{"protocolSection":{"identificationModule":{"nctId":"NCT06109311","orgStudyIdInfo":{"id":"18567"},"secondaryIdInfos":[{"id":"J2A-MC-GZGW","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"U1111-1294-2797","type":"OTHER","domain":"UTN Number"},{"id":"2023-507280-18-00","type":"OTHER","domain":"EU Trial Number"},{"id":"2023","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2023"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor","officialTitle":"A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor","acronym":"ACHIEVE-5"},"statusModule":{"statusVerifiedDate":"2026-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-11-10","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-09-15","type":"ACTUAL"},"completionDateStruct":{"date":"2025-09-15","type":"ACTUAL"},"studyFirstSubmitDate":"2023-10-26","studyFirstSubmitQcDate":"2023-10-26","studyFirstPostDateStruct":{"date":"2023-10-31","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-09-10","resultsFirstSubmitQcDate":"2026-09-10","resultsFirstPostDateStruct":{"date":"2026-10-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-09-10","lastUpdatePostDateStruct":{"date":"2026-10-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits."},"conditionsModule":{"conditions":["Type 2 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":546,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received matching placebo administered orally once daily (QD) and insulin glargine therapy (100 Units per milliliter (U/mL)) administered subcutaneously (SC) QD, over a period of 40 weeks.","interventionNames":["Drug: Placebo"]},{"label":"3 mg Orforglipron QD","type":"EXPERIMENTAL","description":"Participants received oral orforglipron, initiated at 1 milligram (mg) and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks.","interventionNames":["Drug: Orforglipron"]},{"label":"12 mg Orforglipron QD","type":"EXPERIMENTAL","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks.","interventionNames":["Drug: Orforglipron"]},{"label":"36 mg Orforglipron QD","type":"EXPERIMENTAL","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks.","interventionNames":["Drug: Orforglipron"]}],"interventions":[{"type":"DRUG","name":"Orforglipron","description":"Administered orally.","armGroupLabels":["12 mg Orforglipron QD","3 mg Orforglipron QD","36 mg Orforglipron QD"],"otherNames":["LY3502970"]},{"type":"DRUG","name":"Placebo","description":"Administered orally.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time.\n\nValues represented under \"Least Squares (LS) Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \\[less than or equal to\\] 8.0%, \\> \\[greater than\\] 8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol)","description":"Percentage of participants with an HbA1c target value of less than (\\<) 7.0% (53 millimoles per mole \\[mmol/mol\\]) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","timeFrame":"Week 40"},{"measure":"Percentage of Participants With an HbA1c Target Value of < 6.5% (48 mmol/Mol)","description":"Percentage of Participants with an HbA1c target value of less than or equal to (≤) 6.5% (48 mmol/mol) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","timeFrame":"Week 40"},{"measure":"Change From Baseline in Fasting Serum Glucose (FSG)","description":"Values represented under \"Least Squares (LS) Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \\[less than or equal to\\] 8.0%, \\> \\[greater than\\] 8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percent Change From Baseline in Body Weight","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Change From Baseline in Body Weight (kg)","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percent Change From Baseline in Non-HDL (Non-high-density Lipoprotein) Cholesterol","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percent Change From Baseline in Triglycerides","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Change From Baseline in Systolic Blood Pressure (mmHg)","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Change From Baseline in Daily Insulin Glargine Dose (IU/Day)","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction","description":"Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","timeFrame":"Week 40"},{"measure":"Percentage of Participants With Greater Than or Equal to (≥) 10% Body Weight Reduction","description":"Percentage of participants with ≥10% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","timeFrame":"Week 40"},{"measure":"Percentage of Participants With Greater Than or Equal to (≥) 15% Body Weight Reduction","description":"Percentage of participants with ≥15% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","timeFrame":"Week 40"},{"measure":"Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores","description":"The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health \"now,\" whereas the remaining domains assess functioning \"in the past week.\" Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.","timeFrame":"Baseline, Week 40"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have Type 2 Diabetes (T2D)\n* Have HbA1c ≥7.0% \\[53 mmol/mol\\] to ≤10.5% \\[91 mmol/mol\\]\n* Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:\n\n  * insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or\n  * insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with\n  * metformin, or\n  * SGLT-2 inhibitor, or\n  * both metformin and SGLT-2 inhibitor.\n* Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.\n* Have a Body Mass Index (BMI) ≥23.0 kg/m\\^2 at baseline.\n\nExclusion Criteria:\n\n* Have New York Heart Association functional classification III-IV congestive heart failure.\n* Have had any of the following cardiovascular conditions within 60 days prior to baseline.\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke), or\n  * hospitalization for congestive heart failure.\n* Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease\n* Have had chronic or acute pancreatitis any time.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - 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Orforglipron Added to Titrated Insulin Glargine in Type 2 Diabetes: The ACHIEVE-5 Randomized Clinical Trial. JAMA. 2026 Aug 4;336(5):389-399. doi: 10.1001/jama.2026.9512."}],"seeAlsoLinks":[{"label":"A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor (ACHIEVE-5)","url":"https://trials.lilly.com/en-US/trial/432400"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual participant 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":"http://vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants received matching placebo administered orally once daily (QD) and insulin glargine therapy (100 Units per milliliter (U/mL)) administered subcutaneously (SC) QD, over a period of 40 weeks."},{"id":"FG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 milligram (mg) and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"FG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance 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Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"13"},{"groupId":"BG004","value":"53"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"82"},{"groupId":"BG001","value":"80"},{"groupId":"BG002","value":"77"},{"groupId":"BG003","value":"80"},{"groupId":"BG004","value":"319"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"23"}]},{"title":"Unknown or Not 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MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \\[less than or equal to\\] 8.0%, \\> \\[greater than\\] 8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications (\\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered subcutaneously (SC) QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.77","spread":"0.078"},{"groupId":"OG001","value":"-1.54","spread":"0.097"},{"groupId":"OG002","value":"-2.05","spread":"0.098"},{"groupId":"OG003","value":"-1.90","spread":"0.111"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Square (LS) Mean Difference (Net)","paramValue":"-0.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.01","ciUpperLimit":"-0.52"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"[LS Mean Difference (Net)","paramValue":"-1.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.52","ciUpperLimit":"-1.03"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Square (LS) Mean Difference (Net)","paramValue":"-1.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.39","ciUpperLimit":"-0.86"}]},{"type":"SECONDARY","title":"Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol)","description":"Percentage of participants with an HbA1c target value of less than (\\<) 7.0% (53 millimoles per mole \\[mmol/mol\\]) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.69"},{"groupId":"OG001","value":"60.74"},{"groupId":"OG002","value":"80.76"},{"groupId":"OG003","value":"69.16"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"37.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"26.67","ciUpperLimit":"47.42"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"57.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"47.48","ciUpperLimit":"66.66"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"45.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"35.34","ciUpperLimit":"55.60"}]},{"type":"SECONDARY","title":"Percentage of Participants With an HbA1c Target Value of < 6.5% (48 mmol/Mol)","description":"Percentage of Participants with an HbA1c target value of less than or equal to (≤) 6.5% (48 mmol/mol) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. 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Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.09"},{"groupId":"OG001","value":"45.94"},{"groupId":"OG002","value":"69.12"},{"groupId":"OG003","value":"60.07"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"34.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"25.66","ciUpperLimit":"44.04"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"58.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"48.69","ciUpperLimit":"67.36"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"48.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"39.51","ciUpperLimit":"58.44"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose (FSG)","description":"Values represented under \"Least Squares (LS) Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \\[less than or equal to\\] 8.0%, \\> \\[greater than\\] 8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications (\\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligrams per deciliter (mg/dL)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-35.3","spread":"2.36"},{"groupId":"OG001","value":"-40.5","spread":"2.84"},{"groupId":"OG002","value":"-48.0","spread":"2.74"},{"groupId":"OG003","value":"-44.5","spread":"2.69"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.161","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-5.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.4","ciUpperLimit":"2.1"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-12.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-19.7","ciUpperLimit":"-5.5"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.010","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-9.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.2","ciUpperLimit":"-2.2"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Body Weight","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"0.44"},{"groupId":"OG001","value":"-2.7","spread":"0.52"},{"groupId":"OG002","value":"-5.8","spread":"0.58"},{"groupId":"OG003","value":"-6.1","spread":"0.68"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-3.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.6","ciUpperLimit":"-2.0"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-6.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.8","ciUpperLimit":"-5.0"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-6.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.4","ciUpperLimit":"-5.2"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight (kg)","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Kilogram (kg)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"0.39"},{"groupId":"OG001","value":"-2.2","spread":"0.48"},{"groupId":"OG002","value":"-5.0","spread":"0.49"},{"groupId":"OG003","value":"-5.2","spread":"0.64"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-2.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.8","ciUpperLimit":"-1.4"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-5.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.7","ciUpperLimit":"-4.3"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-5.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.1","ciUpperLimit":"-4.2"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Non-HDL (Non-high-density Lipoprotein) Cholesterol","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications (\\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.13","spread":"2.679"},{"groupId":"OG001","value":"-3.90","spread":"2.346"},{"groupId":"OG002","value":"-7.64","spread":"2.597"},{"groupId":"OG003","value":"-7.81","spread":"2.450"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.437","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-2.80","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.53","ciUpperLimit":"4.43"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.081","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-6.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-13.46","ciUpperLimit":"0.85"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.066","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-6.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-13.45","ciUpperLimit":"0.46"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Triglycerides","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.73","spread":"3.398"},{"groupId":"OG001","value":"-4.80","spread":"3.149"},{"groupId":"OG002","value":"-17.45","spread":"3.040"},{"groupId":"OG003","value":"-14.71","spread":"3.144"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.987","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.18","ciUpperLimit":"9.93"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.005","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-13.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-21.61","ciUpperLimit":"-4.22"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.031","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-10.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-19.06","ciUpperLimit":"-0.98"}]},{"type":"SECONDARY","title":"Change From Baseline in Systolic Blood Pressure (mmHg)","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications (\\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"1.03"},{"groupId":"OG001","value":"-1.9","spread":"0.94"},{"groupId":"OG002","value":"-3.2","spread":"1.13"},{"groupId":"OG003","value":"-2.2","spread":"1.26"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.182","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-1.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.6","ciUpperLimit":"0.9"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.039","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-3.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.2","ciUpperLimit":"-0.2"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.179","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-2.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.4","ciUpperLimit":"1.0"}]},{"type":"SECONDARY","title":"Change From Baseline in Daily Insulin Glargine Dose (IU/Day)","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\]. Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications (\\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"International Units per day (IU/day)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.4","spread":"2.41"},{"groupId":"OG001","value":"8.9","spread":"1.57"},{"groupId":"OG002","value":"10.2","spread":"1.89"},{"groupId":"OG003","value":"8.4","spread":"2.28"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-12.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-18.2","ciUpperLimit":"-6.9"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-11.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.2","ciUpperLimit":"-5.2"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-13.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-19.5","ciUpperLimit":"-6.5"}]},{"type":"SECONDARY","title":"Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction","description":"Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.10"},{"groupId":"OG001","value":"35.42"},{"groupId":"OG002","value":"52.61"},{"groupId":"OG003","value":"50.56"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"19.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"9.12","ciUpperLimit":"29.53"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"36.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"25.97","ciUpperLimit":"47.05"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"34.46","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"23.62","ciUpperLimit":"45.29"}]},{"type":"SECONDARY","title":"Percentage of Participants With Greater Than or Equal to (≥) 10% Body Weight Reduction","description":"Percentage of participants with ≥10% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.24"},{"groupId":"OG001","value":"15.70"},{"groupId":"OG002","value":"23.34"},{"groupId":"OG003","value":"27.38"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"11.46","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.42","ciUpperLimit":"18.50"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"19.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"10.89","ciUpperLimit":"27.30"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"23.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"14.33","ciUpperLimit":"31.96"}]},{"type":"SECONDARY","title":"Percentage of Participants With Greater Than or Equal to (≥) 15% Body Weight Reduction","description":"Percentage of participants with ≥15% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications (\\> 14 days of use).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.52"},{"groupId":"OG001","value":"6.18"},{"groupId":"OG002","value":"9.90"},{"groupId":"OG003","value":"14.12"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.153","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"3.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.37","ciUpperLimit":"8.69"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.015","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"7.38","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.42","ciUpperLimit":"13.34"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"11.60","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.64","ciUpperLimit":"18.56"}]},{"type":"SECONDARY","title":"Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores","description":"The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health \"now,\" whereas the remaining domains assess functioning \"in the past week.\" Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.","populationDescription":"All randomized participants. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"t-score","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 12 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increasing every 4 weeks until reaching to a maintenance dose of 36 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"},{"groupId":"OG003","value":"136"}]}],"classes":[{"title":"Physical Component Score","categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"0.491"},{"groupId":"OG001","value":"0.47","spread":"0.496"},{"groupId":"OG002","value":"1.07","spread":"0.592"},{"groupId":"OG003","value":"0.35","spread":"0.572"}]}]},{"title":"Mental Component Score","categories":[{"measurements":[{"groupId":"OG000","value":"0.13","spread":"0.673"},{"groupId":"OG001","value":"1.11","spread":"0.693"},{"groupId":"OG002","value":"0.19","spread":"0.700"},{"groupId":"OG003","value":"0.98","spread":"0.514"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Physical Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an Analysis of Covariance (ANCOVA) with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","nonInferiorityType":"SUPERIORITY","pValue":"0.728","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"-0.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.57","ciUpperLimit":"1.10"},{"groupIds":["OG000","OG002"],"groupDescription":"Physical Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an Analysis of Covariance (ANCOVA) with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","nonInferiorityType":"SUPERIORITY","pValue":"0.622","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"0.37","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.10","ciUpperLimit":"1.84"},{"groupIds":["OG000","OG003"],"groupDescription":"Physical Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an Analysis of Covariance (ANCOVA) with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","nonInferiorityType":"SUPERIORITY","pValue":"0.628","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"-0.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.78","ciUpperLimit":"1.07"},{"groupIds":["OG000","OG001"],"groupDescription":"Mental Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","nonInferiorityType":"SUPERIORITY","pValue":"0.280","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"0.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.80","ciUpperLimit":"2.76"},{"groupIds":["OG000","OG002"],"groupDescription":"Mental Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","nonInferiorityType":"SUPERIORITY","pValue":"0.947","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.77","ciUpperLimit":"1.89"},{"groupIds":["OG000","OG003"],"groupDescription":"Mental Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and SGLT-2 inhibitor use at randomization \\[Yes or No\\].","nonInferiorityType":"SUPERIORITY","pValue":"0.303","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"0.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.77","ciUpperLimit":"2.48"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline to end of safety follow-up (up to 42 weeks)","description":"* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses.\n* Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received matching placebo administered orally QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 weeks.","deathsNumAffected":0,"deathsNumAtRisk":140,"seriousNumAffected":6,"seriousNumAtRisk":140,"otherNumAffected":111,"otherNumAtRisk":140},{"id":"EG001","title":"3 mg Orforglipron QD","description":"Participants received oral orforglipron, initiated at 1 mg and increased every 4 weeks until reaching to a maintenance dose of 3 mg QD and insulin glargine therapy 100 U/mL administered SC QD, over a period of 40 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28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":140},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":135}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":140},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":132},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":135}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":140},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":135}]},{"term":"Sepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":140},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":135}]},{"term":"Septic shock","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":140},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":135}]},{"term":"Rectal adenocarcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":140},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":135}]},{"term":"Salivary gland neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":140},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":132},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":135}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":140},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":135}]},{"term":"Hypoaesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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