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
San Mateo, California 94401
695
mi
from 98109
San Mateo, CA
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?
mi
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Algiers,
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Asheboro, North Carolina 27203
2310
mi
from 98109
Asheboro, NC
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Blackfoot, Idaho 83221
573
mi
from 98109
Blackfoot, ID
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Bountiful, Utah 84010
695
mi
from 98109
Bountiful, UT
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Brooklyn, New York 11215
2129
mi
from 98109
Brooklyn, NY
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Charlotte, North Carolina 28277
2281
mi
from 98109
Charlotte, NC
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Cincinnati, Ohio 45229
1966
mi
from 98109
Cincinnati, OH
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Dallas, Texas 75231
1677
mi
from 98109
Dallas, TX
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Doral, Florida 33166
2722
mi
from 98109
Doral, FL
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Elkhorn, Nebraska 68022
1352
mi
from 98109
Elkhorn, NE
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Fargo, North Dakota 58122
1194
mi
from 98109
Fargo, ND
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Greensboro, North Carolina 27408
2297
mi
from 98109
Greensboro, NC
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Hialeah, Florida 33012
2724
mi
from 98109
Hialeah, FL
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Honolulu, Hawaii 96814
2679
mi
from 98109
Honolulu, HI
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Houston, Texas 77030
1892
mi
from 98109
Houston, TX
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Hyattsville, Maryland 20782
2324
mi
from 98109
Hyattsville, MD
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Kalamazoo, Michigan 49009
1812
mi
from 98109
Kalamazoo, MI
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Lancaster, California 93534
919
mi
from 98109
Lancaster, CA
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Los Angeles, California 90027
956
mi
from 98109
Los Angeles, CA
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Louisville, Kentucky 40213
1944
mi
from 98109
Louisville, KY
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Mesquite, Texas 75149
1689
mi
from 98109
Mesquite, TX
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Metairie, Louisiana 70002
2092
mi
from 98109
Metairie, LA
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Miami, Florida 33136
2730
mi
from 98109
Miami, FL
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Montclair, California 91763
967
mi
from 98109
Montclair, CA
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Muncie, Indiana 47304
1890
mi
from 98109
Muncie, IN
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397
mi
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Nampa, ID
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Norfolk, Virginia 23510
2430
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from 98109
Norfolk, VA
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Norman, Oklahoma 73069
1538
mi
from 98109
Norman, OK
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North Hollywood, California 91606
952
mi
from 98109
North Hollywood, CA
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Oklahoma City, Oklahoma 73112
1523
mi
from 98109
Oklahoma City, OK
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Palm Harbor, Florida 34684
2507
mi
from 98109
Palm Harbor, FL
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Pembroke Pines, Florida 33026
2719
mi
from 98109
Pembroke Pines, FL
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Philadelphia, Pennsylvania 19104
2371
mi
from 98109
Philadelphia, PA
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Port Charlotte, Florida 33952
2589
mi
from 98109
Port Charlotte, FL
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Richmond, Virginia 23219
2350
mi
from 98109
Richmond, VA
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Riverside, California 92506
979
mi
from 98109
Riverside, CA
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Rochester, Michigan 48307
1919
mi
from 98109
Rochester, MI
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Salem, Virginia 24153
2260
mi
from 98109
Salem, VA
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San Antonio, Texas 78224
1787
mi
from 98109
San Antonio, TX
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San Diego, California 92111
1065
mi
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San Diego, CA
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San Jose, California 95148
661
mi
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San Jose, CA
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Skokie, Illinois 60077
1722
mi
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Skokie, IL
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Spartanburg, South Carolina 29303
2242
mi
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Spartanburg, SC
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Spring Hill, Florida 34609
2435
mi
from 98109
Spring Hill, FL
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Sugar Land, Texas 77479
1887
mi
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Sugar Land, TX
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Tampa, Florida 33612
2522
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Tampa, FL
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Troy, Michigan 48098
1757
mi
from 98109
Troy, MI
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1726
mi
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Waco, TX
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West Seneca, New York 14224
2115
mi
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West Seneca, NY
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Willoughby Hills, Ohio 44094
2030
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Willoughby Hills, OH
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Woodstock, Georgia 30189
2158
mi
from 98109
Woodstock, GA
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