of dry eye, known ocular or systemic disease that affect the sclera or cornea.'}, 'identificationModule': {'nctId': 'NCT01792635', 'briefTitle': 'A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 6-week Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Group Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral Pf-05175157 As Monotherapy In Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'B1731003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Part A (Pilot Study)'}, {'type': 'EXPERIMENTAL', 'label': 'Monotherapy (Part B)', 'interventionNames': ['Drug: PF-05175157', 'Drug: Placebo']}], 'interventions': [{'name': 'PF-05175157', 'type': 'DRUG', 'description': 'PF-05175157 will be administered at 200 mg twice a day for 43 days.', 'armGroupLabels': ['Monotherapy (Part B)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.', 'armGroupLabels': ['Monotherapy (Part B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research, Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}