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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01272219
First received: January 6, 2011
Last updated: March 5, 2015
Last verified: March 2015
  Purpose

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).


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 Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline in Fasting Body Weight [ Time Frame: Week 0, Week 56 ] [ Designated as safety issue: No ]
    The observed mean change from baseline in fasting body weight (%) after 56 weeks of treatment (main treatment period).

  • Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. [ Time Frame: At Week 56 ] [ Designated as safety issue: No ]
    Proportion of subjects losing at least 5% of baseline fasting body weight in 56 weeks of treatment (main treatment period).

  • Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight. [ Time Frame: At 56 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects losing more than 10% of baseline fasting body weight in 56 weeks of treatment (main treatment period).

  • Proportion of Subjects With Onset of Type 2 Diabetes [ Time Frame: at 160 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Waist Circumference (cm). [ Time Frame: Week 0, Week 56 ] [ Designated as safety issue: No ]
    The observed mean change from baseline in waist circumference (cm) after 56 weeks of treatment (main treatment period).

  • Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline) [ Time Frame: Week 0, week 160 ] [ Designated as safety issue: No ]
  • Pre-diabetes Status After 56 Weeks of Treatment. [ Time Frame: Week 0, Week 56 ] [ Designated as safety issue: No ]
    Proportion of subject with no pre-diabetes and with pre-diabetes/diabetes after 56 weeks of treatment.

  • Change From Baseline in Pre-diabetes Status (Subjects With Pre-diabetes at Baseline) [ Time Frame: Week 0, week 160 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Body Weight (Subjects With Pre-diabetes at Baseline) [ Time Frame: Week 0, week 160 ] [ Designated as safety issue: No ]
  • Proportion of Subjects Losing at Least 5% and More Than 10% of Baseline Body Weight (Subjects With Pre-diabetes at Baseline) [ Time Frame: at 160 weeks ] [ Designated as safety issue: No ]
  • Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes). [ Time Frame: Week 56, Week 68 ] [ Designated as safety issue: No ]
    The observed mean change in fasting body weight (%) from week 56 to week 68 of treatment, in re-randomised subjects with no pre-diabetes.

  • Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes). [ Time Frame: Week 0, Week 68 ] [ Designated as safety issue: No ]
    The observed mean change from baseline in fasting body weight (%) after 68 weeks of treatment, in re-randomised subjects with no pre-diabetes at baseline.


Enrollment: 3731
Study Start Date: June 2011
Study Completion Date: March 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68) Drug: liraglutide
Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).
Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68) Drug: placebo
Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68).
Placebo Comparator: Liraglutide Placebo, no Pre-diabetes Drug: placebo
Subject with no pre-diabetes at screening, receiving liraglutide placebo subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks, will continue to receive liraglutide placebo for 12 weeks (until week 68).
Experimental: Liraglutide 3.0mg, Pre-diabetes Drug: liraglutide
Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
Placebo Comparator: Liraglutide Placebo, Pre-diabetes Drug: placebo
Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 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
  • 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 of treated or untreated dyslipidemia and/or hypertension
  • Stable body weight (less than 5% selfreported change within the last 3 months)
  • Preceding failed dietary effort

Exclusion Criteria:

  • Known type 1 or type 2 diabetes
  • Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose 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 familial medullary 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/or diastolic blood pressure of 100 mmHg or above)
  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: NCT01272219

  Show 90 Study Locations
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: NCT01272219     History of Changes
Other Study ID Numbers: NN8022-1839, 2008-001049-24, U1111-1118-7871
Study First Received: January 6, 2011
Results First Received: January 22, 2015
Last Updated: March 5, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Austrian Federal Office for Safety in Health Care
Switzerland: Swissmedic
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicines and Healthcare Products
Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Brazil: National Health Surveillance Agency
Hong Kong: Department of Health
India: Ministry of Health
Israel: Ministry of Health
Mexico: National Commission for the Prevention of Sanitary Risks
Russia: Federal Service for Control of Health Care and Social Development
South Africa: Medicines Control Council
Turkey: Ministry of Health
Hungary: National Institute of Pharmacy
Serbia: Medicines and Medical Devices Agency of Serbia
Poland: The Office for Reg. of Medicinal Products, Medical Devices and Biocidal Products - Central Register of Clinical Trials
United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on April 26, 2015