{"protocolSection":{"identificationModule":{"nctId":"NCT02963766","orgStudyIdInfo":{"id":"14171"},"secondaryIdInfos":[{"id":"H9X-MC-GBGC","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2016-000361-22","type":"EUDRACT_NUMBER"},{"id":"2016","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2016"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes","officialTitle":"A Randomized, Double-Blind Study With an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Pediatric Patients With Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study)","acronym":"AWARD-PEDS"},"statusModule":{"statusVerifiedDate":"2022-06-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-12-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-06-12","type":"ACTUAL"},"completionDateStruct":{"date":"2022-01-12","type":"ACTUAL"},"studyFirstSubmitDate":"2016-11-10","studyFirstSubmitQcDate":"2016-11-10","studyFirstPostDateStruct":{"date":"2016-11-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2022-06-07","resultsFirstSubmitQcDate":"2022-06-07","resultsFirstPostDateStruct":{"date":"2022-07-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-06-07","lastUpdatePostDateStruct":{"date":"2022-07-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["Pediatrics"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":154,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo/0.75 milligram (mg) Dulaglutide","type":"EXPERIMENTAL","description":"Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE).","interventionNames":["Drug: Dulaglutide","Drug: Placebo"]},{"label":"0.75 mg Dulaglutide","type":"EXPERIMENTAL","description":"Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.","interventionNames":["Drug: Dulaglutide"]},{"label":"1.5 mg Dulaglutide","type":"EXPERIMENTAL","description":"Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.","interventionNames":["Drug: Dulaglutide"]}],"interventions":[{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["0.75 mg Dulaglutide","1.5 mg Dulaglutide","Placebo/0.75 milligram (mg) Dulaglutide"],"otherNames":["LY2189265"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo/0.75 milligram (mg) Dulaglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment\\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).","timeFrame":"Baseline, Week 26"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c (Individual Doses) at Week 26","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment\\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in Fasting Blood Glucose (FBG) at Week 26","description":"Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment\\*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group \\[ less than (\\<) 8%, greater than or equal to (\\>=) 8%).","timeFrame":"Baseline, Week 26"},{"measure":"Percentage of Participants With HbA1c ≤7.0%","description":"The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.","timeFrame":"Week 26"},{"measure":"Change From Baseline in Body Mass Index (BMI) at Week 26","description":"BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment\\*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (\\< 8%, \\>= 8%).","timeFrame":"Baseline, Week 26"},{"measure":"Percentage of Participants With Self-Reported Events of Hypoglycemia","description":"Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose \\<54mg/dL.","timeFrame":"Week 26"},{"measure":"Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia","description":"Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.","timeFrame":"Week 26"},{"measure":"Number of Participants With Adjudicated Pancreatitis","description":"The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Week 26"},{"measure":"Change From Baseline in Pancreatic Enzymes at Week 26","description":"Serum Amylase (total and pancreas-derived) and lipase concentrations were measured.","timeFrame":"Baseline, Week 26"},{"measure":"Number of Participants With Thyroid Treatment-Emergent Adverse Events","description":"Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.","timeFrame":"Week 26"},{"measure":"Change From Baseline in Serum Calcitonin at Week 26","description":"Change from Baseline in Serum Calcitonin was evaluated.","timeFrame":"Baseline, Week 26"},{"measure":"Percentage of Participants With Allergic, Hypersensitivity Reactions","description":"The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Week 26"},{"measure":"Percentage of Participants With Injection Site Reactions","description":"The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Week 26"},{"measure":"Number of Participants With Anti-Dulaglutide Antibodies","description":"Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.","timeFrame":"Baseline through Week 56"},{"measure":"Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)","description":"PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.","timeFrame":"Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit"},{"measure":"PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]","description":"PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State \\[AUC(0-168)ss\\] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.","timeFrame":"Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening.\n* Have HbA1c \\>6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between \\>6.5 % to ≤9%.\n* Have a BMI (body mass index) \\>85 percentile for age, gender and body weight ≥50 kilograms (110 pounds).\n\nExclusion Criteria:\n\n* Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.\n* A history of, or at risk for pancreatitis.\n* Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening.\n* A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg.\n* Active or treated cancer.\n* A blood disorder where an accurate HbA1c may not be obtainable.\n* A female of childbearing age, sexually active and not on birth control.\n* Pregnant or plan to be pregnant during the study, or breastfeeding.\n* Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin).\n* Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day.\n* Using prescription weight loss medications in the last 30 days, or plan to use.\n* Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.","healthyVolunteers":false,"sex":"ALL","minimumAge":"10 Years","maximumAge":"17 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - 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Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2."},{"pmid":"35658022","type":"DERIVED","citation":"Arslanian SA, Hannon T, Zeitler P, Chao LC, Boucher-Berry C, Barrientos-Perez M, Bismuth E, Dib S, Cho JI, Cox D; AWARD-PEDS Investigators. Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes. N Engl J Med. 2022 Aug 4;387(5):433-443. doi: 10.1056/NEJMoa2204601. Epub 2022 Jun 4."}],"seeAlsoLinks":[{"label":"A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS)","url":"https://trials.lillytrialguide.com/en-US/trial/5RwyJT8t9uI0ISG4U4SEu0"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"https://www.vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo/0.75 Milligram (mg) Dulaglutide","description":"Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the open Label Extension (OLE)."},{"id":"FG001","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE."},{"id":"FG002","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE."}],"periods":[{"title":"Double-Blind Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"51"},{"groupId":"FG002","numSubjects":"52"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"51"},{"groupId":"FG002","numSubjects":"52"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"47"},{"groupId":"FG001","numSubjects":"49"},{"groupId":"FG002","numSubjects":"50"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Parent or Guardian","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Open Label Extension 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Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1C","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered SC for 26 weeks."},{"id":"OG001","title":"Pooled Dulaglutide","description":"Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"100"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"0.24"},{"groupId":"OG001","value":"-0.7","spread":"0.16"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-1.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.8","ciUpperLimit":"-0.7"}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c (Individual Doses) at Week 26","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment\\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered SC for 26 weeks."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks."},{"id":"OG002","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"50"},{"groupId":"OG002","value":"50"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"0.24"},{"groupId":"OG001","value":"-0.5","spread":"0.22"},{"groupId":"OG002","value":"-1.0","spread":"0.22"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.002","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-1.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.7","ciUpperLimit":"-0.4"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-1.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.2","ciUpperLimit":"-0.9"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Blood Glucose (FBG) at Week 26","description":"Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. 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LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment\\*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (\\< 8%, \\>= 8%).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable BMI data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms/square meter (kg/m^2)","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered SC for 26 weeks."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks."},{"id":"OG002","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks."},{"id":"OG003","title":"Pooled Dulaglutide","description":"Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"52"},{"groupId":"OG003","value":"103"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.0","spread":"0.21"},{"groupId":"OG001","value":"-0.2","spread":"0.20"},{"groupId":"OG002","value":"-0.1","spread":"0.19"},{"groupId":"OG003","value":"-0.1","spread":"0.14"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.689","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.7","ciUpperLimit":"0.5"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.924","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-0.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.6","ciUpperLimit":"0.5"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.776","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.6","ciUpperLimit":"0.4"}]},{"type":"SECONDARY","title":"Percentage of Participants With Self-Reported Events of Hypoglycemia","description":"Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose \\<54mg/dL.","populationDescription":"All randomized participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered SC for 26 weeks."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks."},{"id":"OG002","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.96"},{"groupId":"OG001","value":"3.92"},{"groupId":"OG002","value":"3.85"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia","description":"Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.","populationDescription":"All randomized participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered SC for 26 weeks."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks."},{"id":"OG002","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks."},{"id":"OG003","title":"Pooled Dulaglutide","description":"Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"52"},{"groupId":"OG003","value":"103"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17.6"},{"groupId":"OG001","value":"3.9"},{"groupId":"OG002","value":"1.9"},{"groupId":"OG003","value":"2.9"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Adjudicated Pancreatitis","description":"The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"All randomized participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered SC for 26 weeks."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks."},{"id":"OG002","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks."},{"id":"OG003","title":"Pooled Dulaglutide","description":"Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"52"},{"groupId":"OG003","value":"103"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Pancreatic Enzymes at Week 26","description":"Serum Amylase (total and pancreas-derived) and lipase concentrations were measured.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable pancreatic enzymes data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units/Liter (U/L)","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered SC for 26 weeks."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks."},{"id":"OG002","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks."},{"id":"OG003","title":"Pooled Dulaglutide","description":"Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"52"},{"groupId":"OG003","value":"103"}]}],"classes":[{"title":"Serum Amylase","categories":[{"measurements":[{"groupId":"OG000","value":"0.09","spread":"17.36"},{"groupId":"OG001","value":"4.80","spread":"9.39"},{"groupId":"OG002","value":"6.50","spread":"8.91"},{"groupId":"OG003","value":"5.64","spread":"9.15"}]}]},{"title":"Serum Amylase, Pancreatic","categories":[{"measurements":[{"groupId":"OG000","value":"0.60","spread":"9.94"},{"groupId":"OG001","value":"1.77","spread":"4.72"},{"groupId":"OG002","value":"2.90","spread":"6.10"},{"groupId":"OG003","value":"2.32","spread":"5.45"}]}]},{"title":"Serum Lipase","categories":[{"measurements":[{"groupId":"OG000","value":"2.23","spread":"31.99"},{"groupId":"OG001","value":"4.37","spread":"8.28"},{"groupId":"OG002","value":"3.88","spread":"6.63"},{"groupId":"OG003","value":"4.12","spread":"7.47"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Thyroid Treatment-Emergent Adverse Events","description":"Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.","populationDescription":"All randomized participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Week 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