Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes



Status:Completed
Conditions:Obesity Weight Loss, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:12/31/2017
Start Date:June 1, 2011
End Date:January 25, 2013

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Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the potential of liraglutide to induce and maintain
weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added
onto subject's pre-trial background diabetes treatment of either diet and exercise only or
single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or
glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration
of the trial will be 56 weeks followed by a 12 week observational follow-up period.


Inclusion Criteria:

- Informed consent obtained

- Subjects diagnosed with type 2 diabetes and treated with either diet and exercise
alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of
the previously mentioned compounds

- HbA1c 7.0-10.0% (both inclusive)

- Body Mass Index (BMI) at least 27.0 kg/m^2

- Stable body weight

- Preceding failed dietary effort

Exclusion Criteria:

- Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl
peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months

- Known proliferative retinopathy or maculopathy

- History of acute or chronic pancreatitis

- Obesity induced by drug treatment

- Use of approved weight lowering pharmacotherapy

- Previous surgical treatment of obesity

- History of major depressive disorder or suicide attempt

- Uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and/or
diastolic blood pressure above or equal to 100 mmHg)

- Screening calcitonin of 50 ng/L or above

- Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial
medullary thyroid carcinoma (FMTC)

- Personal history of non-familial medullary thyroid carcinoma
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61
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Lexington, Kentucky 40503
1879
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Albany, New York 12208
2438
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Anderson, South Carolina 29621
2008
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Arvada, Colorado 80005
815
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Asheville, North Carolina 28801
2002
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Atlanta, Georgia 30318
1919
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Austin, Texas 78731
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Bondy,
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Bristol, Tennessee 37620
2015
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Brooksville, Florida 34601
2126
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Chattanooga, Tennessee 37404
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Chicago, Illinois 60612
1728
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Cincinnati, Ohio 45229
1881
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Clearwater, Florida 33756
2117
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920 Massachusetts Avenue Northwest
Columbia, Maryland 21045
2281
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Columbus, Georgia 31904
1902
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Concord, California 94520
353
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Dallas, Texas 75231
1225
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1894
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Dayton, OH
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Endwell, New York 13760
2325
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Greensboro, North Carolina 27408
2151
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Hickory, North Carolina 28602
2069
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Hollywood, Florida 33024
2318
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Honolulu, Hawaii 96814
2572
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Hyattsville, Maryland 20782
2285
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Jonesboro, Arkansas 72401
1546
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Kissimmee, Florida 34744
2188
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Lawrenceville, New Jersey 08648
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Long Beach, California 90807
19
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Los Angeles, California 90027
16
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Louisville, Kentucky 40213
1815
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Meridian, Idaho 83646
666
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Minneapolis, Minnesota 55404
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Mission Hills, California 91345
28
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Moncks Corner, South Carolina 29461
2174
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Morehead City, North Carolina 28557
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Nashville, Tennessee 37203
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New Orleans, Louisiana 70112
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Newport News, Virginia 23606
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Oklahoma City, Oklahoma 73112
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Olympia, Washington 98502
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Peoria, Arizona 85381
333
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Philadelphia, Pennsylvania 19104
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Plantation, Florida 33324
2308
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Raleigh, North Carolina 27610
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Roswell, Georgia 30076
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Saint George, Utah 84790
325
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Saint Louis, Missouri 63110
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Salisbury, North Carolina 28144
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Salt Lake City, Utah 84132
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San Antonio, Texas 78224
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Southfield, Michigan 48034
1958
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Spring Valley, California 91978
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Springfield, Illinois 62702
1610
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Tampa, Florida 33612
2134
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Toms River, New Jersey 08755
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Topeka, Kansas 66606
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Tustin, California 92780
25
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Vestavia Hills, Alabama 35209
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Wilmington, North Carolina 28401
2275
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Winston-Salem, North Carolina 27103
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