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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272232
First Posted: January 7, 2011
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose

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.


Condition Intervention Phase
Metabolism and Nutrition Disorder Obesity Drug: liraglutide Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change (%) From Baseline in Body Weight (Fasting) [ Time Frame: Week 0, week 56 ]
    Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.

  • Proportion of Subjects Losing at Least 5% of Baseline Body Weight [ Time Frame: at 56 weeks ]
    Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.

  • Proportion of Subjects Losing More Than 10% of Baseline Body Weight [ Time Frame: at 56 weeks ]
    Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.


Secondary Outcome Measures:
  • Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: Week 0, week 56 ]
    Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.

  • Proportion of Subjects Reaching Target HbA1c Below 7% [ Time Frame: at 56 weeks ]
  • Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5% [ Time Frame: at 56 weeks ]
  • Change From Baseline in Waist Circumference [ Time Frame: Week 0, week 56 ]
  • Change (%) From Baseline in Body Weight (Fasting) [ Time Frame: Week 0, week 68 ]
    Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.

  • Change (%) From Week 56 to 68 in Body Weight (Fasting) [ Time Frame: Week 56, week 68 ]
    Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.

  • Change From Baseline in Waist Circumference [ Time Frame: Week 0, week 68 ]
  • Change From Week 56 to 68 in Waist Circumference [ Time Frame: Week 56, week 68 ]
  • Incidence of Hypoglycaemic Episodes [ Time Frame: Weeks 0-56 ]
    Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL]).


Enrollment: 846
Actual Study Start Date: June 1, 2011
Study Completion Date: January 25, 2013
Primary Completion Date: January 1, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lira 3.0 mg Drug: liraglutide
Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Experimental: Lira 1.8 mg Drug: liraglutide
Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Experimental: Placebo Drug: placebo
Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272232


  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, United States, 35209
United States, Arizona
Novo Nordisk Investigational Site
Peoria, Arizona, United States, 85381
United States, Arkansas
Novo Nordisk Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
Novo Nordisk Investigational Site
Concord, California, United States, 94520
Novo Nordisk Investigational Site
Long Beach, California, United States, 90807
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
Mission Hills, California, United States, 91345
Novo Nordisk Investigational Site
Spring Valley, California, United States, 91978
Novo Nordisk Investigational Site
Tustin, California, United States, 92780
United States, Colorado
Novo Nordisk Investigational Site
Arvada, Colorado, United States, 80005
United States, Florida
Novo Nordisk Investigational Site
Brooksville, Florida, United States, 34601
Novo Nordisk Investigational Site
Clearwater, Florida, United States, 33765
Novo Nordisk Investigational Site
Hollywood, Florida, United States, 33021
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
Novo Nordisk Investigational Site
Plantation, Florida, United States, 33324
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33603
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site
Columbus, Georgia, United States, 31904
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Idaho
Novo Nordisk Investigational Site
Meridian, Idaho, United States, 83642
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60611-5975
Novo Nordisk Investigational Site
Springfield, Illinois, United States, 62711
United States, Kansas
Novo Nordisk Investigational Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
Novo Nordisk Investigational Site
Louisville, Kentucky, United States, 40213
United States, Louisiana
Novo Nordisk Investigational Site
New Orleans, Louisiana, United States, 70121
United States, Maryland
Novo Nordisk Investigational Site
Columbia, Maryland, United States, 21045
Novo Nordisk Investigational Site
Hyattsville, Maryland, United States, 20782
United States, Michigan
Novo Nordisk Investigational Site
Southfield, Michigan, United States, 48034-7661
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55416
United States, Missouri
Novo Nordisk Investigational Site
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
Novo Nordisk Investigational Site
Endwell, New York, United States, 13760
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28803
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States, 27408
Novo Nordisk Investigational Site
Hickory, North Carolina, United States, 28602
Novo Nordisk Investigational Site
Morehead City, North Carolina, United States, 28557
Novo Nordisk Investigational Site
Raleigh, North Carolina, United States, 27609
Novo Nordisk Investigational Site
Salisbury, North Carolina, United States, 28144
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States, 28401
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45255
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45439
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Novo Nordisk Investigational Site
Anderson, South Carolina, United States, 29621
Novo Nordisk Investigational Site
Moncks Corner, South Carolina, United States, 29461
United States, Tennessee
Novo Nordisk Investigational Site
Bristol, Tennessee, United States, 37620
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37212
United States, Texas
Novo Nordisk Investigational Site
Austin, Texas, United States, 78728
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Round Rock, Texas, United States, 78681
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78207-5209
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78240
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78258
United States, Utah
Novo Nordisk Investigational Site
Saint George, Utah, United States, 84790
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84102
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
United States, Washington
Novo Nordisk Investigational Site
Olympia, Washington, United States, 98502
France
Novo Nordisk Investigational Site
Bondy, France, 93143
Novo Nordisk Investigational Site
LA ROCHELLE cedex, France, 17019
Novo Nordisk Investigational Site
Le Creusot, France, 71200
Novo Nordisk Investigational Site
Nanterre, France, 92014
Novo Nordisk Investigational Site
Narbonne, France, 11108
Novo Nordisk Investigational Site
Pointe à Pitre, France, 97139
Novo Nordisk Investigational Site
Saint Herblain, France, 44800
Novo Nordisk Investigational Site
Venissieux, France, 69200
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 12157
Novo Nordisk Investigational Site
Berlin, Germany, 12163
Novo Nordisk Investigational Site
Berlin, Germany, 12203
Novo Nordisk Investigational Site
Dresden, Germany, 01307
Novo Nordisk Investigational Site
Dresden, Germany, 01309
Novo Nordisk Investigational Site
Gebhardshain, Germany, 57580
Novo Nordisk Investigational Site
Hamburg, Germany, 22607
Novo Nordisk Investigational Site
Heidelberg, Germany, 69120
Novo Nordisk Investigational Site
Hohenmölsen, Germany, 06679
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Schkeuditz, Germany, 04435
Novo Nordisk Investigational Site
Stuttgart, Germany, 70378
Novo Nordisk Investigational Site
Wangen, Germany, 88239
India
Novo Nordisk Investigational Site
Jaipur, Rajasthan, India, 302006
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600086
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700020
Novo Nordisk Investigational Site
Pune, India, 411011
Novo Nordisk Investigational Site
Thriruvananthapuram, India, 695 032
Israel
Novo Nordisk Investigational Site
Beer Sheva, Israel, 84101
Novo Nordisk Investigational Site
Haifa, Israel, 31096
Novo Nordisk Investigational Site
Haifa, Israel, 35152
Novo Nordisk Investigational Site
Jerusalem, Israel, 91120
Novo Nordisk Investigational Site
Rishon Le Zion, Israel, 75650
Novo Nordisk Investigational Site
Tel Hashomer, Israel, 52621
Italy
Novo Nordisk Investigational Site
Catanzaro, Italy, 88100
Novo Nordisk Investigational Site
Chieti Scalo, Italy, 66100
Novo Nordisk Investigational Site
Firenze, Italy, 50141
Novo Nordisk Investigational Site
Forlì, Italy, 47100
Novo Nordisk Investigational Site
Latina, Italy, 04100
Novo Nordisk Investigational Site
Milano, Italy, 20132
Novo Nordisk Investigational Site
Padova, Italy, 35143
Novo Nordisk Investigational Site
Perugia, Italy, 06126
Novo Nordisk Investigational Site
Pistoia, Italy, 51100
Puerto Rico
Novo Nordisk Investigational Site
San Juan, Puerto Rico, 00921
South Africa
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6045
Novo Nordisk Investigational Site
Bloemfontein, Free State, South Africa, 9301
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2194
Novo Nordisk Investigational Site
Lenasia, Gauteng, South Africa, 1827
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa, 0001
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site
Brits, North West, South Africa, 0250
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7460
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7708
Spain
Novo Nordisk Investigational Site
Granada, Spain, 18012
Novo Nordisk Investigational Site
Madrid, Spain, 28007
Novo Nordisk Investigational Site
Madrid, Spain, 28034
Novo Nordisk Investigational Site
Palma de Mallorca, Spain, 07010
Novo Nordisk Investigational Site
Partida de Bacarot, Spain, 03114
Novo Nordisk Investigational Site
Sevilla, Spain, 41009
Novo Nordisk Investigational Site
Sevilla, Spain, 41010
Novo Nordisk Investigational Site
Sevilla, Spain, 41014
Sweden
Novo Nordisk Investigational Site
Dalby, Sweden, 240 10
Novo Nordisk Investigational Site
Göteborg, Sweden, 416 65
Novo Nordisk Investigational Site
Göteborg, Sweden, 417 17
Novo Nordisk Investigational Site
Luleå, Sweden, 972 33
Novo Nordisk Investigational Site
Lund, Sweden, 221 85
Novo Nordisk Investigational Site
Stockholm, Sweden, 112 81
Novo Nordisk Investigational Site
Stockholm, Sweden, 141 86
Novo Nordisk Investigational Site
Ängelholm, Sweden, 262 81
Novo Nordisk Investigational Site
Örebro, Sweden, 701 85
Taiwan
Novo Nordisk Investigational Site
Taichung, Taiwan, 404
Novo Nordisk Investigational Site
Tainan city, Taiwan, 710
Novo Nordisk Investigational Site
Taoyuan, Taiwan, 333
Turkey
Novo Nordisk Investigational Site
Ankara, Turkey, 06100
Novo Nordisk Investigational Site
Gaziantep, Turkey, 27070
Novo Nordisk Investigational Site
Hatay, Turkey, 31040
Novo Nordisk Investigational Site
Istanbul, Turkey, 34096
Novo Nordisk Investigational Site
Izmir, Turkey, 35340
Novo Nordisk Investigational Site
Kahramanmaras, Turkey, 46000
United Kingdom
Novo Nordisk Investigational Site
Airdrie, United Kingdom, ML6 0JS
Novo Nordisk Investigational Site
Ayr, United Kingdom, KA6 6DX
Novo Nordisk Investigational Site
Bexhill-on-Sea, United Kingdom, TN39 4SP
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B9 5SS
Novo Nordisk Investigational Site
Bristol, United Kingdom, BS10 5NB
Novo Nordisk Investigational Site
Cambridge, United Kingdom, CB2 2QQ
Novo Nordisk Investigational Site
Chester, United Kingdom, CH2 1UL
Novo Nordisk Investigational Site
Darlington, United Kingdom, DL2 1AA
Novo Nordisk Investigational Site
Leeds, United Kingdom, LS25 1AN
Novo Nordisk Investigational Site
Leicester, United Kingdom, LE5 4PW
Novo Nordisk Investigational Site
London, United Kingdom, E1 2EF
Novo Nordisk Investigational Site
Middlesbrough, United Kingdom, TS4 3BW
Novo Nordisk Investigational Site
Nottingham, United Kingdom, NG7 2UH
Novo Nordisk Investigational Site
Plymouth, United Kingdom, PL6 8BQ
Novo Nordisk Investigational Site
Rotherham, United Kingdom, S651DA
Novo Nordisk Investigational Site
Swansea, United Kingdom, SA6 6NL
Novo Nordisk Investigational Site
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272232     History of Changes
Other Study ID Numbers: NN8022-1922
2008-002199-88 ( EudraCT Number )
U1111-1118-7963 ( Other Identifier: WHO )
First Submitted: January 6, 2011
First Posted: January 7, 2011
Results First Submitted: January 22, 2015
Results First Posted: February 9, 2015
Last Update Posted: November 1, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Overweight
Body Weight
Nutrition Disorders
Signs and Symptoms
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists