A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:50 - Any
Updated:11/16/2018
Start Date:January 17, 2017
End Date:September 25, 2018

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This trial is conducted globally. The aim of the trial is to investigate the cardiovascular
safety of oral semaglutide in subjects with type 2 diabetes.


Inclusion Criteria:

- Male or female diagnosed with type 2 diabetes

- Age at least 50 years at screening and presence of cardiovascular disease, or age at
least 60 years at screening and presence of at least one cardiovascular risk factor

Exclusion Criteria:

- Current or previous (within 90 days prior to screening) treatment with any GLP-1
(glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor
or pramlintide

- Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary
thyroid carcinoma (MTC)

- 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)

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

- Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening

- Any of the following: myocardial infarction, stroke or hospitalisation for unstable
angina or transient ischaemic attack within the past 60 days prior to screening

- Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment
(corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73
m^2)

- 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
62
sites
Dallas, Texas 75231
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Albany, New York 12208
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Anderson, South Carolina 29621
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Anderson, SC
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Annaba,
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Arlington, Texas 76012
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Asheville, North Carolina 28801
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Asheville, NC
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Austin, Texas 78731
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Beaver, Pennsylvania 15009
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Beaver, PA
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Boca Raton, Florida 33433
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Canton, Michigan 48187
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Canton, MI
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Chattanooga, Tennessee 37404
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Cleveland, Ohio 44106
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Columbus, Ohio 43205
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Columbus, OH
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Concord, California 94520
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Concord, CA
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Council Bluffs, Iowa 51501
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Council Bluffs, IA
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Fargo, North Dakota 58122
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Fargo, ND
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Greenville, North Carolina 27834
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Greenville, NC
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Honolulu, Hawaii 96814
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Honolulu, HI
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Huntington Beach, California 92648
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Huntington Beach, CA
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Hurst, TX
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Kingsport, Tennessee 37660
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Knoxville, Tennessee 37938
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La Jolla, California 92037
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La Mesa, California 91942
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Lancaster, California 93534
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Las Vegas, Nevada 89128
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Lexington, Kentucky 40503
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Little Rock, Arkansas 72202
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Louisville, Kentucky 40213
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Maumee, OH
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Michigan City, Indiana 46360
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Michigan City, IN
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Midland, Texas 79707
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Moncks Corner, South Carolina 29461
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Monroe, Louisiana 71203
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Monterey, California 93940
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Muncie, Indiana 47304
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Myrtle Beach, South Carolina 29572
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Nashua, New Hampshire 03063
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Nashville, Tennessee 37203
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New Port Richey, Florida 34652
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Norfolk, Virginia 23510
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North Massapequa, New York 11758
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Omaha, Nebraska 68114
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Philadelphia, Pennsylvania 19104
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Roswell, Georgia 30076
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Round Rock, Texas 78681
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San Antonio, Texas 78224
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San Diego, California 92111
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San Ramon, California 94583
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Savannah, Georgia 31406
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Searcy, Arkansas 72143
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Slidell, Louisiana 70461
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South Burlington, Vermont 05403
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Spartanburg, South Carolina 29303
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Springfield, Illinois 62702
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Troy, Michigan 48098
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Ventura, California 93003
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Waco, TX
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Westfield, New York 14787
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Wilmington, North Carolina 28401
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Winchester, Virginia 22601
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