A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease



Status:Not yet recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:July 1, 2019
End Date:August 19, 2024
Contact:Novo Nordisk
Email:clinicaltrials@novonordisk.com
Phone:(+1) 866-867-7178

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Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease

The researchers are doing this study to see if semaglutide can slow down the growth and
worsening of chronic kidney disease in people with type 2 diabetes. Participants will get
semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants'
study medicine - which treatment participants get is decided by chance. Semaglutide is a
medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes.
Participants will get the study medicine in a pen. Participants will use the pen to inject
the medicine in a skin fold once a week. The study will close when there is enough
information collected to show clear result of the study. The total time participants will be
in this study is about 3 to 5 years, but it could be longer.


Inclusion Criteria:

- Male or female, age above or equal to 18 years at the time of signing informed
consent. Japan: Male or female, age above or equal to 20 years at the time of signing
informed consent

- Diagnosed with type 2 diabetes mellitus

- HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)

- Renal impairment defined either by:

1. serum creatinine-based eGFR greater than or equal to 50 and less than or equal to
75 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or

2. serum creatinine-based eGFR greater than or equal to 25 and less than 50
mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g

- Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone
system (RAAS) blocking agent including an angiotensin converting enzyme (ACE)
inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is
contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks
prior to the date of the laboratory assessments used for determination of the
inclusion criteria for renal impairment and kept stable until screening

Exclusion Criteria:

- Congenital or hereditary kidney diseases including polycystic kidney disease,
autoimmune kidney diseases including glomerulonephritis or congenital urinary tract
malformations

- Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to
screening

- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or
transient ischaemic attack within 60 days prior to the day of screening

- Presently classified as being in New York Heart Association (NYHA) Class IV heart
failure

- Planned coronary, carotid or peripheral artery revascularisation

- Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal
dialysis

- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by
a fundus examination performed within the past 90 days prior to screening or in the
period between screening and randomisation. Pharmacological pupil-dilation is a
requirement unless using a digital fundus photography camera specified for non-dilated
examination
We found this trial at
13
sites
Atlanta, Georgia 30318
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Atlanta, GA
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Beltsville, Maryland 20705
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Beltsville, MD
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Caba,
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Flint, Michigan 48504
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Flint, MI
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Franklin, Ohio 45005
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Franklin, OH
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Fresno, California 93702
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Fresno, CA
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Lancaster, California 93534
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Lancaster, CA
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Morganton, North Carolina 28655
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Morganton, NC
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Norfolk, Virginia 23510
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Norfolk, VA
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Port Hueneme, California 93041
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Port Hueneme, CA
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Rialto, California 92376
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Rialto, CA
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Sugar Land, Texas 77479
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Sugar Land, TX
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West Seneca, New York 14224
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from
West Seneca, NY
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