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SCALE results

Liraglutide adds non-diabetic overweight and obese

66 percent of participants taking liraglutide no longer had prediabetes and returned to normoglycemia, compared with 36 percent of those on placebo

For people with prediabetes who are overweight or obese, adding 3.0mg of liraglutide for three years to a diet and exercise plan may lead to major health improvements, according to outcomes from the SCALE (Satiety and Clinical Adiposity - Liraglutide Evidence) trial, in a presentation, ‘OR36-1 Liraglutide 3.0 Mg Reduces Body Weight and Improves Cardiometabolic Risk Factors in Adults with Obesity or Overweight and Prediabetes: The Scale Obesity and Prediabetes Randomized, Double-Blind, Placebo-Controlled 3-Year Trial’, presented at ENDO 2016, the annual meeting of the Endocrine Society, in Boston.

"Treatment with subcutaneous liraglutide 3.0mg for three years, combined with a reduced-calorie diet and increased physical activity, can help people to not only lose weight, but also reduce the risk of Type 2 diabetes and improve cardiometabolic risk factors, which may ultimately reduce the risk of cardiovascular disease - the number one cause of death globally," said lead study author, Dr Ken Fujioka, director of nutrition and metabolic research, and director for weight management at Scripps Research Institute in La Jolla, California.

Over a three-year period, the researchers studied 2,254 overweight and obese adults whose average age was around 48 years and who also had either high cholesterol or high blood pressure, or both. The authors randomly assigned 1,505 participants to treatment with liraglutide 3.0mg and 749 participants to treatment with placebo. All patients were put on a 500-calorie-per-day diet and a 150-minute-per-week physical activity program, and they were given counselling.

After three years, those taking liraglutide lost weight and lowered their risk of Type 2 diabetes. Overall, 66 percent of participants taking liraglutide no longer had prediabetes and returned to normoglycemia, compared with 36 percent of those on placebo.

The liraglutide group's blood glucose levels dropped to normal, their waist circumference was smaller and their cardiometabolic risk factors, including systolic blood pressure and some fasting lipids and cardiovascular biomarkers, decreased.

Side effects and serious event rates were similar in both groups. Major adverse cardiovascular events were generally low, and no new safety issues were found. Of the four people who died, two were on liraglutide and two were on placebo.

In conclusion, in individuals with prediabetes, three years of treatment with liraglutide 3.0mg, as an adjunct to diet and exercise, was associated with delayed onset and reduced risk of T2DM, weight loss and improvements in cardiometabolic risk factors, which if sustained in the long term may be associated with reduced CV risk. No new safety issues were identified.

"Type 2 diabetes is a major cause of death in the US. Both obesity, a chronic disease with serious health consequences, and prediabetes, typically defined as blood glucose concentrations that are higher than normal but lower than diabetes thresholds, increase the risk of developing Type 2 diabetes," added Fujioka. "For people with overweight or obesity and prediabetes, losing between 5 and 10 percent of their body weight can reduce their risk of Type 2 diabetes and other obesity-related health consequences."

Novo Nordisk A/S, Denmark, funded the study.

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