Saxenda® (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1,10 a hormone that is released in response to food intake.
Results from a post hoc analysis of the three-year part of the phase 3a SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence) Obesity and Prediabetes trial show that people treated with Saxenda® (liraglutide 3 mg) experienced consistent weight loss and improved blood glucose control across baseline body mass index (BMI) categories over three years as compared to placebo treatment.
These data were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016. In the trial, adults with prediabetes and obesity or who were overweight with comorbidities were randomised to receive Saxenda® (n=1,505) or placebo (n=749) for 160 weeks, both as an adjunct to a reduced-calorie diet and increased physical activity. “Treating obesity and related comorbidities can be complex and challenging,” said Professor Sten Madsbad, clinical professor at the University of Copenhagen and a SCALE clinical trial investigator.
“It is encouraging to now have three-year data demonstrating that, regardless of starting BMI, people in the trial experienced consistent weight loss and improvements in several measures of glycaemic control.” As part of this analysis, measures of blood glucose control and the overall safety profile across baseline BMI categories in people treated with Saxenda® vs placebo were assessed. These baseline BMI categories were classified as; overweight: BMI 27–29.9 kg/m2 , obesity class 1: BMI 30–34.9 kg/m2 , obesity class 2: BMI 35–39.9 kg/m2 and obesity class 3 and over: BMI ≥40 kg/m2 . People treated with Saxenda® experienced consistent weight loss across all BMI categories: 5.7%, BMI 27–29.9 kg/m2 ; 6.5%, BMI 30–34.9 kg/m2 ; 6.2%, BMI 35–39.9 kg/m2 ; 5.9%, BMI ≥40 kg/m2 compared to 1.8%, 1.7%, 1.8% and 2.1% in the same categories with placebo treatment. The percentage of individuals who reverted to normal blood glucose levels at 160 weeks on Saxenda® was also similar at: 67%, 67%, 70% and 63%, respectively, in each of the four BMI categories and significantly greater compared to 36%, 34%, 40% and 33%, respectively, with placebo (p<0.05).
In addition, consistent improvements were observed with Saxenda® treatment across BMI categories for several measures of blood glucose control, including HbA1c, fasting plasma glucose (FPG), fasting insulin, beta-cell function and insulin resistance.There were similar incidences of total and serious adverse events as well as gastrointestinal and hypoglycaemic events, across BMI categories. Saxenda® was generally well-tolerated, with observed side effects in line with previous trials.