{"protocolSection":{"identificationModule":{"nctId":"NCT04552470","orgStudyIdInfo":{"id":"C3421015"},"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus","officialTitle":"AN 8-WEEK PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF TWICE DAILY PF-06882961 ADMINISTRATION IN JAPANESE ADULTS WITH TYPE 2 DIABETES MELLITUS"},"statusModule":{"statusVerifiedDate":"2022-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-10-26","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-03-25","type":"ACTUAL"},"completionDateStruct":{"date":"2021-03-25","type":"ACTUAL"},"studyFirstSubmitDate":"2020-09-11","studyFirstSubmitQcDate":"2020-09-11","studyFirstPostDateStruct":{"date":"2020-09-17","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-12-14","resultsFirstSubmitQcDate":"2022-03-10","resultsFirstPostDateStruct":{"date":"2022-03-11","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-03-10","lastUpdatePostDateStruct":{"date":"2022-03-11","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled, twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM inadequately controlled on diet and exercise alone."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":37,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"PF-06882961 40 mg","type":"EXPERIMENTAL","description":"Participants will be titrated up to 2 weeks to reach desired dose level","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 80 mg","type":"EXPERIMENTAL","description":"Participants will be titrated up to 4 weeks to reach desired dose level","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 120 mg","type":"EXPERIMENTAL","description":"Participants will be titrated up to 6 weeks to reach desired dose level","interventionNames":["Drug: PF-06882961"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"3 matching placebo tablets taken twice a day (BID)","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"PF-06882961","description":"Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.","armGroupLabels":["PF-06882961 120 mg","PF-06882961 40 mg","PF-06882961 80 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)","description":"An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment emergent AEs were events between first dose of study drug and approximately 4 weeks after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.","timeFrame":"Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)"},{"measure":"Number of Participants With Clinical Laboratory Abnormalities","description":"Leukocytes (10\\^9/liter \\[L\\]) bilirubin (micromol/L), glucose (millimoles \\[mmol\\]/L), triacylglycerol lipase (microkatals \\[microkat\\]/L): greater than (\\>) 1.5\\*upper limit normal (ULN); activated partial thromboplastin time (s): 1.1\\*ULN; HDL cholesterol (mmol/L), thyroid stimulating hormone (TSH) (milliunits \\[mU\\]/L): less than (\\<) 0.8\\*lower limit normal (LLN); LDL cholesterol (mmol/L), urate (mmol/L): \\>1.2\\*ULN; triglycerides: \\>1.3\\*ULN; aspartate aminotransferase (microkat/L), alanine aminotransferase (microkat/L), gamma glutamyl transferase (microkat/L): \\>3.0\\*ULN; cholesterol (mmol/L): \\>1.3\\*ULN; urine glucose, ketones urine protein, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase: greater than or equal to (\\>=) 1; granular casts, hyaline casts: \\>1.","timeFrame":"Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)"},{"measure":"Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline","description":"Supine systolic blood pressure (SBP) measured in millimeter of mercury (mmHg) had following categories: minimum of absolute SBP \\<90 mmHg, maximum of SBP \\>=30 mmHg decrease from baseline and maximum of SBP \\>=30 mmHg increase from baseline. Supine diastolic blood pressure (DBP) measured in mmHg had following categories: minimum of absolute DBP \\<50 mmHg, maximum of DBP \\>20 mmHg decrease from baseline and maximum of DBP \\>=20 mmHg increase from baseline. Supine pulse rate measured in beats per minute (BPM) had following categories: minimum of absolute supine pulse rate \\<40 BPM and maximum of absolute supine pulse rate \\>120 BPM. Baseline was defined as the time-matched value from the average of the triplicate recordings on Day -1.","timeFrame":"Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)"},{"measure":"Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline","description":"PR interval had following categories: maximum absolute PR interval \\>=300 milliseconds (msec); when baseline PR interval \\>200 msec and maximum increase from baseline in PR interval \\>=25 percent; when baseline PR interval less than or equal to (\\<=) 200 msec and maximum increase from baseline in PR interval \\>=50 percent. QRS interval had following categories: maximum absolute QRS interval \\>=140 msec; maximum increase from baseline in QRS interval \\>=50 percent. QTC interval with Frederica's correction (QTCF) had following categories: absolute QTCF interval \\>450 msec to \\<=480 msec; absolute QTCF interval \\>480 msec to \\<=500 msec; absolute QTCF interval \\>500 msec; QTCF interval increase from baseline \\>=30 msec to \\<=60 msec; QTCF interval increase from baseline \\>60 msec.","timeFrame":"Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)"}],"secondaryOutcomes":[{"measure":"Area Under the Plasma Concentration-time Profile From Zero to Time 24 Hours (AUC24) of PF-06882961","description":"AUC24= Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).","timeFrame":"Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1 and 56"},{"measure":"Maximum Plasma Concentration (Cmax) Observed of PF-06882961","timeFrame":"Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56"},{"measure":"Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06882961","timeFrame":"Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56"},{"measure":"Terminal Phase Half-Life (t1/2) of PF-06882961","description":"t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.","timeFrame":"Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients with T2DM who are treated with diet and exercise\n* HbA1c greater than or equal to 7% and less than or equal to 10.5%\n* Total body weight \\>50 kg (110 lb) with BMI 22.5 to 45.4 kg/m\\^2\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption\n* Diagnosis of Type 1 diabetes\n* History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening\n* Any malignancy not considered cured\n* Personal or family history of MTC or MEN2, or participants with suspected MTC\n* Acute pancreatitis or history of chronic pancreatitis\n* Symptomatic gallbladder disease\n* Known medical history of active proliferative retinopathy and/or macular edema\n* Known history of HIV, hepatitis B, hepatitis C or syphilis\n* Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)\n* Clinically relevant ECG abnormalities\n* Positive urine drug test","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"P-one clinic, Keikokai medical corporation","city":"Hachiōji","state":"Tokyo","zip":"192-0071","country":"Japan","geoPoint":{"lat":35.65583,"lon":139.32389}}]},"referencesModule":{"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://pmiform.com/clinical-trial-info-request?StudyID=C3421015"}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"65 participants signed the inform consent form (ICF). 28 participants were screen failures who did not meet criteria and were not enrolled. 37 participants enrolled into the study and assigned to a study treatment.","groups":[{"id":"FG000","title":"Placebo","description":"Participants with type 2 diabetes mellitus (T2DM) were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks."},{"id":"FG001","title":"PF-06882961 40 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"FG002","title":"PF-06882961 80 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"FG003","title":"PF-06882961 120 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"9"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"9"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.","groups":[{"id":"BG000","title":"Placebo","description":"Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks."},{"id":"BG001","title":"PF-06882961 40 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"BG002","title":"PF-06882961 80 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"BG003","title":"PF-06882961 120 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"37"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.6","spread":"8.75"},{"groupId":"BG001","value":"55.9","spread":"10.04"},{"groupId":"BG002","value":"58.0","spread":"6.69"},{"groupId":"BG003","value":"50.7","spread":"7.50"},{"groupId":"BG004","value":"55.8","spread":"8.62"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"5"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"32"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"37"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"37"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)","description":"An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment emergent AEs were events between first dose of study drug and approximately 4 weeks after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.","populationDescription":"Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)","groups":[{"id":"OG000","title":"Placebo","description":"Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG001","title":"PF-06882961 40 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG002","title":"PF-06882961 80 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG003","title":"PF-06882961 120 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"9"}]}],"classes":[{"title":"Participants with AEs","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"9"}]}]},{"title":"Participants with SAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Clinical Laboratory Abnormalities","description":"Leukocytes (10\\^9/liter \\[L\\]) bilirubin (micromol/L), glucose (millimoles \\[mmol\\]/L), triacylglycerol lipase (microkatals \\[microkat\\]/L): greater than (\\>) 1.5\\*upper limit normal (ULN); activated partial thromboplastin time (s): 1.1\\*ULN; HDL cholesterol (mmol/L), thyroid stimulating hormone (TSH) (milliunits \\[mU\\]/L): less than (\\<) 0.8\\*lower limit normal (LLN); LDL cholesterol (mmol/L), urate (mmol/L): \\>1.2\\*ULN; triglycerides: \\>1.3\\*ULN; aspartate aminotransferase (microkat/L), alanine aminotransferase (microkat/L), gamma glutamyl transferase (microkat/L): \\>3.0\\*ULN; cholesterol (mmol/L): \\>1.3\\*ULN; urine glucose, ketones urine protein, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase: greater than or equal to (\\>=) 1; granular casts, hyaline casts: \\>1.","populationDescription":"Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)","groups":[{"id":"OG000","title":"Placebo","description":"Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG001","title":"PF-06882961 40 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG002","title":"PF-06882961 80 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG003","title":"PF-06882961 120 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"9"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline","description":"Supine systolic blood pressure (SBP) measured in millimeter of mercury (mmHg) had following categories: minimum of absolute SBP \\<90 mmHg, maximum of SBP \\>=30 mmHg decrease from baseline and maximum of SBP \\>=30 mmHg increase from baseline. Supine diastolic blood pressure (DBP) measured in mmHg had following categories: minimum of absolute DBP \\<50 mmHg, maximum of DBP \\>20 mmHg decrease from baseline and maximum of DBP \\>=20 mmHg increase from baseline. Supine pulse rate measured in beats per minute (BPM) had following categories: minimum of absolute supine pulse rate \\<40 BPM and maximum of absolute supine pulse rate \\>120 BPM. Baseline was defined as the time-matched value from the average of the triplicate recordings on Day -1.","populationDescription":"Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)","groups":[{"id":"OG000","title":"Placebo","description":"Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG001","title":"PF-06882961 40 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG002","title":"PF-06882961 80 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG003","title":"PF-06882961 120 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"9"}]}],"classes":[{"title":"Minimum of absolute SBP <90 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Maximum of SBP >=30 mmHg decrease","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Maximum of SBP >=30 mmHg increase","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"}]}]},{"title":"Minimum of absolute DBP <50 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Maximum of DBP >=20 mmHg decrease","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Maximum of DBP >=20 mmHg increase","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"}]}]},{"title":"Minimum of absolute pulse rate <40 BPM","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Maximum of absolute pulse rate >120 BPM","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline","description":"PR interval had following categories: maximum absolute PR interval \\>=300 milliseconds (msec); when baseline PR interval \\>200 msec and maximum increase from baseline in PR interval \\>=25 percent; when baseline PR interval less than or equal to (\\<=) 200 msec and maximum increase from baseline in PR interval \\>=50 percent. QRS interval had following categories: maximum absolute QRS interval \\>=140 msec; maximum increase from baseline in QRS interval \\>=50 percent. QTC interval with Frederica's correction (QTCF) had following categories: absolute QTCF interval \\>450 msec to \\<=480 msec; absolute QTCF interval \\>480 msec to \\<=500 msec; absolute QTCF interval \\>500 msec; QTCF interval increase from baseline \\>=30 msec to \\<=60 msec; QTCF interval increase from baseline \\>60 msec.","populationDescription":"Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)","groups":[{"id":"OG000","title":"Placebo","description":"Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG001","title":"PF-06882961 40 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG002","title":"PF-06882961 80 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG003","title":"PF-06882961 120 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"9"}]}],"classes":[{"title":"Maximum absolute PR >=300 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Baseline PR >200 msec and maximum increase in PR >=25%","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Baseline PR <=200 msec and maximum increase in PR >=50%","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Maximum absolute QRS >=140 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Maximum increase in QRS >=50%","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Absolute QTCF interval >450 msec to <=480 msec","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}]},{"title":"Absolute QTCF interval >480 msec to <=500 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Absolute QTCF >500 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"QTCF increase >=30 msec to <=60 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"QTCF increase >60 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Area Under the Plasma Concentration-time Profile From Zero to Time 24 Hours (AUC24) of PF-06882961","description":"AUC24= Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).","populationDescription":"Pharmacokinetic (PK) parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports AUC24 of PF-06882961, hence there is no data collected and analyzed for reporting arm \"Placebo\". Here \"Number Analyzed\" signifies participants evaluable at specified time points.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Nanogram*hour per milliliter","timeFrame":"Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1 and 56","groups":[{"id":"OG000","title":"PF-06882961 40 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG001","title":"PF-06882961 80 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG002","title":"PF-06882961 120 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"classes":[{"title":"Day 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"414.4","spread":"58"},{"groupId":"OG001","value":"500.3","spread":"58"},{"groupId":"OG002","value":"484.5","spread":"73"}]}]},{"title":"Day 56","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"7"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2424","spread":"45"},{"groupId":"OG001","value":"4691","spread":"75"},{"groupId":"OG002","value":"6953","spread":"148"}]}]}]},{"type":"SECONDARY","title":"Maximum Plasma Concentration (Cmax) Observed of PF-06882961","populationDescription":"PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports Cmax of PF-06882961, hence there is no data collected and analyzed for reporting arm \"Placebo\". Here \"Number Analyzed\" signifies participants evaluable at specified time points.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Nanogram per milliliter","timeFrame":"Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56","groups":[{"id":"OG000","title":"PF-06882961 40 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG001","title":"PF-06882961 80 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG002","title":"PF-06882961 120 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"classes":[{"title":"Day 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"32.83","spread":"55"},{"groupId":"OG001","value":"45.89","spread":"52"},{"groupId":"OG002","value":"39.35","spread":"80"}]}]},{"title":"Day 56","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"7"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"206.1","spread":"54"},{"groupId":"OG001","value":"352.2","spread":"75"},{"groupId":"OG002","value":"551.7","spread":"153"}]}]}]},{"type":"SECONDARY","title":"Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06882961","populationDescription":"PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports Tmax of PF-06882961, hence there is no data collected and analyzed for reporting arm \"Placebo\". Here \"Number Analyzed\" signifies participants evaluable at specified time points.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Hours","timeFrame":"Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56","groups":[{"id":"OG000","title":"PF-06882961 40 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG001","title":"PF-06882961 80 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG002","title":"PF-06882961 120 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"classes":[{"title":"Day 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"12.0","lowerLimit":"2.00","upperLimit":"23.8"},{"groupId":"OG001","value":"12.0","lowerLimit":"1.00","upperLimit":"12.0"},{"groupId":"OG002","value":"12.0","lowerLimit":"1.00","upperLimit":"14.0"}]}]},{"title":"Day 56","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"7"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"12.0","lowerLimit":"6.00","upperLimit":"13.8"},{"groupId":"OG001","value":"12.9","lowerLimit":"2.00","upperLimit":"36.0"},{"groupId":"OG002","value":"12.0","lowerLimit":"0.000","upperLimit":"13.8"}]}]}]},{"type":"SECONDARY","title":"Terminal Phase Half-Life (t1/2) of PF-06882961","description":"t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.","populationDescription":"PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports t1/2 of PF-06882961, hence there is no data collected and analyzed for reporting arm \"Placebo\".","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Hours","timeFrame":"Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56","groups":[{"id":"OG000","title":"PF-06882961 40 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG001","title":"PF-06882961 80 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks."},{"id":"OG002","title":"PF-06882961 120 mg","description":"Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.373","spread":"1.7404"},{"groupId":"OG001","value":"5.543","spread":"0.30827"},{"groupId":"OG002","value":"5.300","spread":"0.80594"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)","description":"Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. 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Post treatment participants were followed approximately for 4 weeks.","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":9,"otherNumAtRisk":9}],"otherEvents":[{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":4,"numAtRisk":10},{"groupId":"EG002","numAffected":4,"numAtRisk":9},{"groupId":"EG003","numAffected":5,"numAtRisk":9}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":9}]},{"term":"Dental caries","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":1,"numAtRisk":9}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":9},{"groupId":"EG003","numAffected":1,"numAtRisk":9}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":6,"numAtRisk":10},{"groupId":"EG002","numAffected":8,"numAtRisk":9},{"groupId":"EG003","numAffected":4,"numAtRisk":9}]},{"term":"Stomatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":9}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":5,"numAtRisk":10},{"groupId":"EG002","numAffected":6,"numAtRisk":9},{"groupId":"EG003","numAffected":5,"numAtRisk":9}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":9}]},{"term":"Hordeolum","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":9}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":1,"numAtRisk":9}]},{"term":"Alanine aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":9}]},{"term":"Aspartate aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":9}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":9}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":9},{"groupId":"EG003","numAffected":1,"numAtRisk":9}]},{"term":"Hypoglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":9}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":2,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":9}]},{"term":"Presyncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v.23.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":1,"numAtRisk":9}]},{"term":"Dermatitis 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