{"protocolSection":{"identificationModule":{"nctId":"NCT01621178","orgStudyIdInfo":{"id":"13798"},"secondaryIdInfos":[{"id":"H9X-MC-GBDX","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2012-000829-44","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)","officialTitle":"A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-weekly Dulaglutide With Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes and Moderate or Severe Chronic Kidney Disease","acronym":"AWARD-7"},"statusModule":{"statusVerifiedDate":"2019-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-07"},"primaryCompletionDateStruct":{"date":"2016-06","type":"ACTUAL"},"completionDateStruct":{"date":"2016-12","type":"ACTUAL"},"studyFirstSubmitDate":"2012-06-14","studyFirstSubmitQcDate":"2012-06-14","studyFirstPostDateStruct":{"date":"2012-06-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-06-21","resultsFirstSubmitQcDate":"2017-06-21","resultsFirstPostDateStruct":{"date":"2017-07-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-09-06","lastUpdatePostDateStruct":{"date":"2019-09-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide compared to insulin glargine in the treatment of participants with type 2 diabetes and moderate or severe chronic kidney disease."},"conditionsModule":{"conditions":["Type 2 Diabetes","Chronic Kidney Disease"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE","maskingDescription":"Dulaglutide dose was blinded to participant, care provider, investigator and outcomes assessor."}},"enrollmentInfo":{"count":577,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Insulin glargine","type":"ACTIVE_COMPARATOR","description":"Insulin glargine was administered subcutaneously (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.","interventionNames":["Drug: Insulin glargine","Drug: Insulin lispro"]},{"label":"0.75 mg Dulaglutide","type":"EXPERIMENTAL","description":"0.75 milligram (mg) of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.","interventionNames":["Drug: Dulaglutide","Drug: Insulin lispro"]},{"label":"1.5 mg Dulaglutide","type":"EXPERIMENTAL","description":"1.5 mg of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.","interventionNames":["Drug: Dulaglutide","Drug: Insulin lispro"]}],"interventions":[{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["0.75 mg Dulaglutide","1.5 mg Dulaglutide"],"otherNames":["LY2189265"]},{"type":"DRUG","name":"Insulin glargine","description":"Administered SC","armGroupLabels":["Insulin glargine"]},{"type":"DRUG","name":"Insulin lispro","description":"Administered SC","armGroupLabels":["0.75 mg Dulaglutide","1.5 mg Dulaglutide","Insulin glargine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment\\*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.","timeFrame":"Baseline, 26 Weeks"}],"secondaryOutcomes":[{"measure":"Percentage of Participants Whose HbA1c Was <7.0%","description":"Percentage of participants whose HbA1c was \\<7.0% based on last observation carried forward (LOCF).","timeFrame":"26 Weeks"},{"measure":"Percentage of Participants Whose HbA1c Was <8.0%","description":"Percentage of Participants whose HbA1c was \\<8.0% based on last observation carried forward (LOCF).","timeFrame":"26 Weeks"},{"measure":"Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)","description":"The daily mean of 8-point SMPG profile at Week 26 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment\\*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x \\[morning, midday, and evening meals in one day\\] + bedtime + 5 hours after bedtime).","timeFrame":"Baseline, 26 Weeks"},{"measure":"Change From Baseline in Fasting Glucose (FG)","description":"LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment\\*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured","timeFrame":"Baseline, 26 Weeks"},{"measure":"Change From Baseline in Mean Daily Insulin Lispro Dose","description":"The mean daily insulin was based on a 4-week interval prior to week 26 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment\\*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.","timeFrame":"Baseline, 26 Weeks"},{"measure":"Percentage of Participants With Estimated Average Glucose <154 mg/dL","description":"Percentage of Participants With Estimated Average Glucose \\<154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).","timeFrame":"26 Weeks"},{"measure":"Change From Baseline in Serum Creatinine (sCr)","description":"Change from baseline in serum creatinine (sCr) levels after treatment.","timeFrame":"Baseline, 26 Weeks"},{"measure":"Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)","description":"The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.","timeFrame":"Baseline, 26 Weeks"},{"measure":"Change From Baseline in Estimated Creatinine Clearance (eCrCl)","description":"Estimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault \\[Cockcroft and Gault 1976\\] equation using baseline estimated lean body weight.","timeFrame":"Baseline, 26 Weeks"},{"measure":"Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)","description":"The change from baseline in Urinary Albumin to Creatinine Ratio (UACR).","timeFrame":"Baseline, 26 Weeks"},{"measure":"Change From Baseline in Body Weight","description":"LS means were calculated from a REML based MMRM model: Change from Baseline = treatment, week, treatment\\*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.\n\n•","timeFrame":"Baseline, 26 Weeks"},{"measure":"Percentage of Participants With Self-Reported Hypoglycemic Events (HE)","description":"Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.","timeFrame":"Baseline through 26 Weeks"},{"measure":"Rate of Hypoglycemic Events","description":"Hypoglycemic events (HE) were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.","timeFrame":"Baseline through 26 Weeks"},{"measure":"Change From Baseline in HbA1c","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means in HbA1c were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, MA region, Baseline CKD Severity, week, treatment\\*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.","timeFrame":"Baseline, 52 Weeks"},{"measure":"Percentage of Participants Whose HbA1c is <7.0%","description":"Percentage of participants whose HbA1c was \\<7.0% based on last observation carried forward (LOCF).","timeFrame":"52 Weeks"},{"measure":"Percentage of Participants Whose HbA1c is <8.0%","description":"Percentage of participants whose HbA1c was \\<8.0% based on last observation carried forward (LOCF).","timeFrame":"52 Weeks"},{"measure":"Change From Baseline in 8-Point SMPG","description":"The daily mean of 8-point SMPG profile at Week 52 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment\\*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x \\[morning, midday, and evening meals in one day\\] + bedtime + 5 hours after bedtime).","timeFrame":"Baseline, 52 Weeks"},{"measure":"Change From Baseline in FG","description":"LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment\\*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured","timeFrame":"Baseline, 52 Weeks"},{"measure":"Change in Mean Daily Insulin Lispro Dose","description":"The mean daily insulin was based on a 4-week interval prior to week 52 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment\\*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.","timeFrame":"Baseline, 52 Weeks"},{"measure":"Percentage of Participants With Estimated Average Glucose <154 mg/dL","description":"Percentage of Participants With Estimated Average Glucose \\<154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).","timeFrame":"52 Weeks"},{"measure":"Change From Baseline in sCr","description":"Change from baseline in sCr levels after treatment.","timeFrame":"Baseline, 52 Weeks"},{"measure":"Change From Baseline in eGFR","description":"The change in eGFR by using CKD-EPI equation.","timeFrame":"Baseline, 52 Weeks"},{"measure":"Change From Baseline in eCrCl","description":"eCrCl was calculated by Cockcroft-Gault \\[Cockcroft and Gault 1976\\] equation using baseline estimated lean body weight.","timeFrame":"Baseline, 52 Weeks"},{"measure":"Change From Baseline in UACR","description":"The change from baseline in UACR","timeFrame":"Baseline, 52 Weeks"},{"measure":"Change From Baseline in Body Weight","description":"LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment\\*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.","timeFrame":"Baseline, 52 Weeks"},{"measure":"Percentage of Participants With Self-Reported Hypoglycemic Events (HE)","description":"Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.","timeFrame":"Baseline through 52 Weeks"},{"measure":"Rate of Hypoglycemic Events (HE)","description":"HE were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.","timeFrame":"Baseline through 52 Weeks"},{"measure":"Participants With Events of Allergic/Hypersensitivity Reactions","description":"Participants with Events of Allergic/Hypersensitivity Reactions: Angioedema Standardized MedDRA Query (SMQ), Anaphylactic Reaction SMQ, or Severe Cutaneous Adverse Reactions SMQ","timeFrame":"Baseline through 52 Weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Men and non-pregnant women aged ≥18 years\n* Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%\n* Type 2 diabetes on insulin or insulin + oral antihyperglycemic medication\n* Participants with presumed diabetic kidney disease with or without hypertensive nephrosclerosis diagnosed with moderate or severe CKD with estimated glomerular filtration rate (eGFR) of ≥15 to \\<60 milliliters per minute (mL/min)/1.73 meter squared (m\\^2)\n* Able and willing to perform multiple daily injections\n* Body mass index (BMI) between 23 and 45 kilogram/square meter (kg/m\\^2)\n\nExclusion Criteria:\n\n* Stage 5 CKD as defined by eGFR \\<15 mL/min/1.73 m\\^2 OR having required dialysis\n* Rapidly progressing renal dysfunction likely to require renal replacement\n* History of a transplanted organ\n* Type 1 diabetes mellitus\n* At screening a systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥90 mmHg with or without antihypertensive medication\n* An episode of ketoacidosis or hyperosmolar state/coma in the past 6 months or a history of severe hypoglycemia in the past 3 months prior to the Screening Visit\n* Cardiovascular conditions within 12 weeks prior to randomization: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke)\n* Acute or chronic hepatitis\n* Signs and symptoms of chronic or acute pancreatitis, or were in the past diagnosed with pancreatitis\n* Serum calcitonin ≥35 picograms per milliliter (pg/mL) at Screening Visit\n* Self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma\n* Known history of untreated proliferative retinopathy","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":"Extended Arm Physician, Inc.","city":"Montgomery","state":"Alabama","zip":"36106","country":"United States","geoPoint":{"lat":32.36681,"lon":-86.29997}},{"facility":"North American Research Institute","city":"Azusa","state":"California","zip":"91702","country":"United States","geoPoint":{"lat":34.13362,"lon":-117.90756}},{"facility":"Renal Consultants Medical Group","city":"Granada 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Passo Fundo","zip":"99010-080","country":"Brazil","geoPoint":{"lat":-28.26278,"lon":-52.40667}},{"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":"Porto Alegre","zip":"90610000","country":"Brazil","geoPoint":{"lat":-30.03283,"lon":-51.23019}},{"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":"Santa Catarina","zip":"89227680","country":"Brazil","geoPoint":{"lat":-22.42637,"lon":-43.23751}},{"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":"São Paulo","zip":"04025-011","country":"Brazil","geoPoint":{"lat":-23.5475,"lon":-46.63611}},{"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":"Baja","zip":"6500","country":"Hungary","geoPoint":{"lat":46.18299,"lon":18.95307}},{"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":"Budapest","zip":"1036","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"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":"Esztergom","zip":"2500","country":"Hungary","geoPoint":{"lat":47.7928,"lon":18.74148}},{"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":"Kaposvár","zip":"7400","country":"Hungary","geoPoint":{"lat":46.36667,"lon":17.8}},{"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":"Kecskemét","zip":"6000","country":"Hungary","geoPoint":{"lat":46.90618,"lon":19.69128}},{"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":"Pécs","zip":"7623","country":"Hungary","geoPoint":{"lat":46.07617,"lon":18.22814}},{"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":"Sátoraljaújhely","zip":"H-3980","country":"Hungary","geoPoint":{"lat":48.39492,"lon":21.65871}},{"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":"Siófok","zip":"8600","country":"Hungary","geoPoint":{"lat":46.90413,"lon":18.058}},{"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":"Chihuahua City","zip":"31000","country":"Mexico","geoPoint":{"lat":28.63528,"lon":-106.08889}},{"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":"Culiacán","zip":"80030","country":"Mexico","geoPoint":{"lat":24.80209,"lon":-107.39421}},{"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":"Guadalajara","zip":"44650","country":"Mexico","geoPoint":{"lat":20.67738,"lon":-103.34749}},{"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":"Mexico City","zip":"11850","country":"Mexico","geoPoint":{"lat":19.42847,"lon":-99.12766}},{"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":"Monterrey","zip":"64000","country":"Mexico","geoPoint":{"lat":25.68435,"lon":-100.31721}},{"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":"Gdansk","zip":"80-952","country":"Poland","geoPoint":{"lat":54.35227,"lon":18.64912}},{"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":"Lodz","zip":"90302","country":"Poland","geoPoint":{"lat":51.77058,"lon":19.47395}},{"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":"Szczecin","zip":"70-111","country":"Poland","geoPoint":{"lat":53.42894,"lon":14.55302}},{"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":"Zgierz","zip":"95-100","country":"Poland","geoPoint":{"lat":51.85561,"lon":19.40623}},{"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":"Bacau","zip":"600114","country":"Romania","geoPoint":{"lat":46.56718,"lon":26.91384}},{"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":"Bucharest","zip":"020045","country":"Romania","geoPoint":{"lat":44.43225,"lon":26.10626}},{"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":"Deva","zip":"330084","country":"Romania","geoPoint":{"lat":45.88333,"lon":22.9}},{"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":"Oradea","zip":"410167","country":"Romania","geoPoint":{"lat":47.0458,"lon":21.91833}},{"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":"Târgu Mureş","zip":"540142","country":"Romania","geoPoint":{"lat":46.54245,"lon":24.55747}},{"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":"Timișoara","zip":"300125","country":"Romania","geoPoint":{"lat":45.75372,"lon":21.22571}},{"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":"Cape Town","zip":"7925","country":"South Africa","geoPoint":{"lat":-33.92584,"lon":18.42322}},{"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":"Durban","zip":"4091","country":"South Africa","geoPoint":{"lat":-29.8579,"lon":31.0292}},{"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":"Johannesburg","zip":"2198","country":"South Africa","geoPoint":{"lat":-26.20227,"lon":28.04363}},{"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":"Somerset West","zip":"7130","country":"South Africa","geoPoint":{"lat":-34.08401,"lon":18.82113}},{"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":"Worcester","zip":"6850","country":"South Africa","geoPoint":{"lat":-33.64651,"lon":19.44852}},{"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":"Barcelona","zip":"08036","country":"Spain","geoPoint":{"lat":41.38879,"lon":2.15899}},{"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":"Valencia","zip":"46026","country":"Spain","geoPoint":{"lat":39.47391,"lon":-0.37966}},{"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":"Dnipropetrovsk","zip":"49005","country":"Ukraine","geoPoint":{"lat":48.46664,"lon":35.04066}},{"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":"Kyiv","zip":"2091","country":"Ukraine","geoPoint":{"lat":50.45466,"lon":30.5238}},{"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":"Luhansk","zip":"91045","country":"Ukraine","geoPoint":{"lat":48.56814,"lon":39.30553}},{"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":"Poltava","zip":"36011","country":"Ukraine","geoPoint":{"lat":49.58925,"lon":34.55367}},{"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":"Ternopil","zip":"46002","country":"Ukraine","geoPoint":{"lat":49.55404,"lon":25.59067}}]},"referencesModule":{"references":[{"pmid":"39963952","type":"DERIVED","citation":"Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2."},{"pmid":"29910024","type":"DERIVED","citation":"Tuttle KR, Lakshmanan MC, Rayner B, Busch RS, Zimmermann AG, Woodward DB, Botros FT. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018 Aug;6(8):605-617. doi: 10.1016/S2213-8587(18)30104-9. Epub 2018 Jun 14."}]},"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":"This was a parallel-arm, non-inferiority study. Study treatment continued for up to 52 weeks and participants were randomized in a 1:1:1 ratio to one of the 3 treatment arms: 1.5 milligrams (mg) dulaglutide once-weekly , 0.75 mg dulaglutide once-weekly, or insulin glargine once-daily.","groups":[{"id":"FG000","title":"Insulin Glargine","description":"Insulin glargine was administered subcutaneously (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"FG001","title":"0.75 mg Dulaglutide","description":"0.75 milligram (mg) of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"FG002","title":"1.5 mg Dulaglutide","description":"1.5 mg of dulaglutide was administered once weekly as a SC injection. 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Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment\\*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered subcutaneous (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"175"},{"groupId":"OG001","value":"149"},{"groupId":"OG002","value":"138"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.13","spread":"0.12"},{"groupId":"OG001","value":"-1.12","spread":"0.12"},{"groupId":"OG002","value":"-1.19","spread":"0.13"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Week 26","nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"Non-Inferiority to Glargine with a 0.4% margin","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.15"},{"groupIds":["OG000","OG001"],"groupDescription":"Week 26","nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"Non-Inferiority to Glargine with a 0.4% margin","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.22"}]},{"type":"SECONDARY","title":"Percentage of Participants Whose HbA1c Was <7.0%","description":"Percentage of participants whose HbA1c was \\<7.0% based on last observation carried forward (LOCF).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"182"},{"groupId":"OG001","value":"164"},{"groupId":"OG002","value":"152"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34.6"},{"groupId":"OG001","value":"31.7"},{"groupId":"OG002","value":"37.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Whose HbA1c Was <8.0%","description":"Percentage of Participants whose HbA1c was \\<8.0% based on last observation carried forward (LOCF).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"182"},{"groupId":"OG001","value":"164"},{"groupId":"OG002","value":"152"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"75.3"},{"groupId":"OG001","value":"72.6"},{"groupId":"OG002","value":"78.3"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)","description":"The daily mean of 8-point SMPG profile at Week 26 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment\\*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x \\[morning, midday, and evening meals in one day\\] + bedtime + 5 hours after bedtime).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and SMPG data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligrams/deciliter (mg/dL)","timeFrame":"Baseline, 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"107"},{"groupId":"OG002","value":"102"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-37.6","spread":"3.41"},{"groupId":"OG001","value":"-31.7","spread":"3.53"},{"groupId":"OG002","value":"-33.7","spread":"3.77"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Glucose (FG)","description":"LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment\\*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and FG data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milligram/deciliter (mg/dL)","timeFrame":"Baseline, 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"162"},{"groupId":"OG001","value":"145"},{"groupId":"OG002","value":"132"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-19.1","spread":"6.00"},{"groupId":"OG001","value":"17.7","spread":"6.14"},{"groupId":"OG002","value":"23.1","spread":"6.50"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Mean Daily Insulin Lispro Dose","description":"The mean daily insulin was based on a 4-week interval prior to week 26 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment\\*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and insulin lispro dose data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units/day (U/day)","timeFrame":"Baseline, 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"177"},{"groupId":"OG001","value":"154"},{"groupId":"OG002","value":"141"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.64","spread":"2.76"},{"groupId":"OG001","value":"26.16","spread":"2.80"},{"groupId":"OG002","value":"18.12","spread":"3.00"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Estimated Average Glucose <154 mg/dL","description":"Percentage of Participants With Estimated Average Glucose \\<154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable HbA1c and average self-monitored plasma glucose post-baseline data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"118"},{"groupId":"OG002","value":"110"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"64.9"},{"groupId":"OG001","value":"52.5"},{"groupId":"OG002","value":"56.4"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Serum Creatinine (sCr)","description":"Change from baseline in serum creatinine (sCr) levels after treatment.","populationDescription":"All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline sCr data.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mg/dL","timeFrame":"Baseline, 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"169"},{"groupId":"OG002","value":"163"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.10","lowerLimit":"-0.04","upperLimit":"0.28"},{"groupId":"OG001","value":"0.02","lowerLimit":"-0.15","upperLimit":"0.15"},{"groupId":"OG002","value":"0.04","lowerLimit":"-0.14","upperLimit":"0.20"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)","description":"The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline eGFR data.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"milliliter/minute/1.73m2 (mL/min/1.73m2)","timeFrame":"Baseline, 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"169"},{"groupId":"OG002","value":"163"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.5","lowerLimit":"-6.0","upperLimit":"1.0"},{"groupId":"OG001","value":"-1.0","lowerLimit":"-4.5","upperLimit":"3.0"},{"groupId":"OG002","value":"-1.0","lowerLimit":"-5.5","upperLimit":"3.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Estimated Creatinine Clearance (eCrCl)","description":"Estimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault \\[Cockcroft and Gault 1976\\] equation using baseline estimated lean body weight.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline eCrCl data.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"milliliter/minute (ml/min)","timeFrame":"Baseline, 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"169"},{"groupId":"OG002","value":"163"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","lowerLimit":"-4.0","upperLimit":"0.5"},{"groupId":"OG001","value":"-1.0","lowerLimit":"-3.5","upperLimit":"2.0"},{"groupId":"OG002","value":"-0.5","lowerLimit":"-4.0","upperLimit":"2.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)","description":"The change from baseline in Urinary Albumin to Creatinine Ratio (UACR).","populationDescription":"All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline UACR data.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"gram/kilogram (g/kg)","timeFrame":"Baseline, 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"181"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"175"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","lowerLimit":"-71.7","upperLimit":"62.0"},{"groupId":"OG001","value":"-11.1","lowerLimit":"-147.8","upperLimit":"33.2"},{"groupId":"OG002","value":"-10.2","lowerLimit":"-180.5","upperLimit":"53.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"LS means were calculated from a REML based MMRM model: Change from Baseline = treatment, week, treatment\\*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.\n\n•","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram (kg)","timeFrame":"Baseline, 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"175"},{"groupId":"OG001","value":"151"},{"groupId":"OG002","value":"140"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.11","spread":"0.346"},{"groupId":"OG001","value":"-2.02","spread":"0.357"},{"groupId":"OG002","value":"-2.81","spread":"0.374"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Self-Reported Hypoglycemic Events (HE)","description":"Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable post-baseline HE data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"189"},{"groupId":"OG002","value":"190"}]}],"classes":[{"title":"Total Hypo","categories":[{"measurements":[{"groupId":"OG000","value":"71.6"},{"groupId":"OG001","value":"50.8"},{"groupId":"OG002","value":"43.2"}]}]},{"title":"Documented Symptomatic Hypo","categories":[{"measurements":[{"groupId":"OG000","value":"60.3"},{"groupId":"OG001","value":"40.7"},{"groupId":"OG002","value":"31.6"}]}]},{"title":"Severe Hypo","categories":[{"measurements":[{"groupId":"OG000","value":"4.1"},{"groupId":"OG001","value":"1.1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Nocturnal Hypo","categories":[{"measurements":[{"groupId":"OG000","value":"38.1"},{"groupId":"OG001","value":"15.9"},{"groupId":"OG002","value":"13.2"}]}]}]},{"type":"SECONDARY","title":"Rate of Hypoglycemic Events","description":"Hypoglycemic events (HE) were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.","populationDescription":"All randomized participants who had received at least one dose of study drug and had evaluable post-baseline HE rate data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Events/Participant/Year","timeFrame":"Baseline through 26 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine administered SC to be given at bedtime per sliding scale. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"189"},{"groupId":"OG002","value":"190"}]}],"classes":[{"title":"Total HE Rate","categories":[{"measurements":[{"groupId":"OG000","value":"17.07","spread":"27.70"},{"groupId":"OG001","value":"7.76","spread":"20.39"},{"groupId":"OG002","value":"5.45","spread":"12.54"}]}]},{"title":"Documented Symptomatic HE Rate","categories":[{"measurements":[{"groupId":"OG000","value":"11.34","spread":"22.04"},{"groupId":"OG001","value":"4.86","spread":"13.37"},{"groupId":"OG002","value":"4.19","spread":"11.58"}]}]},{"title":"Severe HE Rate","categories":[{"measurements":[{"groupId":"OG000","value":"0.10","spread":"0.56"},{"groupId":"OG001","value":"0.03","spread":"0.31"},{"groupId":"OG002","value":"0.00","spread":"0.00"}]}]},{"title":"Nocturnal HE Rate","categories":[{"measurements":[{"groupId":"OG000","value":"3.06","spread":"7.26"},{"groupId":"OG001","value":"0.73","spread":"2.25"},{"groupId":"OG002","value":"0.63","spread":"2.26"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means in HbA1c were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, MA region, Baseline CKD Severity, week, treatment\\*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"132"},{"groupId":"OG002","value":"130"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.00","spread":"0.12"},{"groupId":"OG001","value":"-1.10","spread":"0.12"},{"groupId":"OG002","value":"-1.10","spread":"0.13"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Whose HbA1c is <7.0%","description":"Percentage of participants whose HbA1c was \\<7.0% based on last observation carried forward (LOCF).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"182"},{"groupId":"OG001","value":"164"},{"groupId":"OG002","value":"152"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29.1"},{"groupId":"OG001","value":"33.5"},{"groupId":"OG002","value":"32.9"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Whose HbA1c is <8.0%","description":"Percentage of participants whose HbA1c was \\<8.0% based on last observation carried forward (LOCF).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"182"},{"groupId":"OG001","value":"164"},{"groupId":"OG002","value":"152"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"70.3"},{"groupId":"OG001","value":"69.5"},{"groupId":"OG002","value":"69.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 8-Point SMPG","description":"The daily mean of 8-point SMPG profile at Week 52 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment\\*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x \\[morning, midday, and evening meals in one day\\] + bedtime + 5 hours after bedtime).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and SMPG data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"102"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-40.5","spread":"3.59"},{"groupId":"OG001","value":"-30.0","spread":"3.75"},{"groupId":"OG002","value":"-27.2","spread":"3.93"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in FG","description":"LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment\\*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and FG data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"132"},{"groupId":"OG002","value":"131"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.4","spread":"6.38"},{"groupId":"OG001","value":"20.8","spread":"6.58"},{"groupId":"OG002","value":"28.3","spread":"6.87"}]}]}]},{"type":"SECONDARY","title":"Change in Mean Daily Insulin Lispro Dose","description":"The mean daily insulin was based on a 4-week interval prior to week 52 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment\\*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and insulin lispro dose data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"U/day","timeFrame":"Baseline, 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"140"},{"groupId":"OG002","value":"132"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.84","spread":"2.87"},{"groupId":"OG001","value":"27.46","spread":"2.93"},{"groupId":"OG002","value":"20.05","spread":"3.13"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Estimated Average Glucose <154 mg/dL","description":"Percentage of Participants With Estimated Average Glucose \\<154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable HbA1c and average self-monitored plasma glucose post-baseline data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"116"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"73.7"},{"groupId":"OG001","value":"57.4"},{"groupId":"OG002","value":"50.9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in sCr","description":"Change from baseline in sCr levels after treatment.","populationDescription":"All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline sCr data.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mg/dL","timeFrame":"Baseline, 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"157"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.12","lowerLimit":"-0.05","upperLimit":"0.38"},{"groupId":"OG001","value":"0.04","lowerLimit":"-0.11","upperLimit":"0.27"},{"groupId":"OG002","value":"0.07","lowerLimit":"-0.11","upperLimit":"0.21"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in eGFR","description":"The change in eGFR by using CKD-EPI equation.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline eGFR data.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mL/min/1.73m2","timeFrame":"Baseline, 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"157"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.3","lowerLimit":"-7.5","upperLimit":"1.0"},{"groupId":"OG001","value":"-1.5","lowerLimit":"-5.5","upperLimit":"2.5"},{"groupId":"OG002","value":"-2.0","lowerLimit":"-6.0","upperLimit":"2.5"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in eCrCl","description":"eCrCl was calculated by Cockcroft-Gault \\[Cockcroft and Gault 1976\\] equation using baseline estimated lean body weight.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline eCrCl data.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mL/min","timeFrame":"Baseline, 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"157"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.5","lowerLimit":"-5.8","upperLimit":"0.5"},{"groupId":"OG001","value":"-1.3","lowerLimit":"-4.0","upperLimit":"1.5"},{"groupId":"OG002","value":"-1.5","lowerLimit":"-5.0","upperLimit":"1.5"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in UACR","description":"The change from baseline in UACR","populationDescription":"All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline UACR data.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"g/kg","timeFrame":"Baseline, 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"162"},{"groupId":"OG002","value":"159"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.5","lowerLimit":"-56.2","upperLimit":"138.1"},{"groupId":"OG001","value":"-3.0","lowerLimit":"-88.5","upperLimit":"87.6"},{"groupId":"OG002","value":"-11.5","lowerLimit":"-158.0","upperLimit":"42.9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment\\*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Baseline, 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"132"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.57","spread":"0.429"},{"groupId":"OG001","value":"-1.71","spread":"0.448"},{"groupId":"OG002","value":"-2.66","spread":"0.467"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Self-Reported Hypoglycemic Events (HE)","description":"Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable post-baseline HE data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"189"},{"groupId":"OG002","value":"190"}]}],"classes":[{"title":"Total Hypo","categories":[{"measurements":[{"groupId":"OG000","value":"74.7"},{"groupId":"OG001","value":"59.8"},{"groupId":"OG002","value":"50.0"}]}]},{"title":"Documented Symptomatic Hypo","categories":[{"measurements":[{"groupId":"OG000","value":"63.4"},{"groupId":"OG001","value":"48.1"},{"groupId":"OG002","value":"40.5"}]}]},{"title":"Severe Hypo","categories":[{"measurements":[{"groupId":"OG000","value":"6.7"},{"groupId":"OG001","value":"2.6"},{"groupId":"OG002","value":"0"}]}]},{"title":"Nocturnal Hypo","categories":[{"measurements":[{"groupId":"OG000","value":"47.9"},{"groupId":"OG001","value":"23.8"},{"groupId":"OG002","value":"20.5"}]}]}]},{"type":"SECONDARY","title":"Rate of Hypoglycemic Events (HE)","description":"HE were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.","populationDescription":"All randomized participants who had received at least one dose of study drug and had evaluable post-baseline HE rate data. Only measurements prior to rescue or study drug discontinuation were used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Events/Participant/Year","timeFrame":"Baseline through 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"189"},{"groupId":"OG002","value":"190"}]}],"classes":[{"title":"Total HE Rate","categories":[{"measurements":[{"groupId":"OG000","value":"14.36","spread":"22.20"},{"groupId":"OG001","value":"7.59","spread":"17.81"},{"groupId":"OG002","value":"5.82","spread":"13.70"}]}]},{"title":"Documented Symptomatic HE Rate","categories":[{"measurements":[{"groupId":"OG000","value":"9.62","spread":"17.72"},{"groupId":"OG001","value":"4.34","spread":"9.30"},{"groupId":"OG002","value":"4.44","spread":"12.23"}]}]},{"title":"Severe HE Rate","categories":[{"measurements":[{"groupId":"OG000","value":"0.09","spread":"0.37"},{"groupId":"OG001","value":"0.03","spread":"0.21"},{"groupId":"OG002","value":"0.00","spread":"0.00"}]}]},{"title":"Nocturnal HE Rate","categories":[{"measurements":[{"groupId":"OG000","value":"2.48","spread":"5.10"},{"groupId":"OG001","value":"0.76","spread":"2.09"},{"groupId":"OG002","value":"0.70","spread":"2.29"}]}]}]},{"type":"SECONDARY","title":"Participants With Events of Allergic/Hypersensitivity Reactions","description":"Participants with Events of Allergic/Hypersensitivity Reactions: Angioedema Standardized MedDRA Query (SMQ), Anaphylactic Reaction SMQ, or Severe Cutaneous Adverse Reactions SMQ","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants with events","timeFrame":"Baseline through 52 Weeks","groups":[{"id":"OG000","title":"Insulin Glargine","description":"Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG001","title":"Dulaglutide 0.75 mg","description":"Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"190"},{"groupId":"OG002","value":"192"}]}],"classes":[{"title":"Angioedema SMQ","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"}]}]},{"title":"Angioedema","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Eyelid edema","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Face edema","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Urticaria","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Anaphylactic Reaction SMQ","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Circulatory collapse","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Severe Cutaneous Adverse Reactions SMQ","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Up To Week 52","description":"Safety population included those participants who received at least one dose of study drug.","eventGroups":[{"id":"EG000","title":"Insulin Glargine","description":"Insulin glargine administered SC to be given at bedtime per sliding scale. 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