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)

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dulaglutide; Immunoglobulin Fc Fragments; Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc

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