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

December 6, 2017 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

846

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 12163
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 12203
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 12157
        • 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
        • Novo Nordisk Investigational Site
  • India
      • Pune, India, 411011
        • Novo Nordisk Investigational Site
      • Thriruvananthapuram, India, 695 032
        • Novo Nordisk Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302006
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Novo Nordisk Investigational Site
  • Israel
      • 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
        • Novo Nordisk Investigational Site
  • Italy
      • 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
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • Novo Nordisk Investigational Site
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Novo Nordisk Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novo Nordisk Investigational Site
    • Gauteng
      • 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
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk Investigational Site
    • North West
      • Brits, North West, South Africa, 0250
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7460
        • Novo Nordisk Investigational Site
      • Cape Town, Western Cape, South Africa, 7708
        • Novo Nordisk Investigational Site
  • Spain
      • Granada, Spain, 18012
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28034
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28007
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07010
        • Novo Nordisk Investigational Site
      • Partida De Bacarot, Spain, 03114
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41010
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41014
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41009
        • Novo Nordisk Investigational Site
  • Sweden
      • Dalby, Sweden, 240 10
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 417 17
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 416 65
        • Novo Nordisk Investigational Site
      • Luleå, Sweden, 972 33
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 141 86
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 112 81
        • Novo Nordisk Investigational Site
      • Ängelholm, Sweden, 262 81
        • Novo Nordisk Investigational Site
      • Örebro, Sweden, 701 85
        • Novo Nordisk Investigational Site
  • Taiwan
      • Taichung, Taiwan, 404
        • Novo Nordisk Investigational Site
      • Tainan city, Taiwan, 710
        • Novo Nordisk Investigational Site
      • Taoyuan, Taiwan, 333
        • Novo Nordisk Investigational Site
  • Turkey
      • 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
        • Novo Nordisk Investigational Site
  • United Kingdom
      • 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
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Vestavia Hills, Alabama, United States, 35209
        • Novo Nordisk Investigational Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Novo Nordisk Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Novo Nordisk Investigational Site
    • California
      • 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
        • Novo Nordisk Investigational Site
    • Colorado
      • Arvada, Colorado, United States, 80005
        • Novo Nordisk Investigational Site
    • Florida
      • 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
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Columbus, Georgia, United States, 31904
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novo Nordisk Investigational Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60611-5975
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Novo Nordisk Investigational Site
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Novo Nordisk Investigational Site
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
    • Michigan
      • Southfield, Michigan, United States, 48034-7661
        • Novo Nordisk Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Novo Nordisk Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Novo Nordisk Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
      • Toms River, New Jersey, United States, 08755-8050
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Novo Nordisk Investigational Site
      • Endwell, New York, United States, 13760
        • Novo Nordisk Investigational Site
    • North Carolina
      • 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
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Novo Nordisk Investigational Site
      • Moncks Corner, South Carolina, United States, 29461
        • Novo Nordisk Investigational Site
    • Tennessee
      • 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
        • Novo Nordisk Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • 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
      • San Antonio, Texas, United States, 78240
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78207-5209
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78258
        • Novo Nordisk Investigational Site
    • Utah
      • Saint George, Utah, United States, 84790
        • Novo Nordisk Investigational Site
      • Salt Lake City, Utah, United States, 84102
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Experimental: Lira 3.0 mg
Drug: liraglutide
Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Drug: liraglutide
Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Experimental: Lira 1.8 mg
Drug: liraglutide
Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Drug: liraglutide
Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0, week 56
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.
at 56 weeks
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.
at 56 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0, week 56
Proportion of Subjects Reaching Target HbA1c Below 7%
Time Frame: at 56 weeks
at 56 weeks
Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%
Time Frame: at 56 weeks
at 56 weeks
Change From Baseline in Waist Circumference
Time Frame: Week 0, week 56
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.
Week 0, week 68
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.
Week 56, week 68
Change From Baseline in Waist Circumference
Time Frame: Week 0, week 68
Week 0, week 68
Change From Week 56 to 68 in Waist Circumference
Time Frame: Week 56, week 68
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]).
Weeks 0-56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 25, 2013

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Actual)

December 29, 2017

Last Update Submitted That Met QC Criteria

December 6, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8022-1922
  • 2008-002199-88 (EudraCT Number)
  • U1111-1118-7963 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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