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)
Condition: Type 2 Diabetes; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Insulin glargine; Insulin lispro
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Dulaglutide dose was blinded to participant, care provider, investigator and outcomes assessor.
Enrollment: 577.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and non-pregnant women aged ≥18 years

          -  Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%

          -  Type 2 diabetes on insulin or insulin + oral antihyperglycemic medication

          -  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)

          -  Able and willing to perform multiple daily injections

          -  Body mass index (BMI) between 23 and 45 kilogram/square meter (kg/m^2)

        Exclusion Criteria:

          -  Stage 5 CKD as defined by eGFR <15 mL/min/1.73 m^2 OR having required dialysis

          -  Rapidly progressing renal dysfunction likely to require renal replacement

          -  History of a transplanted organ

          -  Type 1 diabetes mellitus

          -  At screening a systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of
             ≥90 mmHg with or without antihypertensive medication

          -  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

          -  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)

          -  Acute or chronic hepatitis

          -  Signs and symptoms of chronic or acute pancreatitis, or were in the past diagnosed
             with pancreatitis

          -  Serum calcitonin ≥35 picograms per milliliter (pg/mL) at Screening Visit

          -  Self or family history of medullary C-cell hyperplasia, focal hyperplasia, or
             carcinoma

          -  Known history of untreated proliferative retinopathy