Results determined for 3-year study of liraglutide versus placebo diabetes risk reduction and weight management in individuals with prediabetes.
With over 90 million people with prediabetes, it is important to understand the best options to prevent or delay the diagnosis of type 2 diabetes. In this study, they randomized 2,254 patients in a 2:1 ratio using a telephone or web-based system to receive either once-daily subcutaneous liraglutide (3.0 mg) or a matched placebo as an adjunct to a reduced-calorie diet and increased physical activity over 160 weeks. Individuals in the study were age 18 years or older and had prediabetes and a body mass index of at least 30 kg/m2 or at least 27 kg/m2 with comorbidities. All participants received standardized lifestyle intervention counseling approximately once a month throughout the trial. The trial was conducted at 191 clinical research sites in 27 countries and is registered with ClinicalTrials.gov, number NCT01272219.
The study ran between June 1, 2011, and March 2, 2015. 1,128 (50%) participants completed the study up to week 160, after withdrawal of 714 (47%) participants in the liraglutide group and 412 (55%) participants in the placebo group. By week 160, 26 (2%) of 1,472 individuals in the liraglutide group versus 46 (6%) of 738 in the placebo group were diagnosed with diabetes while on treatment. The mean time from randomization to diagnosis was 99 (SD 47) weeks for the 26 individuals in the liraglutide group versus 87 (47) weeks for the 46 individuals in 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 2·7 times longer with liraglutide than with placebo (p<0·0001), corresponding with a hazard ratio of 0·21. Liraglutide induced greater weight loss than placebo at week 160 (–6·1 [SD 7·3] vs −1·9% [6·3]; estimated treatment difference −4·3%, 95% CI −4·9 to −3·7, p<0·0001). Serious adverse events were reported by 227 (15%) of 1,501 randomized-treated individuals in the liraglutide group versus 96 (13%) of 747 individuals in the placebo group.
Results showed that after 160 weeks, 2 percent of individuals in the liraglutide group were diagnosed with diabetes while on treatment compared with 6 percent in the placebo group. The mean time from randomization to diagnosis for participants in the liraglutide group was approximately 99 weeks compared with 87 weeks in the placebo group. The liraglutide group also showed greater weight loss and improvements in glycemic control and cardiometabolic risk factors than the placebo group.
Liraglutide 3·0 mg was shown to reduce bodyweight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE program. In the 3-year assessment of the SCALE Obesity and Prediabetes trial, they aimed to evaluate the proportion of individuals with prediabetes who were diagnosed with type 2 diabetes.
In this trial, 3 years of results were provided for this treatment, with the limitation that withdrawn individuals were not followed up after discontinuation. Liraglutide 3·0 mg might provide health benefits in terms of reduced risk of diabetes in individuals with obesity and prediabetes.
It was found that, “Liraglutide 3.0 mg, as a GLP-1 receptor agonist, provides a different treatment option for individuals with obesity or overweight, with or without type 2 diabetes, having direct glucose-dependent effects on insulin secretion and weight-loss mediated effects on improved insulin resistance,” the authors concluded.
In conclusion, it was found that liraglutide was associated with the lower risk of a diagnosis of type 2 diabetes in overweight or obese patients with prediabetes combined with diet and exercise along with sustained weight loss compared with placebo.
- Liraglutide was associated with the lower risk of a diagnosis of type 2 diabetes.
- It was also found that the use of liraglutide provided sustained weight loss in overweight or obese patients.
- Future studies will determine if liraglutide will be recommended for the prevention of type 2 diabetes.
Lancet Volume 389, No. 10077, p1399–1409, 8 April 2017