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
Rochester, Michigan 48307
844
mi
from
Rochester, MI
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?
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from
Algiers,
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Asheboro, North Carolina 27203
1005
mi
from
Asheboro, NC
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Blackfoot, Idaho 83221
849
mi
from
Blackfoot, ID
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Bountiful, Utah 84010
781
mi
from
Bountiful, UT
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Brooklyn, New York 11215
1056
mi
from
Brooklyn, NY
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Charlotte, North Carolina 28277
957
mi
from
Charlotte, NC
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Cincinnati, Ohio 45229
727
mi
from
Cincinnati, OH
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Dallas, Texas 75231
341
mi
from
Dallas, TX
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Doral, Florida 33166
1311
mi
from
Doral, FL
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Elkhorn, Nebraska 68022
258
mi
from
Elkhorn, NE
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Fargo, North Dakota 58122
633
mi
from
Fargo, ND
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Greensboro, North Carolina 27408
1001
mi
from
Greensboro, NC
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Hialeah, Florida 33012
1313
mi
from
Hialeah, FL
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Honolulu, Hawaii 96814
3717
mi
from
Honolulu, HI
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Houston, Texas 77030
572
mi
from
Houston, TX
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Hyattsville, Maryland 20782
1131
mi
from
Hyattsville, MD
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Kalamazoo, Michigan 49009
714
mi
from
Kalamazoo, MI
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Lancaster, California 93534
1149
mi
from
Lancaster, CA
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Los Angeles, California 90027
1169
mi
from
Los Angeles, CA
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Louisville, Kentucky 40213
659
mi
from
Louisville, KY
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Mesquite, Texas 75149
351
mi
from
Mesquite, TX
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Metairie, Louisiana 70002
691
mi
from
Metairie, LA
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Miami, Florida 33136
1320
mi
from
Miami, FL
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Montclair, California 91763
1137
mi
from
Montclair, CA
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Muncie, Indiana 47304
688
mi
from
Muncie, IN
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1057
mi
from
Nampa, ID
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Norfolk, Virginia 23510
1182
mi
from
Norfolk, VA
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Norman, Oklahoma 73069
175
mi
from
Norman, OK
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North Hollywood, California 91606
1173
mi
from
North Hollywood, CA
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Oklahoma City, Oklahoma 73112
158
mi
from
Oklahoma City, OK
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Palm Harbor, Florida 34684
1097
mi
from
Palm Harbor, FL
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Pembroke Pines, Florida 33026
1309
mi
from
Pembroke Pines, FL
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Philadelphia, Pennsylvania 19104
1223
mi
from
Philadelphia, PA
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Port Charlotte, Florida 33952
1178
mi
from
Port Charlotte, FL
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Richmond, Virginia 23219
1111
mi
from
Richmond, VA
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Riverside, California 92506
1124
mi
from
Riverside, CA
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Salem, Virginia 24153
1046
mi
from
Salem, VA
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San Antonio, Texas 78224
576
mi
from
San Antonio, TX
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San Diego, California 92111
1142
mi
from
San Diego, CA
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San Jose, California 95148
1344
mi
from
San Jose, CA
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San Mateo, California 94401
1337
mi
from
San Mateo, CA
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Skokie, Illinois 60077
609
mi
from
Skokie, IL
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Spartanburg, South Carolina 29303
903
mi
from
Spartanburg, SC
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Spring Hill, Florida 34609
1032
mi
from
Spring Hill, FL
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Sugar Land, Texas 77479
575
mi
from
Sugar Land, TX
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Tampa, Florida 33612
1112
mi
from
Tampa, FL
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Troy, Michigan 48098
742
mi
from
Troy, MI
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430
mi
from
Waco, TX
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West Seneca, New York 14224
1059
mi
from
West Seneca, NY
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Willoughby Hills, Ohio 44094
910
mi
from
Willoughby Hills, OH
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Woodstock, Georgia 30189
784
mi
from
Woodstock, GA
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