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
Norfolk, Virginia 23510
423
mi
from 43215
Norfolk, VA
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?
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Algiers,
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Asheboro, North Carolina 27203
342
mi
from 43215
Asheboro, NC
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Blackfoot, Idaho 83221
1523
mi
from 43215
Blackfoot, ID
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Bountiful, Utah 84010
1512
mi
from 43215
Bountiful, UT
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Brooklyn, New York 11215
280
mi
from 43215
Brooklyn, NY
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Charlotte, North Carolina 28277
348
mi
from 43215
Charlotte, NC
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Cincinnati, Ohio 45229
95
mi
from 43215
Cincinnati, OH
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Doral, Florida 33166
989
mi
from 43215
Doral, FL
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Elkhorn, Nebraska 68022
698
mi
from 43215
Elkhorn, NE
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Fargo, North Dakota 58122
837
mi
from 43215
Fargo, ND
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Greensboro, North Carolina 27408
321
mi
from 43215
Greensboro, NC
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Hialeah, Florida 33012
987
mi
from 43215
Hialeah, FL
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Honolulu, Hawaii 96814
4501
mi
from 43215
Honolulu, HI
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Houston, Texas 77030
995
mi
from 43215
Houston, TX
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Hyattsville, Maryland 20782
331
mi
from 43215
Hyattsville, MD
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Kalamazoo, Michigan 49009
211
mi
from 43215
Kalamazoo, MI
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Lancaster, California 93534
1950
mi
from 43215
Lancaster, CA
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Los Angeles, California 90027
1973
mi
from 43215
Los Angeles, CA
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Louisville, Kentucky 40213
189
mi
from 43215
Louisville, KY
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Mesquite, Texas 75149
903
mi
from 43215
Mesquite, TX
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Metairie, Louisiana 70002
796
mi
from 43215
Metairie, LA
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Miami, Florida 33136
992
mi
from 43215
Miami, FL
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Montclair, California 91763
1942
mi
from 43215
Montclair, CA
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Muncie, Indiana 47304
125
mi
from 43215
Muncie, IN
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1734
mi
from 43215
Nampa, ID
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Norman, Oklahoma 73069
853
mi
from 43215
Norman, OK
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North Hollywood, California 91606
1976
mi
from 43215
North Hollywood, CA
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Oklahoma City, Oklahoma 73112
849
mi
from 43215
Oklahoma City, OK
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Palm Harbor, Florida 34684
821
mi
from 43215
Palm Harbor, FL
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Pembroke Pines, Florida 33026
978
mi
from 43215
Pembroke Pines, FL
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Philadelphia, Pennsylvania 19104
414
mi
from 43215
Philadelphia, PA
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Port Charlotte, Florida 33952
899
mi
from 43215
Port Charlotte, FL
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Richmond, Virginia 23219
342
mi
from 43215
Richmond, VA
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Riverside, California 92506
1929
mi
from 43215
Riverside, CA
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Rochester, Michigan 48307
187
mi
from 43215
Rochester, MI
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Salem, Virginia 24153
256
mi
from 43215
Salem, VA
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San Antonio, Texas 78224
1138
mi
from 43215
San Antonio, TX
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San Diego, California 92111
1951
mi
from 43215
San Diego, CA
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San Jose, California 95148
2109
mi
from 43215
San Jose, CA
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San Mateo, California 94401
2108
mi
from 43215
San Mateo, CA
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Skokie, Illinois 60077
285
mi
from 43215
Skokie, IL
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Spartanburg, South Carolina 29303
351
mi
from 43215
Spartanburg, SC
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Spring Hill, Florida 34609
700
mi
from 43215
Spring Hill, FL
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Sugar Land, Texas 77479
1009
mi
from 43215
Sugar Land, TX
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Tampa, Florida 33612
823
mi
from 43215
Tampa, FL
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Troy, Michigan 48098
303
mi
from 43215
Troy, MI
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983
mi
from 43215
Waco, TX
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West Seneca, New York 14224
295
mi
from 43215
West Seneca, NY
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Willoughby Hills, Ohio 44094
140
mi
from 43215
Willoughby Hills, OH
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Woodstock, Georgia 30189
413
mi
from 43215
Woodstock, GA
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