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
Bridgeton, Missouri 63044
1562
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Bridgeton, MO
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Arlington, Texas 76012
1205
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Atlanta, Georgia 30318
1919
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Austin, Texas 78731
1212
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Belzoni, Mississippi 39038
1579
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Birmingham, Alabama 35215
1788
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Boca Raton, Florida 33433
2312
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Boca Raton, FL
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Boston, Massachusetts 02115
2576
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Boston, MA
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Bountiful, Utah 84010
578
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Bristol, Tennessee 37620
2015
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Buckley, Michigan 49620
1857
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Buckley, MI
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Carrollton, Texas 75007
1216
mi
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Carrollton, TX
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Charleston, South Carolina 29407
2180
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Chattanooga, Tennessee 37404
1855
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Cincinnati, Ohio 45229
1881
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Clinton, Utah 84015
586
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Coronado, California 92118
107
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Corvallis, Oregon 97330
776
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Crestview Hills, Kentucky 41017
1875
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Dallas, Texas 75231
1225
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Delaware, Ohio 43015
1957
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Delaware, OH
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Downingtown, Pennsylvania 19335
2346
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Downingtown, PA
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1954
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Dublin, OH
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Elkhorn, Nebraska 68022
1286
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Evanston, Illinois 60201
1728
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Evansville, Indiana 47714
1716
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Gainesville, Florida 32608
2104
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6130
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Graz,
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Hartford, Connecticut 06105
2497
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Hialeah, Florida 33012
2314
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Hodges, South Carolina 29653
2033
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Hodges, SC
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Hopewell Junction, New York 12533
2439
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Houston, Texas 77030
1357
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Indian Land, South Carolina 29707
?
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Johnson City, Tennessee 37604
2008
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Kalispell, Montana 59901
994
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Kettering, Ohio 45429
1898
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Kingsport, Tennessee 37660
1994
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Lancaster, California 93534
43
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Las Vegas, Nevada 89128
213
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Lawrenceville, New Jersey 08648
2396
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Louisville, Kentucky 40213
1815
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Madisonville, Kentucky 42431
1719
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Marietta, Georgia 30060
1907
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Marrero, Louisiana 70072
1655
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1890
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Mason, OH
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Media, Pennsylvania 19063
2363
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Memphis, Tennessee 38119
1598
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Miami, Florida 33136
2321
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Missouri City, Texas 77459
1351
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Mount Pleasant, South Carolina 29464
2188
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Nashville, Tennessee 37203
1762
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New Braunfels, Texas 78130
1203
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Newton, Kansas 67114
1183
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Oklahoma City, Oklahoma 73112
1165
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Pembroke Pines, Florida 33026
2314
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Ponte Vedra, Florida 32081
2147
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Renton, Washington 98057
952
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Richmond, Virginia 23219
2267
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Riverside, California 92506
36
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Riverton, Utah 84065
556
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Rockville, Maryland 20852
2275
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San Antonio, Texas 78224
1188
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Slidell, Louisiana 70461
1666
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Smithfield, Pennsylvania 15478
2130
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Spokane, Washington 99202
939
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Statesville, North Carolina 28625
2093
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Sugar Land, Texas 77479
1345
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Tustin, California 92780
25
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Uniontown, Pennsylvania 15401
2134
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Van Nuys, California 91405
26
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Virginia Beach, Virginia 23454
2354
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Vista, California 92083
74
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1219
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Waco, TX
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Walnut Creek, California 94598
354
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Winchester, Virginia 22601
2219
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