{"protocolSection":{"identificationModule":{"nctId":"NCT05659537","orgStudyIdInfo":{"id":"18550"},"secondaryIdInfos":[{"id":"H9X-IN-GBGR","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India","officialTitle":"A 24-week Multicenter, Open-label, Single-arm Study to Evaluate Safety in Patients With Type 2 Diabetes Mellitus in India Treated With Dulaglutide"},"statusModule":{"statusVerifiedDate":"2025-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-12-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-01-16","type":"ACTUAL"},"completionDateStruct":{"date":"2024-01-16","type":"ACTUAL"},"studyFirstSubmitDate":"2022-12-15","studyFirstSubmitQcDate":"2022-12-20","studyFirstPostDateStruct":{"date":"2022-12-21","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-01-14","resultsFirstSubmitQcDate":"2025-01-14","resultsFirstPostDateStruct":{"date":"2025-02-05","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-02-06","lastUpdatePostDateStruct":{"date":"2025-02-20","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 evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"],"keywords":["Adult","GLP-1"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":212,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Dulaglutide","type":"EXPERIMENTAL","description":"* Participants received once-weekly (QW) subcutaneous (SC) dulaglutide injections for 24 weeks, starting with either 1.5 milligrams (mg) as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).\n* For participants reporting gastrointestinal adverse events (GI AEs) after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced.","interventionNames":["Drug: Dulaglutide"]}],"interventions":[{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["Dulaglutide"],"otherNames":["LY2189265"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths","description":"* An AE was any untoward medical occurrence in a participant who was administered an investigational product that did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE that occurred post-dose or was present prior to dosing and became more severe post-dose.\n* An SAE was any AE from the study that resulted in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that might not have been immediately life-threatening or resulted in death or hospitalization but might have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.\n* A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.","timeFrame":"Baseline through Follow-up (up to 28 weeks)"},{"measure":"Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events.","description":"Hypoglycemia events were defined as those with blood glucose (BG) levels less than (\\<) 70 milligrams per deciliter (mg/dL). Severe hypoglycemia events were defined as those with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. These events could be associated with sufficient neuroglycopenia to induce seizures or coma. The total number of participants who experienced hypoglycemia events, including severe hypoglycemia, was summarized cumulatively.","timeFrame":"Baseline through Follow-up (up to 28 weeks)"},{"measure":"Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24","description":"The percentage of participants who reported AEs and SAEs was calculated by dividing the total number of affected participants by the number of participants analyzed, then multiplying by 100. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.","timeFrame":"Baseline through Week 24"},{"measure":"Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24","description":"The number of participants who experienced at least one or more GI AEs of nausea, vomiting, and diarrhoea were summarized cumulatively. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.","timeFrame":"Baseline through Week 24"}],"secondaryOutcomes":[{"measure":"Mean Change in HbA1c From Baseline to Week 24","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The mean change in HbA1c levels was calculated using descriptive analysis, with baseline HbA1c as a covariate. Missing endpoints were addressed using the last observation carried forward (LOCF) method.","timeFrame":"Baseline, Week 24"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have a diagnosis of type 2 diabetes mellitus (T2DM) of at least 1-year duration currently treated with stable doses of oral antihyperglycemic medications with or without stable doses of basal or premix insulin for the last 3 months prior to screening\n* Have hemoglobin A1c (HbA1c) greater than or equal to (≥) 7.5 percent (%) and less than or equal to (≤) 11.5%, both inclusive, at screening\n* Have body mass index (BMI) ≥ 23 kilogram/square meter (kg/m²)\n\nExclusion Criteria:\n\n* A diagnosis of type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes, or specific type of diabetes other than T2DM\n* Been treated with antihyperglycemic medication like glucagon-like peptide receptor agonists (GLP-1 RA) or have a prior history of any contraindication to GLP-1 RA therapy within 3 months prior to screening or estimated glomerular filtration rate (eGFR) \\<15 milliliter/minute (ml/min)/1.73 square meter (m²)\n* Participants have known hypersensitivity or allergy to dulaglutide or its excipients\n* Participants are on systemic steroids for any period of more than 14 days\n* Participants have severe gastrointestinal (GI) disease, including severe gastroparesis\n* Participants have an active or untreated malignancy, except for successfully treated basal or squamous cell carcinoma","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 - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Medlink Hospital Opp Someshwara Jain Temple","city":"Ahmedabad","state":"Ambavadi","zip":"380015","country":"India","geoPoint":{"lat":23.02579,"lon":72.58727}},{"facility":"Life Care Hospital and Research Centre","city":"Bangalore","state":"Karnataka","zip":"560092","country":"India","geoPoint":{"lat":12.97194,"lon":77.59369}},{"facility":"Grant Medical Foundation - Ruby Hall Clinic","city":"Pune","state":"Maharashtra","zip":"411001","country":"India","geoPoint":{"lat":18.51957,"lon":73.85535}},{"facility":"Akshay Hospital","city":"Pune","state":"Maharashtra","zip":"411004","country":"India","geoPoint":{"lat":18.51957,"lon":73.85535}},{"facility":"Lifepoint Multispecialty Hsptl","city":"Wākad","state":"Pune","zip":"411057","country":"India","geoPoint":{"lat":20.13769,"lon":77.04481}},{"facility":"Kovai Diabetes Speciality Center and Hospital","city":"Coimbatore","state":"Tamil Nadu","zip":"641009","country":"India","geoPoint":{"lat":11.00555,"lon":76.96612}},{"facility":"Virinchi Hospital","city":"Hyderabad","state":"Telangana","zip":"50034","country":"India","geoPoint":{"lat":17.38405,"lon":78.45636}}]},"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":"http://vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Dulaglutide","description":"* Participants received once-weekly (QW) subcutaneous (SC) dulaglutide injections for 24 weeks, starting with either 1.5 milligrams (mg) as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).\n* For participants reporting gastrointestinal adverse events (GI AEs) after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"212"}]},{"type":"Received at Least One Dose of Dulaglutide (Safety Population)","achievements":[{"groupId":"FG000","comment":"Received at least one dose of 1.5 mg and 0.75 mg dulaglutide = 165; received at least one dose of 1.5 mg dulaglutide only = 21 and received at least one dose of 0.75 mg dulaglutide only = 14.","numSubjects":"200"}]},{"type":"Received at Least One Dulaglutide Dose and Had at Least One HbA1c Measurement Post-study Treatment","achievements":[{"groupId":"FG000","numSubjects":"189"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"185"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"27"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"13"}]},{"type":"Migration from the Study Site Such That Follow Up Visits are not Possible","reasons":[{"groupId":"FG000","numSubjects":"3"}]},{"type":"Participant had low absolute neutrophil count value","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Participant was suffering from anaemia","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment.","groups":[{"id":"BG000","title":"Dulaglutide","description":"* Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).\n* For participants reporting GI AEs after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"189"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.1","spread":"10.45"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"102"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"87"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"189"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"189"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"India","categories":[{"measurements":[{"groupId":"BG000","value":"189"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths","description":"* An AE was any untoward medical occurrence in a participant who was administered an investigational product that did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE that occurred post-dose or was present prior to dosing and became more severe post-dose.\n* An SAE was any AE from the study that resulted in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that might not have been immediately life-threatening or resulted in death or hospitalization but might have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.\n* A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.","populationDescription":"All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20 percent (%). However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20 %. Hence, outcomes are reported for the overall dulaglutide treatment group.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline through Follow-up (up to 28 weeks)","groups":[{"id":"OG000","title":"Dulaglutide","description":"* Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).\n* For participants reporting GI AEs after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"189"}]}],"classes":[{"title":"TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"106"}]}]},{"title":"SAEs","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Deaths","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events.","description":"Hypoglycemia events were defined as those with blood glucose (BG) levels less than (\\<) 70 milligrams per deciliter (mg/dL). Severe hypoglycemia events were defined as those with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. These events could be associated with sufficient neuroglycopenia to induce seizures or coma. The total number of participants who experienced hypoglycemia events, including severe hypoglycemia, was summarized cumulatively.","populationDescription":"All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20%. However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20%. Hence, outcomes are reported for the overall dulaglutide treatment group.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline through Follow-up (up to 28 weeks)","groups":[{"id":"OG000","title":"Dulaglutide","description":"* Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).\n* For participants reporting GI AEs after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"189"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}]}]},{"type":"PRIMARY","title":"Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24","description":"The percentage of participants who reported AEs and SAEs was calculated by dividing the total number of affected participants by the number of participants analyzed, then multiplying by 100. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.","populationDescription":"All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20%. However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20%. Hence, outcomes are reported for the overall dulaglutide treatment group.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through Week 24","groups":[{"id":"OG000","title":"Dulaglutide","description":"* Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).\n* For participants reporting GI AEs after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"189"}]}],"classes":[{"title":"AEs","categories":[{"measurements":[{"groupId":"OG000","value":"51.9"}]}]},{"title":"SAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0.5"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24","description":"The number of participants who experienced at least one or more GI AEs of nausea, vomiting, and diarrhoea were summarized cumulatively. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.","populationDescription":"All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20%. However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20%. Hence, outcomes are reported for the overall dulaglutide treatment group.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline through Week 24","groups":[{"id":"OG000","title":"Dulaglutide","description":"* Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).\n* For participants reporting GI AEs after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"189"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"48"}]}]}]},{"type":"SECONDARY","title":"Mean Change in HbA1c From Baseline to Week 24","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The mean change in HbA1c levels was calculated using descriptive analysis, with baseline HbA1c as a covariate. Missing endpoints were addressed using the last observation carried forward (LOCF) method.","populationDescription":"All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20%. However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20%. Hence, outcomes are reported for the overall dulaglutide treatment group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Dulaglutide","description":"* Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).\n* For participants reporting GI AEs after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"189"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.41","spread":"1.422"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"From baseline until safety follow-up (up to 28 weeks)","description":"All participants who had received at least one dose of dulaglutide.","eventGroups":[{"id":"EG000","title":"1.5 mg/0.75 mg Dulaglutide (Both Doses)","description":"Participants in this arm received SC injections of both 1.5 mg and 0.75 mg dulaglutide QW doses at different points during the 24-week treatment period.","deathsNumAffected":0,"deathsNumAtRisk":165,"seriousNumAffected":1,"seriousNumAtRisk":165,"otherNumAffected":100,"otherNumAtRisk":165},{"id":"EG001","title":"1.5 mg Dulaglutide Only","description":"Participants in this arm received SC injections of only 1.5 mg of dulaglutide QW over a 24-week treatment period.","deathsNumAffected":0,"deathsNumAtRisk":21,"seriousNumAffected":0,"seriousNumAtRisk":21,"otherNumAffected":8,"otherNumAtRisk":21},{"id":"EG002","title":"0.75 mg Dulaglutide Only","description":"Participants in this arm received SC injections of only 0.75 mg of dulaglutide QW over a 24-week treatment period.","deathsNumAffected":0,"deathsNumAtRisk":14,"seriousNumAffected":0,"seriousNumAtRisk":14,"otherNumAffected":6,"otherNumAtRisk":14}],"seriousEvents":[{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":165},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":14}]}],"otherEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":165},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":165},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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