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
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Asheboro, North Carolina 27203
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Blackfoot, Idaho 83221
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Bountiful, Utah 84010
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Brooklyn, New York 11215
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Charlotte, North Carolina 28277
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Charlotte, NC
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Dallas, Texas 75231
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Doral, Florida 33166
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Doral, FL
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Elkhorn, Nebraska 68022
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Elkhorn, NE
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Fargo, North Dakota 58122
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Fargo, ND
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Greensboro, North Carolina 27408
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Greensboro, NC
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Hialeah, Florida 33012
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Hialeah, FL
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Honolulu, Hawaii 96814
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Honolulu, HI
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Houston, Texas 77030
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Houston, TX
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Hyattsville, Maryland 20782
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Hyattsville, MD
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Kalamazoo, Michigan 49009
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Kalamazoo, MI
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Lancaster, California 93534
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Lancaster, CA
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Los Angeles, California 90027
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Los Angeles, CA
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Louisville, Kentucky 40213
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Mesquite, Texas 75149
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Mesquite, TX
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Metairie, Louisiana 70002
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Metairie, LA
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Miami, Florida 33136
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Miami, FL
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Montclair, California 91763
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Montclair, CA
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Muncie, Indiana 47304
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Norfolk, Virginia 23510
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Norman, Oklahoma 73069
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North Hollywood, California 91606
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Oklahoma City, Oklahoma 73112
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Palm Harbor, Florida 34684
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Pembroke Pines, Florida 33026
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Philadelphia, Pennsylvania 19104
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Port Charlotte, Florida 33952
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Richmond, Virginia 23219
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Riverside, California 92506
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Rochester, Michigan 48307
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Salem, Virginia 24153
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San Antonio, Texas 78224
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San Diego, California 92111
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San Jose, California 95148
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San Mateo, California 94401
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Skokie, Illinois 60077
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Spartanburg, South Carolina 29303
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Spring Hill, Florida 34609
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Sugar Land, Texas 77479
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Tampa, Florida 33612
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Troy, Michigan 48098
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West Seneca, New York 14224
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Willoughby Hills, Ohio 44094
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Woodstock, Georgia 30189
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