In a new international clinical trial, it was shown that the drug liraglutide 3.0 mg may reduce diabetes risk by 80% in individuals with obesity and prediabetes.
Prediabetes, also commonly referred to as borderline diabetes, is a metabolic condition and growing global problem that is closely tied to obesity. If undiagnosed or untreated, prediabetes can develop into type 2 diabetes; which, whilst treatable, is currently not fully reversible.
At this point in time (March 1, 2017), the FDA has not approved any drugs to treat prediabetes, except to improve nutrition and increase physical activity, even though a number of drugs have been shown in studies to reduce the risk of prediabetes becoming diabetes.
The study ran between June 1, 2011, and March 2, 2015. They randomly assigned 2,254 patients to receive liraglutide (n=1505) or placebo (n=749). 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 the 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 (95% CI 1·9 to 3·9, p<0·0001). 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.
An international new clinical trial conducted by the University of Liverpool showed that according to a study published in The Lancet journal. This three-year SCALE obesity and prediabetes trial followed 2,254 adults with prediabetes at 191 research sites in 27 countries worldwide. The aim was to evaluate whether liraglutide 3.0 mg can safely delay the onset of type 2 diabetes in participants with prediabetes.
Liraglutide promotes weight loss by interacting with the areas of the brain that control appetite and energy intake.
The participants in the study were randomly allocated to either liraglutide 3.0 mg or a placebo delivered by injection under the skin once daily for 160 weeks. They were also placed on a reduced-calorie diet and advised to increase their physical activity.
The study showed that three years of continuous treatment with once-daily liraglutide 3.0 mg, in combination with diet and increased physical activity, reduces the risk of developing type 2 diabetes by 80% and results in greater sustained weight loss compared to the placebo. Professor John Wilding, Professor of Medicine at the University’s Institute of Ageing and Chronic Disease and Honorary Consultant Physician, is an obesity specialist, was an investigator in the trial and is an author of this study.
Professor Wilding said: “In this study, we wanted to see if this drug, in combination with a reduced-calorie diet and lifestyle intervention, could delay the onset of type 2 diabetes in a high-risk population with obesity and prediabetes….On the basis of our findings, liraglutide 3.0 mg can provide us with a new therapeutic approach for patients with obesity and prediabetes to substantially reduce their risk of developing type 2 diabetes and its related complications.
“As healthcare professionals, it is important that we can offer a treatment to our type 2 diabetes patients that we are confident will achieve results in the real world that are consistent with the results of the clinical trial program.”
In conclusion, Liraglutide 3.0 mg was shown to reduce body weight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE program.
The study is entitled 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: A randomized, double–blind trial.
- Treatment with the drug liraglutide versus placebo reduced the risk of going from prediabetes to diabetes by 80%.
- Liraglutide, when used alone, does not increase the risk for hypoglycemia.
- Liraglutide can reduce blood pressure, weight, and A1c, and can prevent diabetes for those at greatest risk.
The full study, entitled ‘3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial’, can be found here http://dx.doi.org/10.1016/S0140-6736(17)30069-7.