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
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Coronado, California 92118
107
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Coronado, CA
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Albuquerque, New Mexico 87102
650
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Amarillo, Texas 79106
922
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Anniston, Alabama 36207
1838
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Avon, Indiana 46123
1780
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Birmingham, Alabama 35215
1788
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Bristol, Tennessee 37620
2015
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Butte, Montana 59701
872
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Caba,
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Carmichael, California 95608
364
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Charlotte, North Carolina 28277
2101
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Cincinnati, Ohio 45229
1881
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Columbus, Ohio 43205
1960
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Corvallis, Oregon 97330
776
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Dallas, Texas 75231
1225
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Denver, Colorado 80220
818
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Encino, California 91436
28
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Fargo, North Dakota 58122
1416
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Fargo, ND
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Flint, Michigan 48504
1939
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Franklin, Ohio 45005
1891
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Fresno, California 93702
209
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Gaffney, South Carolina 29341
2058
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Glendale, Arizona 85306
336
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Greer, South Carolina 29651
2027
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Gurnee, Illinois 60031
1721
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High Point, North Carolina 27265
1997
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Honolulu, Hawaii 96814
2572
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Honolulu, HI
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Houston, Texas 77030
1357
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Humboldt, Tennessee 38343
1646
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Jackson, Tennessee 38305
1653
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Jefferson City, Missouri 65109
1466
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Jersey Shore, Pennsylvania 17740
2261
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Kissimmee, Florida 34744
2188
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Lexington, Kentucky 40503
1879
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Little Rock, Arkansas 72202
1463
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Longview, Texas 75605
1345
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Los Alamitos, California 90720
18
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Louisville, Kentucky 40213
1815
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Marietta, Georgia 30060
1907
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1931
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McMurray, Pennsylvania 15317
2114
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Meridian, Idaho 83646
666
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Metairie, Louisiana 70002
1649
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Milwaukee, Wisconsin 53209
1729
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565
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Murray, UT
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Natchitoches, Louisiana 71457
1450
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New Port Richey, Florida 34652
2114
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New Windsor, New York 12553
2429
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Norman, Oklahoma 73069
1170
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Olympia, Washington 98502
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Paducah, Kentucky 42003
1659
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Palm Harbor, Florida 34684
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Palm Springs, California 92262
85
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Park City, Kansas 67219
1183
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Pelzer, South Carolina 29669
2017
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Peoria, Illinois 61615
1618
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Perry, Georgia 31069
1974
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1225
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Plantation, Florida 33324
2308
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Port Charlotte, Florida 33952
2181
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Poway, California 92064
95
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Renton, Washington 98057
952
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Richmond, Virginia 23219
2267
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Rochester, New York 14609
2245
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Rockville, Maryland 20852
2275
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San Antonio, Texas 78224
1188
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Shreveport, Louisiana 71105
1405
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South Burlington, Vermont 05403
2469
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Spokane, Washington 99202
939
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Spring Hill, Florida 34609
2089
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Statesville, North Carolina 28625
2093
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Sterling Heights, Michigan 48310
1969
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Sugar Land, Texas 77479
1345
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Summerville, South Carolina 29485
2167
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Tampa, Florida 33612
2134
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Teaneck, New Jersey 07666
2431
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1932
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Trenton, New Jersey 08611
2396
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Tuscumbia, Alabama 35674
1721
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1219
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Walnut Creek, California 94598
354
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Waltham, Massachusetts 02453
2568
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West Seneca, New York 14224
2184
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Whiteville, North Carolina 28472
2231
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Wilmington, North Carolina 28401
2275
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