Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:August 10, 2016
End Date:March 30, 2018

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This trial is conducted globally. The aim of this trial is to investigate efficacy and safety
of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes
Mellitus.


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 at least 20 years at the time of signing
informed consent

- Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of
screening.

- HbA1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive)

- Stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose as
documented in the subject medical record) alone or in combination with a stable daily
dose of a SGLT-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 days
prior to day of screening (fixed-dose combinations are allowed)

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 certain
specific countries: Additional specific requirements apply

- 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 (MEN 2) or Medullary
Thyroid Carcinoma (MTC)

- History of pancreatitis (acute or chronic)

- History of major surgical procedures involving the stomach and potentially affecting
absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,
gastric bypass surgery)

- Any of the following: myocardial infarction (MI), stroke or hospitalisation for
unstable angina or transient ischaemic attack within the past 180 days prior to the
day of screening

- Subjects presently classified as being in New York Heart Association (NYHA) Class IV

- Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening

- Subjects with ALT (alanine aminotransferase) above 2.5 × upper normal limit (UNL)

- Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60
mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula
(CKD-EPI)

- Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria 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 carcinoma in situ)

- History of diabetic ketoacidosis
We found this trial at
38
sites
Miami, Florida 33136
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Miami, FL
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Albany, New York 12208
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Albany, NY
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Arlington, Texas 76012
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Arlington, TX
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Birmingham, Alabama 35215
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Birmingham, AL
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Bristol, Tennessee 37620
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Bristol, TN
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Butte, Montana 59701
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Butte, MT
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Dallas, Texas 75231
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Dallas, TX
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Denver, Colorado 80220
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Denver, CO
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Dublin, OH
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Greensboro, North Carolina 27408
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Greensboro, NC
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Hallandale Beach, Florida 33009
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Hallandale Beach, FL
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Houston, Texas 77030
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Houston, TX
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Jacksonville, Florida 32207
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Jacksonville, FL
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Karlovac,
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Lebanon, New Hampshire 03756
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Lebanon, NH
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Los Alamitos, California 90720
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Los Alamitos, CA
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Maumee, OH
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McMurray, Pennsylvania 15317
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McMurray, PA
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Mineola, New York 11501
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Mineola, NY
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Morganton, North Carolina 28655
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Morganton, NC
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Newport News, Virginia 23606
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Newport News, VA
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Norman, Oklahoma 73069
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Norman, OK
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North Richland Hills, Texas 76180
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North Richland Hills, TX
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Ocala, Florida 34471
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Ocala, FL
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Orlando, Florida 32804
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Orlando, FL
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Ormond Beach, Florida 32174
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Ormond Beach, FL
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Peoria, Illinois 61615
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Peoria, IL
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Richmond, Virginia 23219
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Richmond, VA
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Saint Petersburg, Florida 33713
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Saint Petersburg, FL
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San Antonio, Texas 78224
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San Antonio, TX
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San Diego, California 92111
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San Diego, CA
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Slidell, Louisiana 70461
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Slidell, LA
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Summerville, South Carolina 29485
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Summerville, SC
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Teaneck, New Jersey 07666
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Teaneck, NJ
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Topeka, Kansas 66606
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Topeka, KS
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Virginia Beach, Virginia 23454
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Virginia Beach, VA
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West Palm Beach, Florida 33409
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West Palm Beach, FL
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Wilmington, North Carolina 28401
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from
Wilmington, NC
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