Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:9/12/2018
Start Date:September 21, 2015
End Date:October 13, 2016

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This trial is conducted globally. The aim of this trial is to investigate dose-finding of
semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects
with type 2 diabetes


Inclusion Criteria:

- Male or female, age at least 18 years at the time of signing informed consent.

- Subjects should be on stable diabetes treatment consisting of diet and exercise with
or without metformin (at least 1500 mg daily or maximum tolerated dose documented in
the patient medical record) for at least 90 days prior to screening

- HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)

- BMI: 25.0 - 40.0 kg/m^2 (both inclusive)

Exclusion Criteria:

- Simultaneous participation in any other clinical trial of an investigational medicinal
product

- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using adequate contraceptive methods throughout the
trial including the 7 weeks follow-up period (adequate contraceptive measures as
required by local regulation or practice). Germany: Only highly effective methods of
birth control are accepted (i.e. one that results in less than 1% per year failure
rate when used consistently and correctly such as implants, injectables, combined oral
contraceptives, some intrauterine device), or sexual abstinence or vasectomised
partner. United Kingdom: Adequate contraceptive measures are defined as established
use of oral, injected or implanted hormonal methods of contraception, placement of an
intrauterine device or intrauterine system, barrier methods of contraception (condom
or occlusive cap with spermicidal foam/gel/film/cream/suppository), female
sterilisation, male sterilisation (where partner is sole partner of subject), or true
abstinence (when in line with preferred and usual lifestyle)

- 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 screening (an exception
is short-term insulin treatment for acute illnesses for a total of below or equal to
14 days)

- Anticipated initiation or change in concomitant medications (for more than 14
consecutive days or on an frequent basis) known to affect weight or glucose metabolism
(e.g. orlistat, thyroid hormones, corticosteroids)

- History of pancreatitis (acute or chronic)

- Screening calcitonin above or equal to 50 ng/L

- Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary
Thyroid Carcinoma (MTC)

- Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m^2
as per CKD-EPI (Chronic Kidney Disease Epidemiology)

- Within the past 180 days before screening any of the following: Myocardial infarction,
stroke or hospitalisation for unstable angina and/or transient ischemic attack

- Currently planned coronary, carotid or peripheral artery revascularisation

- Patients presently classified as being in New York Heart Association (NYHA) Class III
or IV
We found this trial at
76
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Pembroke Pines, Florida 33026
978
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Arlington, Texas 76012
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Atlanta, Georgia 30318
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Austin, Texas 78731
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Belzoni, Mississippi 39038
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Birmingham, Alabama 35215
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Boca Raton, Florida 33433
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Boston, Massachusetts 02115
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Bountiful, Utah 84010
1512
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Bridgeton, Missouri 63044
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Bristol, Tennessee 37620
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Buckley, Michigan 49620
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Carrollton, Texas 75007
906
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Charleston, South Carolina 29407
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Chattanooga, Tennessee 37404
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Cincinnati, Ohio 45229
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Clinton, Utah 84015
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Coronado, California 92118
1953
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Corvallis, Oregon 97330
2060
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Crestview Hills, Kentucky 41017
105
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Dallas, Texas 75231
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Delaware, Ohio 43015
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Downingtown, Pennsylvania 19335
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Elkhorn, Nebraska 68022
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Evanston, Illinois 60201
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Evansville, Indiana 47714
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Gainesville, Florida 32608
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4617
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Graz,
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Hartford, Connecticut 06105
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Hialeah, Florida 33012
987
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Hodges, South Carolina 29653
394
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Hopewell Junction, New York 12533
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Houston, Texas 77030
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Indian Land, South Carolina 29707
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Johnson City, Tennessee 37604
256
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Kalispell, Montana 59901
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Kettering, Ohio 45429
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Kingsport, Tennessee 37660
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Lancaster, California 93534
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Las Vegas, Nevada 89128
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Lawrenceville, New Jersey 08648
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Louisville, Kentucky 40213
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Madisonville, Kentucky 42431
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Marietta, Georgia 30060
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Marrero, Louisiana 70072
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Media, Pennsylvania 19063
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Memphis, Tennessee 38119
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Miami, Florida 33136
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Missouri City, Texas 77459
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Mount Pleasant, South Carolina 29464
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Nashville, Tennessee 37203
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New Braunfels, Texas 78130
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Newton, Kansas 67114
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Oklahoma City, Oklahoma 73112
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Ponte Vedra, Florida 32081
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Renton, Washington 98057
2001
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Richmond, Virginia 23219
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Riverside, California 92506
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Riverton, Utah 84065
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Rockville, Maryland 20852
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Slidell, Louisiana 70461
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Smithfield, Pennsylvania 15478
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Spokane, Washington 99202
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Statesville, North Carolina 28625
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Sugar Land, Texas 77479
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Tustin, California 92780
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Uniontown, Pennsylvania 15401
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Van Nuys, California 91405
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Virginia Beach, Virginia 23454
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Vista, California 92083
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Winchester, Virginia 22601
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