Liraglutide, in combination with a reduced-calorie diet and increased physical activity, delayed the onset of type 2 diabetes in obese patients with prediabetes, according to new data.
The study results also showed that the drug led to significant, sustained weight loss over 3 years.
“The 3-year data show that liraglutide 3.0 mg can provide sustained weight loss and delay the time to onset of type 2 diabetes. These results are very important since we know that many people with obesity, if left untreated, will eventually develop type 2 diabetes,” said clinical trial investigator Carel le Roux, MBChB, MSC, FRCP, FRCPath, PhD, of the University College Dublin in Ireland.
Dr le Roux presented the phase 3a SCALE (Satiety and Clinical Adiposity: Liraglutide Evidence in Non-Diabetic and Diabetic adults) Obesity and Prediabetes 3-year trial extension data at ObesityWeek 2015.
The researchers noted that the extension study met its primary end point by demonstrating that liraglutide postponed onset of type 2 diabetes.
Specifically, results showed that over 160 weeks, the time to onset of type 2 diabetes was 2.7 times longer for patients in the liraglutide group vs the placebo group (95% CI, 1.9-3.9). Furthermore, risk for developing type 2 diabetes was reduced by 79.3% among those taking liraglutide vs placebo (P<.0001).
At week 160, the 1505 patients randomly assigned to treatment with liraglutide achieved an average body weight loss of 6.1% from baseline, as compared with 1.9% for the 749 patients in the placebo arm (estimated treatment difference, 4.3%; P<.0001), the researchers found.
The study also showed that 49.6% of adults treated with liraglutide lost at least 5% of their body weight compared with 23.7% of adults on placebo (P<.0001). In addition, 24.8% lost more than 10% of their body weight when treated with liraglutide compared with 9.9% of those treated with placebo (P<.0001).
The researchers also noted that more adults treated with liraglutide vs placebo completed the 160-week extension trial (52.6% vs 45%).
“A key take-away from this trial is that treating obesity is not just about weight loss; it’s also about health gain. In fact, an important finding from this trial was that patients with obesity and prediabetes who were treated with liraglutide 3.0 mg were almost 80% less likely to go onto develop type 2 diabetes,” Dr le Roux told Endocrinology Advisor.
Withdrawal rates due to adverse events were 13.3% with liraglutide compared with 6.2% with placebo. Serious adverse events were reported by 15.1% in the liraglutide group vs 12.9% with placebo.
Although incidence was low, gallbladder-related events were more frequent with liraglutide than placebo (2.9 vs 1.2 per 100 patient-years of observation). The incidence of cases of confirmed pancreatitis was also low in both the liraglutide and placebo arms (0.29 and 0.13 events per 100 patient-years of observation).
This agent is a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist with 97% similarity to naturally occurring human GLP-1. It regulates appetite and lowers body weight through decreased food intake.
Liraglutide was approved by the FDA on December 23, 2014, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or those who are overweight and have at least 1 weight-related comorbid condition.
SCALE Obesity and Prediabetes is a multinational trial in adults without diabetes with obesity and adults without diabetes who are overweight with weight-related comorbidities. There were 3731 individuals randomly assigned to treatment with liraglutide or placebo in combination with reduced-calorie diet and increased physical activity. In addition, individuals were further stratified to 56 weeks or 160 weeks of treatment based on prediabetes status at baseline screening.
Disclosure: This study was sponsored by Novo Nordisk.
- Le Roux C, Astrup A, Fujioka K, et al. T-P-LB-3843. Reduction in the risk of developing type 2 diabetes (T2D) with liraglutide 3.0 mg in people with prediabetes from the SCALE Obesity and Prediabetes randomized, double-blind, placebo-controlled trial. Presented at ObesityWeek; November 2-6, 2015; Los Angeles, CA.