Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:September 20, 2016
End Date:May 15, 2018

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This trial is conducted globally. The aim of this trial is to investigate efficacy and safety
of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal
impairment.


Inclusion Criteria: - Informed consent obtained before any trial-related activities.
Trial-related activities are any procedures that are carried out as part of the trial,
including activities to determine suitability for the trial - Male or female, age above or
equal to 18 years at the time of signing informed consent - Diagnosed with type 2 diabetes
mellitus for at least 90 days prior to day of screening - HbA1c (glycosylated haemoglobin)
of 7.0-9.5% (53-80 mmol/mol) (both inclusive) - Moderate renal impairment defined as
estimated glomerular filtration rate of 30-59 mL/min/1.73 m^2 as per Chronic Kidney Disease
Epidemiology Collaboration formula - Stable daily dose(s) within 90 days prior to the day
of screening of any of the following treatment regimens:- 1-2 of the following oral
anti-diabetic drugs: - Metformin equal or above 1500 mg or maximum tolerated dose
documented in the subject medical record), - Sulfonylurea (equal or above half of the
maximum approved dose according to local label or maximum tolerated dose as documented in
subject medical record) - Basal insulin alone (20% change in total daily dose of insulin
glargine, insulin detemir, insulin degludec or NPH insulin) or - Metformin (equal or above
1500 mg or maximum tolerated dose documented in the subject medical record) in combination
with basal insulin (20% change in total daily dose of insulin glargine, insulin detemir,
insulin degludec or NPH insulin) Exclusion Criteria: - Female who is pregnant,
breast-feeding or intends to become pregnant or is of child-bearing potential and not using
an adequate contraceptive method (adequate contraceptive measure as required by local
regulation or practice).For certain specific countries: Additional specific requirements
apply - Any disorder, which in the investigator's opinion might jeopardise subject's safety
or compliance with the protocol - Family or personal history of Multiple Endocrine
Neoplasia Type 2 or Medullary Thyroid Carcinoma - History of pancreatitis (acute or
chronic) - History of major surgical procedures involving the stomach potentially affecting
absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,
gastric bypass surgery) - Any of the following: myocardial infarction, stroke or
hospitalisation for unstable angina or transient ischaemic attack within the past 180 days
prior to the day of screening and randomisation - Subjects presently classified as being in
New York Heart Association Class IV - Planned coronary, carotid or peripheral artery
revascularisation known on the day of screening - Subjects with alanine aminotransferase
above 2.5 x upper normal limit - Rapidly progressing renal disease (e.g. such as acute
glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (above
2200 mg/24 hours or above 2200 mg/g) - Use of systemic immunosuppressive treatment within
90 days prior to screening - Treatment with any medication for the indication of diabetes
or obesity other than stated in the inclusion criteria in a period of 90 days before the
day of screening. An exception is short-term insulin treatment for acute illness for a
total of below or equal to 14 days - Known hypoglycaemic unawareness and/or recurrent
severe hypoglycaemic episodes as judged by the investigator - Proliferative retinopathy or
maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy
performed within 90 days prior to randomisation - History or presence of malignant
neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma
in situ)
We found this trial at
56
sites
Kingsport, Tennessee 37660
237
mi
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Kingsport, TN
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Aalborg,
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Albany, New York 12208
513
mi
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Albany, NY
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Amarillo, Texas 79106
1078
mi
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Amarillo, TX
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Asheboro, North Carolina 27203
342
mi
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Asheboro, NC
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Atlanta, Georgia 30318
436
mi
from 43215
Atlanta, GA
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Avon, Indiana 46123
179
mi
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Avon, IN
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Baltimore, Maryland 21229
340
mi
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Baltimore, MD
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Bermuda Dunes, California 92203
1876
mi
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Bermuda Dunes, CA
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Buckley, Michigan 49620
341
mi
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Buckley, MI
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Clearwater, Florida 33756
830
mi
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Clearwater, FL
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Concord, California 94520
2081
mi
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Concord, CA
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Cooper City, Florida 33024
973
mi
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Cooper City, FL
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Costa Mesa, California 92627
1965
mi
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Costa Mesa, CA
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Dallas, Texas 75231
905
mi
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Dallas, TX
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Danbury, Connecticut 06810
510
mi
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Danbury, CT
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65
mi
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Dayton, OH
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Delaware, Ohio 43015
23
mi
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Delaware, OH
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Fargo, North Dakota 58122
837
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Fargo, ND
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Franklin, Indiana 46131
114
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Franklin, IN
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Franklin, Ohio 45005
73
mi
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Franklin, OH
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Fresno, California 93702
1988
mi
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Fresno, CA
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Gurnee, Illinois 60031
303
mi
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Gurnee, IL
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Houston, Texas 77030
995
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Houston, TX
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Jacksonville, Florida 32207
672
mi
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Jacksonville, FL
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La Jolla, California 92037
1954
mi
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La Jolla, CA
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Lawrenceville, Georgia 30046
418
mi
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Lawrenceville, GA
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Lebanon, New Hampshire 03756
609
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Lebanon, NH
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Marietta, Georgia 30060
423
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Marietta, GA
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Miami Lakes, Florida 33016
983
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Miami Lakes, FL
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Midland, Texas 79707
1195
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Midland, TX
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Murrells Inlet, South Carolina 29576
494
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Murrells Inlet, SC
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Myrtle Beach, South Carolina 29572
490
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Myrtle Beach, SC
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Nashua, New Hampshire 03063
629
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Nashua, NH
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New Hyde Park, New York 11042
494
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New Hyde Park, NY
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New Port Richey, Florida 34652
809
mi
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New Port Richey, FL
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Norman, Oklahoma 73069
853
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Norman, OK
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Northport, New York 11768
512
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Northport, NY
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Norwalk, Connecticut 06851
510
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Norwalk, CT
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Olympia, Washington 98502
2033
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Olympia, WA
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Omaha, Nebraska 68114
682
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Omaha, NE
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Orlando, Florida 32804
792
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Orlando, FL
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Palm Harbor, Florida 34684
821
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Pembroke Pines, Florida 33026
978
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Richmond, Virginia 23219
342
mi
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Richmond, VA
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Roswell, Georgia 30076
414
mi
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Roswell, GA
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San Antonio, Texas 78224
1138
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San Antonio, TX
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San Ramon, California 94583
2084
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Slidell, Louisiana 70461
770
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Slidell, LA
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Teaneck, New Jersey 07666
478
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Tuscumbia, Alabama 35674
443
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Tuscumbia, AL
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Waterbury, Connecticut 06708
531
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Waterbury, CT
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West Seneca, New York 14224
295
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West Seneca, NY
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Whiteville, North Carolina 28472
455
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Wilmington, North Carolina 28401
485
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Wilmington, NC
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Winchester, Virginia 22601
264
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Winchester, VA
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