Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

Last updated: December 20, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes (Pediatric)

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT01272219
NN8022-1839
U1111-1118-7871
2008-001049-24
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.

The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.

Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent obtained

  • Body Mass Index (BMI) of 30.0 kg/m^2 or above

  • Body Mass Index (BMI) of 27 kg/m^2 or above in the presence of co-morbidities oftreated or untreated dyslipidemia and/or hypertension

  • Stable body weight

  • Preceding failed dietary effort

Exclusion

Exclusion Criteria:

  • Known type 1 or type 2 diabetes

  • Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasmaglucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)

  • Screening calcitonin of 50 ng/L or above

  • Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familialmedullary thyroid carcinoma (FMTC)

  • Personal history of non-familial medullary thyroid carcinoma

  • 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 of 160 mmHg or above and/ordiastolic blood pressure of 100 mmHg or above)

Study Design

Total Participants: 3731
Study Start date:
June 01, 2011
Estimated Completion Date:
March 02, 2015

Connect with a study center

  • Novo Nordisk Investigational Site

    Ciudad Autónoma de Bs As, C1426ABP
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Ciudad Autónoma de BsAs, C1406FWY
    Argentina

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    Ciudad de Buenos Aires, C1405CWB
    Argentina

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    Mar del Plata, B7600FZN
    Argentina

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    Camperdown, New South Wales 2050
    Australia

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    University Of Sydney, New South Wales 2006
    Australia

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    Woolloongabba, Queensland 4102
    Australia

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    Adelaide, South Australia 5005
    Australia

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    Heidelberg West, Victoria 3081
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    Graz, 8036
    Austria

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    Salzburg, 5020
    Austria

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    Wien, 1130
    Austria

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    Boussu, 7300
    Belgium

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    Edegem, 2650
    Belgium

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    Liège, 4000
    Belgium

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    Liège, 4000
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    Porto Alegre, Rio Grande Do Sul 90035-170
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    Edmonton, Alberta T6G 2E1
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    Mount Pearl, Newfoundland and Labrador A1N 1W7
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    Frederiksberg C, 1958
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    Hvidovre, 2650
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    Århus C, 8000
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    Helsinki, 00290
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    Kuopio, 07100
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    University Of Helsinki, 00014
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    Belgrade, 11000
    Former Serbia and Montenegro

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    Antibes, 06600
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    Lille, 59037
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    Nantes Cedex 1, 44093
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    PARIS cedex 13, 75651
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    Paris, 75877
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    Pierre-Bénite, 69495
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    Saint Herblain, 44800
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    Bad Nauheim, 61231
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    Beek, 6191JW
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    Hengelo OV, 7555 DL
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    St. Gallen, 9016
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    Coventry, CV2 2DX
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    Glasgow, G11 6NT
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    Hull, HU3 2RW
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    London, W6 8RF
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    Swansea, SA6 6NL
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    Birmingham, Alabama 35205-4731
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    Peoria, Arizona 85381-4253
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    Phoenix, Arizona 85027
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    Orange, California 92869
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    San Diego, California 92103-4140
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    Aurora, Colorado 80045
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    Colorado Springs, Colorado 80904
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    Denver, Colorado 80220-3706
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    Golden, Colorado 80401
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    Washington, District of Columbia 20036-5847
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    Baton Rouge, Louisiana 70808-4124
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    Kansas City, Missouri 64111
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    Saint Louis, Missouri 63141
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    Saint Peters, Missouri 63376
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    Rochester, New York 14609
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    Staten Island, New York 10301
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    Syracuse, New York 13210
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    Cary, North Carolina 27518
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    Raleigh, North Carolina 27612
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    Canal Fulton, Ohio 44614
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    Cincinnati, Ohio 45219
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    Franklin, Ohio 45005
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    Wadsworth, Ohio 44281-9236
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    Beaver, Pennsylvania 15009
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    Philadelphia, Pennsylvania 19107
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    West Reading, Pennsylvania 19611
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    Greer, South Carolina 29651
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    Austin, Texas 78731
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    Dallas, Texas 75251
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    Round Rock, Texas 78681
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    San Antonio, Texas 78229-4801
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    Salt Lake City, Utah 84107
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    Arlington, Virginia 22206
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    Henrico, Virginia 23233
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    Richmond, Virginia 23294
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    Virginia Beach, Virginia 23454
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    Renton, Washington 98057
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    Wenatchee, Washington 98801-2028
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    Milwaukee, Wisconsin 53209
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