NCT01272232

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 846 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metabolism and Nutrition Disorder
• Obesity

Interventions

Type	Name	Description
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.
DRUG	placebo	Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-01-01
• Completion: 2013-01-25
• First posted: 2011-01-07
• Last updated: 2017-12-29
• Results posted: 2015-02-09

Locations

161 sites across 13 countries: United States, France, Germany, India, Israel, Italy, Puerto Rico, South Africa, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom