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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01272232
First received: January 6, 2011
Last updated: February 28, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects losing at least 5% of baseline body weight [ Time Frame: at 56 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects losing more than 10% of baseline body weight [ Time Frame: at 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change (%-points) from baseline in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Proportion of subjects reaching target HbA1c below 7% [ Time Frame: at 56 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects reaching target HbA1c below or equal to 6.5% [ Time Frame: at 56 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in waist circumference [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change (%) from baseline in body weight (fasting) [ Time Frame: Week 0, week 68 ] [ Designated as safety issue: No ]
  • Change (%) from week 56 to 68 in body weight (fasting) [ Time Frame: Week 56, week 68 ] [ Designated as safety issue: No ]
  • Change from baseline in waist circumference [ Time Frame: Week 0, week 68 ] [ Designated as safety issue: No ]
  • Change from week 56 to 68 in waist circumference [ Time Frame: Week 56, week 68 ] [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Time Frame: Weeks 0-56 ] [ Designated as safety issue: No ]

Enrollment: 846
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: January 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272232

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Vestavia, Alabama, United States, 35209
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Peoria, Arizona, United States, 85381
United States, Arkansas
Novo Nordisk Clinical Trial Call Center
Jonesboro, Arkansas, United States, 72401
United States, California
Novo Nordisk Clinical Trial Call Center
Concord, California, United States, 94520
Novo Nordisk Clinical Trial Call Center
Long Beach, California, United States, 90807
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90057
Novo Nordisk Clinical Trial Call Center
Mission Hills, California, United States, 91345
Novo Nordisk Clinical Trial Call Center
Spring Valley, California, United States, 91978
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Arvada, Colorado, United States, 80005
United States, Florida
Novo Nordisk Clinical Trial Call Center
Brooksville, Florida, United States, 34601
Novo Nordisk Clinical Trial Call Center
Clearwater, Florida, United States, 33765
Novo Nordisk Clinical Trial Call Center
Hollywood, Florida, United States, 33021
Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida, United States, 34741
Novo Nordisk Clinical Trial Call Center
Plantation, Florida, United States, 33324
Novo Nordisk Clinical Trial Call Center
Tampa, Florida, United States, 33603
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30318
Novo Nordisk Clinical Trial Call Center
Columbus, Georgia, United States, 31904
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076
United States, Hawaii
Novo Nordisk Clinical Trial Call Center
Honolulu, Hawaii, United States, 96813
United States, Idaho
Novo Nordisk Clinical Trial Call Center
Meridien, Idaho, United States, 83642
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60611-5975
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60607
Novo Nordisk Clinical Trial Call Center
Springfield, Illinois, United States, 62704
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Topeka, Kansas, United States, 66606
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, United States, 40213
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Columbia, Maryland, United States, 21045
Novo Nordisk Clinical Trial Call Center
Hyattsville, Maryland, United States, 20782
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Southfield, Michigan, United States, 48034-7661
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Minneapolis, Minnesota, United States, 55416-2699
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Saint Louis, Missouri, United States, 63110-1007
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Clinical Trial Call Center
Albany, New York, United States, 12206
Novo Nordisk Clinical Trial Call Center
Endwell, New York, United States, 13760
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Asheville, North Carolina, United States, 28803
Novo Nordisk Clinical Trial Call Center
Greensboro, North Carolina, United States, 27408
Novo Nordisk Clinical Trial Call Center
Hickory, North Carolina, United States, 28602
Novo Nordisk Clinical Trial Call Center
Morehead City, North Carolina, United States, 28557
Novo Nordisk Clinical Trial Call Center
Raleigh, North Carolina, United States, 27609
Novo Nordisk Clinical Trial Call Center
Salisbury, North Carolina, United States, 28144
Novo Nordisk Clinical Trial Call Center
Wilmington, North Carolina, United States, 28401
Novo Nordisk Clinical Trial Call Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45255
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45439
United States, Oklahoma
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Anderson, South Carolina, United States, 29621
Novo Nordisk Clinical Trial Call Center
Moncks Corner, South Carolina, United States, 29461
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Bristol, Tennessee, United States, 37620
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37411
United States, Texas
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78728
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78731
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75231
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78207-5209
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78258
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78240
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84102
Novo Nordisk Clinical Trial Call Center
St. George, Utah, United States, 84790
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23502
United States, Washington
Novo Nordisk Clinical Trial Call Center
Olympia, Washington, United States, 98502
France
Bondy, France, 93143
Germany
Münster, Germany, 48145
Israel
Haifa, Israel, 35152
Puerto Rico
Novo Nordisk Clinical Trial Call Center
San Juan, Puerto Rico, 00921
South Africa
Pretoria, Gauteng, South Africa, 0001
Spain
Granada, Spain, 18012
Sweden
Göteborg, Sweden, 417 17
Turkey
Hatay, Turkey, 31040
United Kingdom
Cambridge, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272232     History of Changes
Other Study ID Numbers: NN8022-1922, 2008-002199-88, U1111-1118-7963
Study First Received: January 6, 2011
Last Updated: February 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Israeli Health Ministry Pharmaceutical Administration
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Overweight
Body Weight
Nutrition Disorders
Malnutrition
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 19, 2014