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
We found this trial at
61
sites
Spring Valley, California 91978
2014
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Spring Valley, CA
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Albany, New York 12208
513
mi
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Albany, NY
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Anderson, South Carolina 29621
377
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Anderson, SC
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Arvada, Colorado 80005
1166
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Arvada, CO
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Asheville, North Carolina 28801
302
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Asheville, NC
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Atlanta, Georgia 30318
436
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Atlanta, GA
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Austin, Texas 78731
1065
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Austin, TX
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?
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Bondy,
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Bristol, Tennessee 37620
237
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Bristol, TN
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Brooksville, Florida 34601
789
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Brooksville, FL
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Chattanooga, Tennessee 37404
362
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Chattanooga, TN
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Chicago, Illinois 60612
274
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from 43215
Chicago, IL
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Cincinnati, Ohio 45229
95
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Cincinnati, OH
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Clearwater, Florida 33756
830
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Clearwater, FL
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920 Massachusetts Avenue Northwest
Columbia, Maryland 21045
328
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from 43215
Columbia, MD
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Columbus, Georgia 31904
529
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Columbus, GA
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Concord, California 94520
2081
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Concord, CA
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Dallas, Texas 75231
905
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Dallas, TX
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65
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Dayton, OH
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Endwell, New York 13760
393
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Endwell, NY
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Greensboro, North Carolina 27408
321
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Greensboro, NC
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Hickory, North Carolina 28602
306
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Hickory, NC
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Hollywood, Florida 33024
978
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Hollywood, FL
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Honolulu, Hawaii 96814
4501
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Honolulu, HI
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Hyattsville, Maryland 20782
331
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Hyattsville, MD
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Jonesboro, Arkansas 72401
506
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Jonesboro, AR
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Kissimmee, Florida 34744
811
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Kissimmee, FL
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Lawrenceville, New Jersey 08648
438
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Lawrenceville, NJ
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Lexington, Kentucky 40503
157
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Lexington, KY
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Long Beach, California 90807
1974
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Long Beach, CA
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Los Angeles, California 90027
1973
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Los Angeles, CA
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Louisville, Kentucky 40213
189
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Louisville, KY
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Meridian, Idaho 83646
1727
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Meridian, ID
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Minneapolis, Minnesota 55404
624
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Minneapolis, MN
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Mission Hills, California 91345
1978
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Mission Hills, CA
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Moncks Corner, South Carolina 29461
496
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Moncks Corner, SC
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Morehead City, North Carolina 28557
500
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Morehead City, NC
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Nashville, Tennessee 37203
333
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Nashville, TN
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New Orleans, Louisiana 70112
797
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New Orleans, LA
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Newport News, Virginia 23606
411
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Newport News, VA
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Oklahoma City, Oklahoma 73112
849
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Oklahoma City, OK
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Olympia, Washington 98502
2033
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Olympia, WA
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Peoria, Arizona 85381
1667
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Peoria, AZ
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Philadelphia, Pennsylvania 19104
414
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Philadelphia, PA
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Plantation, Florida 33324
970
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Plantation, FL
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Raleigh, North Carolina 27610
375
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Raleigh, NC
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Roswell, Georgia 30076
414
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Saint George, Utah 84790
1655
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Saint George, UT
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Saint Louis, Missouri 63110
394
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Saint Louis, MO
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Salisbury, North Carolina 28144
327
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Salisbury, NC
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Salt Lake City, Utah 84132
1513
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San Antonio, Texas 78224
1138
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Southfield, Michigan 48034
173
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Southfield, MI
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Springfield, Illinois 62702
349
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Springfield, IL
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Tampa, Florida 33612
823
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Toms River, New Jersey 08755
467
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Toms River, NJ
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Topeka, Kansas 66606
676
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Topeka, KS
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Tustin, California 92780
1957
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Vestavia Hills, Alabama 35209
496
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Wilmington, North Carolina 28401
485
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Winston-Salem, North Carolina 27103
307
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