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

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

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).

It had three arms (groups): one (experimental), one (experimental) and Placebo (experimental).

The registry classes the interventions as drug.

Who Took Part

846 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Body Mass Index (BMI) at least 27.0 kg/m\^2. Stable body weight. Preceding failed dietary effort.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2011-06-01 with completion listed for 2013-01-01.

It ran at 161 sites in United States (67), United Kingdom (17), Germany (13), Italy (9), South Africa (9) and Sweden (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change (%) From Baseline in Body Weight (Fasting) (time frame: Week 0, week 56).

It also tracked 9 secondary outcomes, for example Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c), Change From Baseline in Waist Circumference, Change (%) From Baseline in Body Weight (Fasting), Change (%) From Week 56 to 68 in Body Weight (Fasting), Change From Baseline in Waist Circumference and Change From Week 56 to 68 in Waist Circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 846 people.

With 846 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.