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

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).


Study Type: Interventional
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
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:
- Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
- Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
  Placebo Comparator: Liraglutide Placebo, no Pre-diabetes
- Experimental: Liraglutide 3.0mg, Pre-diabetes
- Placebo Comparator: Liraglutide Placebo, Pre-diabetes


Related journal: A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management