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)
Completed · Phase 3
Conditions studied: Type 2 Diabetes, Chronic Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT01621178
- Run by
- Eli Lilly and Company
- People needed
- 577
- Starts
- 2012-07-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2019-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- North American Research Institute — Azusa, California, United States
- Renal Consultants Medical Group — Granada Hills, California, United States
- Marin Endocrine Associates — Greenbrae, California, United States
- Academic Medical Research Institute — Los Angeles, California, United States
- Sutter Gould Medical Foundation — Modesto, California, United States
- Infosphere — West Hills, California, United States
- Chase Medical Research, LLC — Waterbury, Connecticut, United States
- The Center for Diabetes & Endocrine Care — Hollywood, Florida, United States
- East Coast Clinical Research — Jacksonville, Florida, United States
- San Marcus Research Clinic, Inc. — Miami, Florida, United States
- Pharmax Research Clinic — Miami, Florida, United States
- Avanced Medical and Pain Mangement Research Clinic (AMPM) — Miami, Florida, United States
- Baptist Diabetes Association — Miami, Florida, United States
- Ocean Blue Medical Research Center, Inc. — Miami Springs, Florida, United States
- Suncoast Clinical Research — New Port Richey, Florida, United States
- Discovery Medical Research Group — Ocala, Florida, United States
- Suncoast Clinical Research — Palm Harbor, Florida, United States
- University of Hawaii Clinical Research — Honolulu, Hawaii, United States
- Boise Kidney & Hypertension Institute — Caldwell, Idaho, United States
- Pacific Renal Research Institute — Meridian, Idaho, United States
- Cotton O'Neil Clinic — Topeka, Kansas, United States
- Univ of Kansas Schl of Medicine , Wichita — Wichita, Kansas, United States
- Penobscot Bay Medical Center — Rockport, Maine, United States
- Nebraska Nephrology Research Institute, LLC — Lincoln, Nebraska, United States
- Extended Arm Physician, Inc. — Montgomery, Alabama, United States
Full record on ClinicalTrials.gov
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