Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:February 15, 2016
End Date:March 28, 2018

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This trial is conducted globally. The aim of the trial is to investigate efficacy and
long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.


Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed
consent For Japan only: Male or female, age at least 20 years at the time of signing
informed consent - Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days
prior to day of screening - HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol)
(both inclusive). - Stable daily dose of metformin (equal or above 1500 mg or maximum
tolerated dose as documented in subject medical record) alone or in combination with SU (=
half of the maximum approved dose according to local label or maximum tolerated dose as
documented in subject medical record) within 90 days prior to the day of screening
Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant
or is of child-bearing potential and not using adequate contraceptive methods (adequate
contraceptive measures as required by local regulation or practice).For certain specific
countries: Additional specific requirements apply - 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) - Any of the following: myocardial
infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack
within the past 180 days prior to the day of screening - Subjects presently classified as
being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or
peripheral artery revascularisation known on the day of screening. - Renal impairment
defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m^2 as per
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) - History or presence of
malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and
in-situ carcinomas)
We found this trial at
85
sites
Albuquerque, New Mexico 87102
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Amarillo, Texas 79106
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Anniston, Alabama 36207
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Avon, Indiana 46123
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Avon, IN
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Birmingham, Alabama 35215
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Bristol, Tennessee 37620
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Bristol, TN
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Butte, Montana 59701
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Butte, MT
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Caba,
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Carmichael, California 95608
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Carmichael, CA
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Charlotte, North Carolina 28277
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Charlotte, NC
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Cincinnati, Ohio 45229
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Columbus, Ohio 43205
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Coronado, California 92118
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Coronado, CA
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Corvallis, Oregon 97330
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Corvallis, OR
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Dallas, Texas 75231
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Denver, Colorado 80220
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Denver, CO
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Encino, California 91436
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Encino, CA
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Fargo, North Dakota 58122
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Fargo, ND
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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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Gaffney, South Carolina 29341
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Glendale, Arizona 85306
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Glendale, AZ
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Greer, South Carolina 29651
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Gurnee, Illinois 60031
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High Point, North Carolina 27265
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High Point, NC
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Honolulu, Hawaii 96814
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Honolulu, HI
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Houston, Texas 77030
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Houston, TX
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Humboldt, Tennessee 38343
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Jackson, Tennessee 38305
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Jackson, TN
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Jefferson City, Missouri 65109
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Jersey Shore, Pennsylvania 17740
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Kissimmee, Florida 34744
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Lexington, Kentucky 40503
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Little Rock, Arkansas 72202
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Longview, Texas 75605
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Los Alamitos, California 90720
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Los Alamitos, CA
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Louisville, Kentucky 40213
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Louisville, KY
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Marietta, Georgia 30060
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Marietta, GA
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Maumee, OH
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McMurray, Pennsylvania 15317
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Meridian, Idaho 83646
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Metairie, Louisiana 70002
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Milwaukee, Wisconsin 53209
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Murray, UT
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Natchitoches, Louisiana 71457
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New Port Richey, Florida 34652
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New Windsor, New York 12553
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New Windsor, NY
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Norman, Oklahoma 73069
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Norman, OK
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Olympia, Washington 98502
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Olympia, WA
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Paducah, Kentucky 42003
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Palm Harbor, Florida 34684
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Palm Springs, California 92262
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Park City, Kansas 67219
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Pelzer, South Carolina 29669
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Peoria, Illinois 61615
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Perry, Georgia 31069
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Plantation, Florida 33324
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Port Charlotte, Florida 33952
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Poway, California 92064
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Renton, Washington 98057
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Richmond, Virginia 23219
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Rochester, New York 14609
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Rockville, Maryland 20852
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San Antonio, Texas 78224
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Shreveport, Louisiana 71105
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South Burlington, Vermont 05403
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Spokane, Washington 99202
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Spring Hill, Florida 34609
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Statesville, North Carolina 28625
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Sterling Heights, Michigan 48310
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Sugar Land, Texas 77479
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Summerville, South Carolina 29485
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Tampa, Florida 33612
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Teaneck, New Jersey 07666
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Toledo, OH
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Trenton, New Jersey 08611
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Tuscumbia, Alabama 35674
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Waco, TX
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Walnut Creek, California 94598
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Waltham, Massachusetts 02453
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West Seneca, New York 14224
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Whiteville, North Carolina 28472
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Wilmington, North Carolina 28401
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