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

Last updated: December 6, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT01272232
NN8022-1922
U1111-1118-7963
2008-002199-88
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent obtained

  • Subjects diagnosed with type 2 diabetes and treated with either diet and exercisealone, metformin, sulphonylurea, glitazone as single agent therapy or a combination ofthe 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

Exclusion Criteria:

  • Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidylpeptidase-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/ordiastolic 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 familialmedullary thyroid carcinoma (FMTC)

  • Personal history of non-familial medullary thyroid carcinoma

Study Design

Total Participants: 846
Study Start date:
June 01, 2011
Estimated Completion Date:
January 25, 2013

Connect with a study center

  • Novo Nordisk Investigational Site

    Bondy, 93143
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    LA ROCHELLE cedex, 17019
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Le Creusot, 71200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanterre, 92014
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Narbonne, 11108
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Pointe À Pitre, 97139
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Herblain, 44800
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Venissieux, 69200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Berlin, 12203
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Dresden, 01309
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Gebhardshain, 57580
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamburg, 22607
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679
    Germany

    Site Not Available

  • empty

    Münster, 48145
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Münster, 48145
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Schkeuditz, 04435
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Stuttgart, 70378
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Wangen, 88239
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Jaipur, Rajasthan 302006
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu 600086
    India

    Site Not Available

  • empty

    Madurai, Tamil Nadu 625 020
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal 700020
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Pune, 411011
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Thriruvananthapuram, 695 032
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Beer Sheva, 84101
    Israel

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  • Novo Nordisk Investigational Site

    Haifa, 35152
    Israel

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  • Novo Nordisk Investigational Site

    Jerusalem, 91120
    Israel

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  • Novo Nordisk Investigational Site

    Rishon Le Zion, 75650
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel Hashomer, 52621
    Israel

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  • Novo Nordisk Investigational Site

    Catanzaro, 88100
    Italy

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  • Novo Nordisk Investigational Site

    Chieti Scalo, 66100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Firenze, 50141
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Forlì, 47100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Latina, 04100
    Italy

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  • Novo Nordisk Investigational Site

    Milano, 20132
    Italy

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  • Novo Nordisk Investigational Site

    Padova, 35143
    Italy

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  • Novo Nordisk Investigational Site

    Perugia, 06126
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Pistoia, 51100
    Italy

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Rio Piedras, 00921
    Puerto Rico

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  • Novo Nordisk Investigational Site

    San Juan, 00921
    Puerto Rico

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  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape 6045
    South Africa

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  • Novo Nordisk Investigational Site

    Bloemfontein, Free State 9301
    South Africa

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    Johannesburg, Gauteng 2194
    South Africa

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  • Novo Nordisk Investigational Site

    Lenasia, Gauteng 1827
    South Africa

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  • Novo Nordisk Investigational Site

    Pretoria, Gauteng 0001
    South Africa

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    Durban, KwaZulu-Natal 4001
    South Africa

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  • Novo Nordisk Investigational Site

    Brits, North West 0250
    South Africa

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    Cape Town, Western Cape 7460
    South Africa

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  • Novo Nordisk Investigational Site

    Granada, 18012
    Spain

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    Madrid, 28034
    Spain

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    Palma de Mallorca, 07010
    Spain

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    Partida De Bacarot, 03114
    Spain

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  • Novo Nordisk Investigational Site

    Sevilla, 41014
    Spain

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  • Novo Nordisk Investigational Site

    Dalby, 240 10
    Sweden

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    Göteborg, 417 17
    Sweden

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  • Novo Nordisk Investigational Site

    Göteborg, 416 65
    Sweden

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  • Novo Nordisk Investigational Site

    Luleå, 972 33
    Sweden

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    Lund, 221 85
    Sweden

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    Stockholm, 141 86
    Sweden

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    Ängelholm, 262 81
    Sweden

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    Örebro, 701 85
    Sweden

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    Taichung, 404
    Taiwan

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    Tainan city, 710
    Taiwan

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    Taoyuan, 333
    Taiwan

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    Ankara, 06100
    Turkey

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    Gaziantep, 27070
    Turkey

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    Hatay, 31040
    Turkey

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    Istanbul, 34096
    Turkey

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    Izmir, 35340
    Turkey

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    Kahramanmaras, 46000
    Turkey

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    Airdrie, ML6 0JS
    United Kingdom

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    Ayr, KA6 6DX
    United Kingdom

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    Bexhill-on-Sea, TN39 4SP
    United Kingdom

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    Birmingham, B9 5SS
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    Bristol, BS10 5NB
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    Cambridge, CB2 2QQ
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    Chester, CH2 1UL
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    Darlington, DL2 1AA
    United Kingdom

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    Leeds, LS25 1AN
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    Leicester, LE5 4PW
    United Kingdom

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  • Novo Nordisk Investigational Site

    London, E1 2EF
    United Kingdom

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    Middlesbrough, TS4 3BW
    United Kingdom

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    Nottingham, NG7 2UH
    United Kingdom

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  • Novo Nordisk Investigational Site

    Plymouth, PL6 8BQ
    United Kingdom

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  • Novo Nordisk Investigational Site

    Rotherham, S651DA
    United Kingdom

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    Swansea, SA6 6NL
    United Kingdom

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  • Novo Nordisk Investigational Site

    Truro, TR1 3LJ
    United Kingdom

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  • Novo Nordisk Investigational Site

    Vestavia Hills, Alabama 35209
    United States

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    Peoria, Arizona 85381
    United States

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    Jonesboro, Arkansas 72401
    United States

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    Concord, California 94520
    United States

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    Long Beach, California 90807
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    Los Angeles, California 90057
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    Mission Hills, California 91345
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    Spring Valley, California 91978
    United States

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  • Novo Nordisk Investigational Site

    Tustin, California 92780
    United States

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  • Novo Nordisk Investigational Site

    Arvada, Colorado 80005
    United States

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  • Novo Nordisk Investigational Site

    Brooksville, Florida 34601
    United States

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  • Novo Nordisk Investigational Site

    Clearwater, Florida 33765
    United States

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  • Novo Nordisk Investigational Site

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    St. Petersburg, Florida 33709
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tampa, Florida 33603
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbus, Georgia 31904
    United States

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  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

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  • Novo Nordisk Clinical Trial Call Center

    Vestavia, Georgia 35209
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Meridien, Idaho 83642
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60611-5975
    United States

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  • Novo Nordisk Investigational Site

    Springfield, Illinois 62711
    United States

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  • Novo Nordisk Investigational Site

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40503
    United States

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  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

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  • Novo Nordisk Clinical Trial Call Center

    Baton Rouge, Louisiana 70808-4124
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbia, Maryland 21045
    United States

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  • Novo Nordisk Investigational Site

    Hyattsville, Maryland 20782
    United States

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  • Novo Nordisk Investigational Site

    Southfield, Michigan 48034-7661
    United States

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  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota 55416
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    St. Louis, Missouri 63110-1007
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Toms River, New Jersey 08755-8050
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albany, New York 12206
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Endwell, New York 13760
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hickory, North Carolina 28602
    United States

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  • Novo Nordisk Investigational Site

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio 45255
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dayton, Ohio 45439
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

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  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19107
    United States

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  • Novo Nordisk Investigational Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Moncks Corner, South Carolina 29461
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Mt. Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37411
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78728
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75231
    United States

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  • Novo Nordisk Investigational Site

    Round Rock, Texas 78681
    United States

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  • Novo Nordisk Investigational Site

    San Antonio, Texas 78207-5209
    United States

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  • Novo Nordisk Investigational Site

    Saint George, Utah 84790
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah 84102
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    St. George, Utah 84790
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Olympia, Washington 98502
    United States

    Site Not Available

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