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
sites
Riverton, Utah 84065
779
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Riverton, UT
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Arlington, Texas 76012
347
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Arlington, TX
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Atlanta, Georgia 30318
801
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Atlanta, GA
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Austin, Texas 78731
517
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Austin, TX
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Belzoni, Mississippi 39038
519
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Belzoni, MS
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Birmingham, Alabama 35215
684
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Birmingham, AL
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Boca Raton, Florida 33433
1299
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Boca Raton, FL
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Boston, Massachusetts 02115
1442
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Boston, MA
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Bountiful, Utah 84010
781
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Bridgeton, Missouri 63044
407
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Bristol, Tennessee 37620
863
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Bristol, TN
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Buckley, Michigan 49620
784
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Buckley, MI
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Carrollton, Texas 75007
331
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Carrollton, TX
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Charleston, South Carolina 29407
1059
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Charleston, SC
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Chattanooga, Tennessee 37404
721
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Cincinnati, Ohio 45229
727
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Cincinnati, OH
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Clinton, Utah 84015
793
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Coronado, California 92118
1144
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Corvallis, Oregon 97330
1397
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Corvallis, OR
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Crestview Hills, Kentucky 41017
721
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Crestview Hills, KY
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Dallas, Texas 75231
341
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Delaware, Ohio 43015
810
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Downingtown, Pennsylvania 19335
1196
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806
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Dublin, OH
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Elkhorn, Nebraska 68022
258
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Evanston, Illinois 60201
612
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Evansville, Indiana 47714
561
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Gainesville, Florida 32608
1049
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5276
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Graz,
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Hartford, Connecticut 06105
1358
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Hialeah, Florida 33012
1313
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Hialeah, FL
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Hodges, South Carolina 29653
901
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Hopewell Junction, New York 12533
1299
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Hopewell Junction, NY
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Houston, Texas 77030
572
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Houston, TX
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Indian Land, South Carolina 29707
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Johnson City, Tennessee 37604
858
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Kalispell, Montana 59901
1098
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Kettering, Ohio 45429
747
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Kingsport, Tennessee 37660
843
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Lancaster, California 93534
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Las Vegas, Nevada 89128
967
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Lawrenceville, New Jersey 08648
1248
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Louisville, Kentucky 40213
659
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Madisonville, Kentucky 42431
566
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Marietta, Georgia 30060
787
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Marrero, Louisiana 70072
699
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737
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Mason, OH
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Media, Pennsylvania 19063
1213
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Media, PA
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Memphis, Tennessee 38119
480
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Miami, Florida 33136
1320
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Missouri City, Texas 77459
576
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Mount Pleasant, South Carolina 29464
1067
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Nashville, Tennessee 37203
618
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New Braunfels, Texas 78130
556
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Newton, Kansas 67114
33
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Newton, KS
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Oklahoma City, Oklahoma 73112
158
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Pembroke Pines, Florida 33026
1309
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Ponte Vedra, Florida 32081
1073
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Renton, Washington 98057
1402
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Richmond, Virginia 23219
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Riverside, California 92506
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Rockville, Maryland 20852
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San Antonio, Texas 78224
576
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Slidell, Louisiana 70461
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Smithfield, Pennsylvania 15478
978
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Spokane, Washington 99202
1200
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Statesville, North Carolina 28625
945
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Sugar Land, Texas 77479
575
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Tustin, California 92780
1152
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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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430
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Waco, TX
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Walnut Creek, California 94598
1318
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Winchester, Virginia 22601
1065
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