The study points to an additional tool that could help prevent at-risk patients from progressing to diabetes.
Liraglutide, approved in different formulations to treat both type 2 diabetes (T2D) and obesity, helped most patients with prediabetes avoid disease progression when used with diet and exercise in a new study.
Carel le Roux, PhD, of Imperial College in London, published results in The Lancet based on a randomized controlled trial involving 2254 obese adults with prediabetes, who lived in 27 different countries. The trial compared health outcomes for 2 groups of adults; both were given diet and exercise regimen, with 1 group taking daily self-injections of liraglutide and the other given a placebo.
Patients in the study had either a body mass index (BMI) of 30 kg/m2, which meets CDC’s definition of obesity, or a BMI of 27 kg/m2 and at least 1 other comorbidity.
Those taking liraglutide took injections of 3 mg, which is the same dose that FDA approved for treatment of obesity. Novo Nordisk markets this formulation as Saxenda; smaller doses of 1.2 mg and 1.8 mg are marketed as Victoza to treat T2D. Last summer, results of the LEADER trial showed that lirgalutide could reduce the risk of cardiovascular death by 22%.
Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that regulates appetite. A major study in Cell Reports found that people who are obese often lack this hormone, and they overeat as a result.
The study ran from June 1, 2011, to March 2, 2015. Of the original participants 1128 (50%) completed the study for 160 weeks, with 714 (47%) of those in the liraglutide group withdrawing, and 412 (55%) of those in the placebo group withdrawing. By week 160, 26 (2%) of the patients in the liraglutide group were diagnosed with T2D, while 46 (6%) of those in the placebo group received this diagnosis. The mean time to diagnosis was 99 weeks for the liraglutide group and 87 weeks for the placebo group.
“Taking the different diagnosis frequencies between the treatment groups into account, the time to onset of diabetes over 160 weeks among all randomized individuals was 2 to 7 times longer with liraglutide than with placebo,” the study found.
After 3 years, the researchers found the patients given liraglutide were 80% less likely to develop diabetes than those taking placebo. In 60% of these patients, prediabetes was reversed.
An estimated 86 million people in the United States have prediabetes, and 9 in 10 do not know they have it, according to CDC. Medicare has taken steps to identify those with prediabetes and halt its progression, both to improve health and to avoid the escalating costs of the disease. Already, $1 of every $3 spent in Medicare goes to treat diabetes.
Medicare has agreed to fund the Diabetes Prevention Program (DPP) starting January 1, 2018, and is still working on how it will pay for various formats. Studies of the DPP show it reduces progression to diabetes for 58% of the participants.
According to the authors, liraglutide could provide a complement to these efforts for patients who are already overweight or obese.
“These groundbreaking results could pave the way for a widely used, effective, and safe drug to reverse prediabetes and prevent diabetes in 80% of at-risk people,” le Roux said in a statement. “This could improve the health of the population and save millions on healthcare spending.”
Le Roux, CW, Astrop A, Fujioka K, et al. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial [published on line February 23, 2017]. The Lancet, 2017; DOI: 10.1016/S0140-6736(17)30069-7