{"protocolSection":{"identificationModule":{"nctId":"NCT02072096","orgStudyIdInfo":{"id":"14842"},"secondaryIdInfos":[{"id":"F3Z-MC-IOQL","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2013-001473-24","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)","officialTitle":"An Individualized treatMent aPproach for oldER patIents: A Randomized, Controlled stUdy in Type 2 Diabetes Mellitus (IMPERIUM)","acronym":"IMPERIUM"},"statusModule":{"statusVerifiedDate":"2019-09","overallStatus":"TERMINATED","whyStopped":"The trial was terminated per protocol because of lack of feasibility.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-02"},"primaryCompletionDateStruct":{"date":"2015-10","type":"ACTUAL"},"completionDateStruct":{"date":"2015-10","type":"ACTUAL"},"studyFirstSubmitDate":"2014-02-24","studyFirstSubmitQcDate":"2014-02-24","studyFirstPostDateStruct":{"date":"2014-02-26","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-10-04","resultsFirstSubmitQcDate":"2016-10-04","resultsFirstPostDateStruct":{"date":"2016-11-23","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-09-25","lastUpdatePostDateStruct":{"date":"2019-10-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to compare the benefits and risks associated with the use of 2 treatment strategies to lower blood sugar in participants aged 65 and older with T2DM. One strategy is based on the use of oral and injectable medications that only reduce blood sugar (glucose) when it is high. The other strategy is based on non-glucose dependent agents. The trial will last up to 72 weeks for each participant."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":192,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Strategy A (Glucose-Dependent)","type":"EXPERIMENTAL","description":"Participants may receive oral and injectable (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) therapies that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.","interventionNames":["Drug: Metformin","Drug: Pioglitazone","Drug: Acarbose","Drug: Linagliptin","Drug: Sitagliptin","Drug: Liraglutide","Drug: Exenatide once weekly (QW)","Drug: Exenatide twice daily (BID)"]},{"label":"Strategy B (Reference)","type":"ACTIVE_COMPARATOR","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according treatment algorithm. Treatment may last up to 72 weeks.","interventionNames":["Drug: Glimepiride","Drug: Metformin","Drug: Pioglitazone","Drug: Acarbose","Drug: Linagliptin","Drug: Sitagliptin","Drug: Insulin Glargine"]}],"interventions":[{"type":"DRUG","name":"Glimepiride","description":"Administered orally","armGroupLabels":["Strategy B (Reference)"]},{"type":"DRUG","name":"Metformin","description":"Administered orally","armGroupLabels":["Strategy A (Glucose-Dependent)","Strategy B (Reference)"]},{"type":"DRUG","name":"Pioglitazone","description":"Administered orally","armGroupLabels":["Strategy A (Glucose-Dependent)","Strategy B (Reference)"]},{"type":"DRUG","name":"Acarbose","description":"Administered orally","armGroupLabels":["Strategy A (Glucose-Dependent)","Strategy B (Reference)"]},{"type":"DRUG","name":"Linagliptin","description":"Administered orally","armGroupLabels":["Strategy A (Glucose-Dependent)","Strategy B (Reference)"]},{"type":"DRUG","name":"Sitagliptin","description":"Administered orally","armGroupLabels":["Strategy A (Glucose-Dependent)","Strategy B (Reference)"]},{"type":"DRUG","name":"Liraglutide","description":"Administered subcutaneously (SC)","armGroupLabels":["Strategy A (Glucose-Dependent)"]},{"type":"DRUG","name":"Insulin Glargine","description":"Administered SC","armGroupLabels":["Strategy B (Reference)"]},{"type":"DRUG","name":"Exenatide once weekly (QW)","description":"Administered SC","armGroupLabels":["Strategy A (Glucose-Dependent)"]},{"type":"DRUG","name":"Exenatide twice daily (BID)","description":"Administered SC","armGroupLabels":["Strategy A (Glucose-Dependent)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia","description":"Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c \\> upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c \\> upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose \\<3.0 mmol/L. Success is defined as lacking of failure.","timeFrame":"Baseline to last participant visit (up to 72 weeks)"}],"secondaryOutcomes":[{"measure":"Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy","timeFrame":"Baseline to last participant visit (up to 72 weeks)"},{"measure":"Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia","timeFrame":"Baseline to last participant visit (up to 72 weeks)"},{"measure":"Change From Baseline of Urinary Albumin to Creatinine Ratio","description":"The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease.","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Body Mass Index (BMI)","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)","description":"The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease.","timeFrame":"Baseline, Week 72"}],"otherOutcomes":[{"measure":"Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Mini-mental State Examination (MMSE) Score","timeFrame":"Baseline, Week 72"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have T2DM based on a history and clinical impression that is consistent with the World Health Organization (WHO) Classification of Diabetes\n* Have a Clinical Frailty Scale (CFS) score of 4 or above or Total Illness Burden Index (TIBI) score of 5 or above as assessed at screening\n* Have an A1c \\>7.3% and \\<10.9% at study entry and are not achieving desired glycemic control as evidenced by A1c measurement at least 0.4% higher than individualized treatment target set at screening.\n* Have been treated for at least 3 months prior to the study entry with any of the following treatment options:\n\n  * Diet/exercise only (only if they have known contraindications to metformin treatment)\n  * Any dose of sulfonylurea\n  * Effective or maximally-tolerated doses of metformin, dipeptidyl-peptidase-4 (DPP-4) inhibitor, thiazolidinedione, or acarbose used in monotherapy or in dual combination. The following doses are considered to be effective:\n\n    * at least 1500 mg of metformin per day\n    * At least 30 mg of pioglitazone per day\n    * At least 4 mg of rosiglitazone per day\n    * At least 75 mg of acarbose per day\n    * Any marketed dose of DPP-4 inhibitor\n\nExclusion Criteria:\n\n* Are currently enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study\n* Have participated, within the last 60 days in a clinical trial involving an investigational product other than the investigational product used in this study. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed\n* Have previously completed or withdrawn from this study. This exclusion criterion does not apply to participants who are rescreened prior to randomization\n* At study entry, have contraindications to sulfonylurea, insulin, or GLP-1 RA\n* Have a history of pancreatitis, a personal or family history of medullary thyroid carcinoma, or have Multiple Endocrine Neoplasia syndrome type 2\n* Have taken any injectable glucose-lowering agent, miglitol, meglitinide, Sodium/Glucose cotransporter-2 inhibitor, or other antihyperglycemia treatment that is not listed in the fourth inclusion criterion for more than 10 days within 3 months prior to the study entry\n* In the opinion of investigator should have an individualized A1c target set at 8% or higher\n* Have a body mass index (BMI) greater than 45 kg/m\\^2\n* Have had more than 1 episode of severe hypoglycemia within 24 weeks prior to the study\n* Have cardiac disease with functional status that is Class III or IV according to the New York Heart Association Cardiac Disease Classification\n* Have an estimated glomerular filtration rate (eGFR) \\<30 milliliter/minute/1.73 m\\^2 (mL/min/1.73 m\\^2) or advanced renal disease including history of renal transplantation or currently receiving renal dialysis\n* Have obvious clinical signs or symptoms or laboratory evidence of liver disease (alanine aminotransferase \\[ALT\\] or aspartate aminotransferase \\[AST\\] \\> 2.5 times the upper limit of the reference range)\n* Receive current therapy for a malignancy, other than basal-cell or squamous-cell skin cancer\n* Received systemic glucocorticoids within the 3 months prior to entry for more than 14 consecutive days\n* Have any other condition that precludes the participant from following and completing the study","healthyVolunteers":false,"sex":"ALL","minimumAge":"65 Years","stdAges":["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":"Suncoast Research Group, LLC","city":"Miami","state":"Florida","zip":"33135","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"New Horizon Research Center","city":"Miami","state":"Florida","zip":"33175","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Suncoast Clinical Research","city":"New Port Richey","state":"Florida","zip":"34652","country":"United States","geoPoint":{"lat":28.24418,"lon":-82.71927}},{"facility":"Florida Hospital","city":"Orlando","state":"Florida","zip":"32804","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Athens Primary Care","city":"Athens","state":"Georgia","zip":"30606","country":"United States","geoPoint":{"lat":33.96095,"lon":-83.37794}},{"facility":"Herman Clinical Research, LLC","city":"Suwanee","state":"Georgia","zip":"30024","country":"United States","geoPoint":{"lat":34.05149,"lon":-84.0713}},{"facility":"Rocky Mountain Diabetes and Osteoporosis Center","city":"Idaho Falls","state":"Idaho","zip":"83404","country":"United States","geoPoint":{"lat":43.46658,"lon":-112.03414}},{"facility":"Iderc, P.L.C.","city":"Des Moines","state":"Iowa","zip":"50314","country":"United States","geoPoint":{"lat":41.60054,"lon":-93.60911}},{"facility":"Cotton O'Neil Clinic","city":"Topeka","state":"Kansas","zip":"66606","country":"United States","geoPoint":{"lat":39.04833,"lon":-95.67804}},{"facility":"Mercy Health Research","city":"St Louis","state":"Missouri","zip":"63141","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"Southern New Hampshire Diabetes and Endocrinology","city":"Nashua","state":"New Hampshire","zip":"03063","country":"United States","geoPoint":{"lat":42.76537,"lon":-71.46757}},{"facility":"Heritage Valley Medical Group, Inc.","city":"Beaver","state":"Pennsylvania","zip":"15009","country":"United States","geoPoint":{"lat":40.69534,"lon":-80.30478}},{"facility":"Family Medical Associates","city":"Levittown","state":"Pennsylvania","zip":"19056","country":"United States","geoPoint":{"lat":40.15511,"lon":-74.82877}},{"facility":"Carolina Health Specialists","city":"Myrtle Beach","state":"South Carolina","zip":"29572","country":"United States","geoPoint":{"lat":33.68906,"lon":-78.88669}},{"facility":"Dallas Diabetes Endocrine Center","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Rockwood Clinic Research Center","city":"Spokane","state":"Washington","zip":"99202","country":"United States","geoPoint":{"lat":47.65966,"lon":-117.42908}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Saint Stefan Ob Stainz","zip":"A-8511","country":"Austria"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Salzburg","zip":"5026","country":"Austria","geoPoint":{"lat":47.79941,"lon":13.04399}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Vienna","zip":"A 1210","country":"Austria","geoPoint":{"lat":48.20849,"lon":16.37208}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Vienna","zip":"A-1060","country":"Austria","geoPoint":{"lat":48.20849,"lon":16.37208}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Berlin","zip":"10409","country":"Germany","geoPoint":{"lat":52.52437,"lon":13.41053}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Dortmund","zip":"44137","country":"Germany","geoPoint":{"lat":51.51494,"lon":7.466}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hamburg","zip":"22607","country":"Germany","geoPoint":{"lat":53.55073,"lon":9.99302}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Mainz","zip":"55116","country":"Germany","geoPoint":{"lat":49.98185,"lon":8.28008}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Münster","zip":"48145","country":"Germany","geoPoint":{"lat":51.96236,"lon":7.62571}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Neuwied","zip":"56564","country":"Germany","geoPoint":{"lat":50.4336,"lon":7.47057}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Stuttgart","zip":"70378","country":"Germany","geoPoint":{"lat":48.78232,"lon":9.17702}},{"facility":"Manati Medical Center","city":"Manati","zip":"00674","country":"Puerto Rico","geoPoint":{"lat":18.42745,"lon":-66.49212}},{"facility":"American Telemedicine Center","city":"San Juan","zip":"00917-3104","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Salford","state":"Manchester","zip":"M6 8HD","country":"United Kingdom","geoPoint":{"lat":53.48771,"lon":-2.29042}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Dundee","state":"Scotland","zip":"DD1 9SY","country":"United Kingdom","geoPoint":{"lat":56.46913,"lon":-2.97489}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Sheffield","state":"South Yorkshire","zip":"S5 7AU","country":"United Kingdom","geoPoint":{"lat":53.38297,"lon":-1.4659}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ipswich","state":"Suffolk","zip":"IP4 5PD","country":"United Kingdom","geoPoint":{"lat":52.05917,"lon":1.15545}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Manchester","zip":"M41 5SL","country":"United Kingdom","geoPoint":{"lat":53.48095,"lon":-2.23743}}]},"referencesModule":{"references":[{"pmid":"28671753","type":"DERIVED","citation":"Heller SR, Pratley RE, Sinclair A, Festa A, Kiljanski J, Brusko CS, Duan R, Heine RJ. Glycaemic outcomes of an Individualized treatMent aPproach for oldER vulnerable patIents: A randomized, controlled stUdy in type 2 diabetes Mellitus (IMPERIUM). Diabetes Obes Metab. 2018 Jan;20(1):148-156. doi: 10.1111/dom.13051. Epub 2017 Aug 8."}]},"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 EU, whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"https://vivli.org/"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants completed the first 24 weeks of the study at which time the study was stopped and interim analysis was triggered to assess feasibility. Treatment continued per protocol until study termination and participants discontinued at the next office study visit. Data was assessed from Baseline to last participant visit, up to 72 weeks.","groups":[{"id":"FG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks."},{"id":"FG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according to treatment algorithm. Treatment may last up to 72 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"99"},{"groupId":"FG001","numSubjects":"93"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"98"},{"groupId":"FG001","numSubjects":"93"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"85"},{"groupId":"FG001","numSubjects":"78"}]}],"dropWithdraws":[{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"29"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"No Reason Provided","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Study Terminated by Sponsor","reasons":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks."},{"id":"BG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine dose is titrated according to treatment algorithm. Treatment may last up to 72 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"93"},{"groupId":"BG002","value":"192"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"70.7","spread":"5.3"},{"groupId":"BG001","value":"70.7","spread":"4.4"},{"groupId":"BG002","value":"70.7","spread":"4.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"77"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"115"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"67"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"122"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"16"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"93"},{"groupId":"BG001","value":"81"},{"groupId":"BG002","value":"174"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Austria","categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"32"}]}]},{"title":"Puerto Rico","categories":[{"measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"39"}]}]},{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"64"}]}]},{"title":"United Kingdom","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"21"}]}]},{"title":"Germany","categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"36"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia","description":"Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c \\> upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c \\> upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose \\<3.0 mmol/L. Success is defined as lacking of failure.","populationDescription":"All participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","dispersionType":"95% Confidence Interval","unitOfMeasure":"percentage of participants","timeFrame":"Baseline to last participant visit (up to 72 weeks)","groups":[{"id":"OG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks."},{"id":"OG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"64.5","lowerLimit":"54.4","upperLimit":"73.4"},{"groupId":"OG001","value":"54.9","lowerLimit":"44.6","upperLimit":"64.9"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy","populationDescription":"All participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline to last participant visit (up to 72 weeks)","groups":[{"id":"OG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks."},{"id":"OG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"13"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia","populationDescription":"All participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline to last participant visit (up to 72 weeks)","groups":[{"id":"OG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks."},{"id":"OG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"93"}]}],"classes":[{"title":"Total Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"50"}]}]},{"title":"Severe Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Clinically Significant Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Symptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"34"}]}]},{"title":"Asymptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"30"}]}]},{"title":"Probable Symptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"7"}]}]},{"title":"Unspecified Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"7"}]}]},{"title":"Relative Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"}]}]},{"title":"Nocturnal Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"10"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline of Urinary Albumin to Creatinine Ratio","description":"The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease.","populationDescription":"All participants who received at least one dose of study drug and had evaluable baseline and post-baseline urinary albumin to creatinine ratio.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milligram per millimole (mg/mmol)","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks."},{"id":"OG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"83"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.85","spread":"22.99"},{"groupId":"OG001","value":"1.85","spread":"16.46"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Mass Index (BMI)","populationDescription":"All participants who received at least one dose of study drug and had evaluable baseline and post-baseline BMI data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram per square meter (kg/m^2)","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks."},{"id":"OG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.47","spread":"1.56"},{"groupId":"OG001","value":"0.20","spread":"2.91"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)","description":"The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease.","populationDescription":"All participants who received at least one dose of study drug and had evaluable baseline and post-baseline eGFR data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milliliter per minute/1.73 square meter","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks."},{"id":"OG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.00","spread":"13.64"},{"groupId":"OG001","value":"-5.88","spread":"10.95"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score","populationDescription":"Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks."},{"id":"OG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score","populationDescription":"Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks."},{"id":"OG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change From Baseline in Mini-mental State Examination (MMSE) Score","populationDescription":"Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks."},{"id":"OG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","description":"All participants who received at least one dose of study drug.","eventGroups":[{"id":"EG000","title":"Strategy A (Glucose-Dependent)","description":"Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \\[GLP-1 RA\\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.","seriousNumAffected":15,"seriousNumAtRisk":98,"otherNumAffected":82,"otherNumAtRisk":98},{"id":"EG001","title":"Strategy B (Reference)","description":"Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.","seriousNumAffected":14,"seriousNumAtRisk":93,"otherNumAffected":74,"otherNumAtRisk":93}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":98},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":93}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":98},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":93}]},{"term":"Cardiac failure congestive","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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