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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Tustin, California 92780
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Albany, New York 12208
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Anderson, South Carolina 29621
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Arvada, Colorado 80005
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Asheville, North Carolina 28801
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Atlanta, Georgia 30318
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Austin, Texas 78731
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Bristol, Tennessee 37620
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Brooksville, Florida 34601
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Chattanooga, Tennessee 37404
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Chicago, Illinois 60612
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Cincinnati, Ohio 45229
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Clearwater, Florida 33756
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920 Massachusetts Avenue Northwest
Columbia, Maryland 21045
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Columbus, Georgia 31904
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Concord, California 94520
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Dallas, Texas 75231
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Endwell, New York 13760
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Greensboro, North Carolina 27408
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Hickory, North Carolina 28602
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Hollywood, Florida 33024
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Honolulu, Hawaii 96814
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Hyattsville, Maryland 20782
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Jonesboro, Arkansas 72401
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Kissimmee, Florida 34744
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Lexington, Kentucky 40503
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Long Beach, California 90807
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Meridian, Idaho 83646
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Minneapolis, Minnesota 55404
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Mission Hills, California 91345
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Moncks Corner, South Carolina 29461
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Morehead City, North Carolina 28557
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Nashville, Tennessee 37203
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Newport News, Virginia 23606
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Saint Louis, Missouri 63110
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Spring Valley, California 91978
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Vestavia Hills, Alabama 35209
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Wilmington, North Carolina 28401
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