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
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/27/2018
Start Date:July 2012
End Date:December 2016

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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

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.


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
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Houston, Texas 77004
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3890 Tampa Rd # 302
Palm Harbor, Florida 34684
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
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Albany, New York 12206
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Chattanooga, Tennessee 37404
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Concord, North Carolina 28025
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Dallas, Texas 75231
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Greenville, North Carolina 27834
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Knoxville, Tennessee 37923
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Morehead City, North Carolina 28557
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Orangeburg, South Carolina 29118
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Pittsburgh, Pennsylvania 15224
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