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
Pembroke Pines, Florida 33026
2719
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Pembroke Pines, FL
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Arlington, Texas 76012
1667
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Atlanta, Georgia 30318
2179
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Atlanta, GA
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Austin, Texas 78731
1770
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Austin, TX
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Belzoni, Mississippi 39038
1930
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Belzoni, MS
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Birmingham, Alabama 35215
2077
mi
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Birmingham, AL
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Boca Raton, Florida 33433
2708
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Boca Raton, FL
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Boston, Massachusetts 02115
2484
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Boston, MA
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Bountiful, Utah 84010
695
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Bridgeton, Missouri 63044
1706
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Bristol, Tennessee 37620
2166
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Bristol, TN
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Buckley, Michigan 49620
1754
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Buckley, MI
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Carrollton, Texas 75007
1665
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Carrollton, TX
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Charleston, South Carolina 29407
2419
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Chattanooga, Tennessee 37404
2085
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Chattanooga, TN
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Cincinnati, Ohio 45229
1966
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Cincinnati, OH
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Clinton, Utah 84015
676
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Clinton, UT
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Coronado, California 92118
1067
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Coronado, CA
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Corvallis, Oregon 97330
216
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Corvallis, OR
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Crestview Hills, Kentucky 41017
1966
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Crestview Hills, KY
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Dallas, Texas 75231
1677
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Dallas, TX
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Delaware, Ohio 43015
1994
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Delaware, OH
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Downingtown, Pennsylvania 19335
2346
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Downingtown, PA
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1998
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Dublin, OH
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Elkhorn, Nebraska 68022
1352
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Elkhorn, NE
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Evanston, Illinois 60201
1725
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Evanston, IL
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Evansville, Indiana 47714
1868
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Evansville, IN
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Gainesville, Florida 32608
2453
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Gainesville, FL
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5416
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Graz,
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Hartford, Connecticut 06105
2429
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Hialeah, Florida 33012
2724
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Hialeah, FL
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Hodges, South Carolina 29653
2254
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Hodges, SC
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Hopewell Junction, New York 12533
2383
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Hopewell Junction, NY
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Houston, Texas 77030
1892
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Houston, TX
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Indian Land, South Carolina 29707
?
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Indian Land, SC
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Johnson City, Tennessee 37604
2170
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Johnson City, TN
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Kalispell, Montana 59901
373
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Kalispell, MT
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Kettering, Ohio 45429
1963
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Kettering, OH
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Kingsport, Tennessee 37660
2150
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Lancaster, California 93534
919
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Lancaster, CA
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Las Vegas, Nevada 89128
868
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Las Vegas, NV
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Lawrenceville, New Jersey 08648
2382
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Louisville, Kentucky 40213
1944
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Madisonville, Kentucky 42431
1893
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Marietta, Georgia 30060
2163
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Marrero, Louisiana 70072
2101
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Marrero, LA
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1967
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Mason, OH
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Media, Pennsylvania 19063
2364
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Media, PA
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Memphis, Tennessee 38119
1876
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Miami, Florida 33136
2730
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Missouri City, Texas 77459
1891
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Mount Pleasant, South Carolina 29464
2426
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Nashville, Tennessee 37203
1971
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New Braunfels, Texas 78130
1786
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Newton, Kansas 67114
1420
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Newton, KS
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Oklahoma City, Oklahoma 73112
1523
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Ponte Vedra, Florida 32081
2469
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Renton, Washington 98057
11
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Richmond, Virginia 23219
2350
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Riverside, California 92506
979
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Riverton, Utah 84065
711
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Rockville, Maryland 20852
2312
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San Antonio, Texas 78224
1787
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Slidell, Louisiana 70461
2096
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Smithfield, Pennsylvania 15478
2162
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Spokane, Washington 99202
231
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Statesville, North Carolina 28625
2257
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Sugar Land, Texas 77479
1887
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Tustin, California 92780
988
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Uniontown, Pennsylvania 15401
2163
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Van Nuys, California 91405
950
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Virginia Beach, Virginia 23454
2445
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Vista, California 92083
1032
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1726
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Waco, TX
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Walnut Creek, California 94598
664
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Winchester, Virginia 22601
2259
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Winchester, VA
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