Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:10/12/2018
Start Date:September 20, 2016
End Date:December 8, 2017

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Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only.

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 mellitus treated with
diet and exercise only.


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.For Japan only: Male or female,
age above or equal to 20 years at the time of signing informed consent. For Algeria only:
Male or female, age above or equal to 19 years at the time of signing informed consent -
Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening -
HbA1c (glycosylated haemoglobin) between 7.0-9.5% (53-80 mmol/mol) (both inclusive) -
Treatment with diet and exercise for at least 30 days prior to 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 an adequate contraceptive method (adequate
contraceptive measure as required by local regulation or practice) For Japan only: Adequate
contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner),
intrauterine device, sponge, spermicide or oral contraceptives.For Czech Republic only:
Adequate contraceptive measures are always one highly reliable method (such as intrauterine
device, sterilisation of one of the partners, hormonal birth control methods) plus one
supplementary barrier method (such as condom, diaphragm) with a spermicide. In justified
cases, this combination may be replaced with a double-barrier method with a spermicide.
Total sexual abstinence may also be considered contraception. (Please note: hormonal
contraception should always be discussed with a gynaecologist) - 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
carcinomas - 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 - Renal
impairment defined as estimated glomerular filtration rate below 60 mL/min/1.73 m^2 as per
Chronic Kidney Disease Epidemiology Collaboration formula - Treatment with any medication
for the indication of diabetes or obesity 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 - 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 in-situ carcinomas)
We found this trial at
52
sites
Philadelphia, Pennsylvania 19104
270
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Philadelphia, PA
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?
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Algiers,
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Asheboro, North Carolina 27203
655
mi
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Asheboro, NC
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Blackfoot, Idaho 83221
2070
mi
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Blackfoot, ID
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Bountiful, Utah 84010
2088
mi
from 02139
Bountiful, UT
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Brooklyn, New York 11215
389
mi
from 02139
Brooklyn, NY
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Charlotte, North Carolina 28277
719
mi
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Charlotte, NC
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Cincinnati, Ohio 45229
733
mi
from 02139
Cincinnati, OH
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Dallas, Texas 75231
1541
mi
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Dallas, TX
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Doral, Florida 33166
1257
mi
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Doral, FL
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Elkhorn, Nebraska 68022
1291
mi
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Elkhorn, NE
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Fargo, North Dakota 58122
1294
mi
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Fargo, ND
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Greensboro, North Carolina 27408
635
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from 02139
Greensboro, NC
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Hialeah, Florida 33012
1253
mi
from 02139
Hialeah, FL
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Honolulu, Hawaii 96814
5078
mi
from 02139
Honolulu, HI
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Houston, Texas 77030
1605
mi
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Houston, TX
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Hyattsville, Maryland 20782
386
mi
from 02139
Hyattsville, MD
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Kalamazoo, Michigan 49009
742
mi
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Kalamazoo, MI
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Lancaster, California 93534
2563
mi
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Lancaster, CA
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Los Angeles, California 90027
2588
mi
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Los Angeles, CA
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Louisville, Kentucky 40213
821
mi
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Louisville, KY
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Mesquite, Texas 75149
1538
mi
from 02139
Mesquite, TX
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Metairie, Louisiana 70002
1357
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Metairie, LA
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Miami, Florida 33136
1256
mi
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Miami, FL
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Montclair, California 91763
2559
mi
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Montclair, CA
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Muncie, Indiana 47304
755
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Muncie, IN
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2271
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Nampa, ID
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Norfolk, Virginia 23510
470
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Norfolk, VA
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Norman, Oklahoma 73069
1494
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Norman, OK
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North Hollywood, California 91606
2591
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North Hollywood, CA
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Oklahoma City, Oklahoma 73112
1490
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Oklahoma City, OK
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Palm Harbor, Florida 34684
1183
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Palm Harbor, FL
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Pembroke Pines, Florida 33026
1242
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Pembroke Pines, FL
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Port Charlotte, Florida 33952
1230
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Port Charlotte, FL
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Richmond, Virginia 23219
472
mi
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Richmond, VA
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Riverside, California 92506
2548
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Riverside, CA
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Rochester, Michigan 48307
612
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Rochester, MI
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Salem, Virginia 24153
467
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Salem, VA
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San Antonio, Texas 78224
1763
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San Antonio, TX
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San Diego, California 92111
2576
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San Diego, CA
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San Jose, California 95148
2689
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San Jose, CA
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San Mateo, California 94401
2692
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San Mateo, CA
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Skokie, Illinois 60077
851
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Skokie, IL
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Spartanburg, South Carolina 29303
775
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Spartanburg, SC
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Spring Hill, Florida 34609
1073
mi
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Spring Hill, FL
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Sugar Land, Texas 77479
1620
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Sugar Land, TX
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Tampa, Florida 33612
1175
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Tampa, FL
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Troy, Michigan 48098
758
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Troy, MI
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1614
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Waco, TX
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West Seneca, New York 14224
392
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West Seneca, NY
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Willoughby Hills, Ohio 44094
532
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Willoughby Hills, OH
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Woodstock, Georgia 30189
923
mi
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Woodstock, GA
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