An international clinical trial conducted by the University of Liverpool has shown that the drug liraglutide 3.0 mg may reduce diabetes risk by 80% in individuals with obesity and prediabetes according to a study published today in The Lancet.
This three-year SCALE obesity and prediabetes trial followed 2254 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.
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.
Significant health cost
In the UK 1 in 10 of the population have prediabetes. The associated health care cost to the economy is significant. These individuals are at risk of a range of conditions that can affect their overall health including type 2 diabetes and its complications as well as cardiovascular disease and cancer.
Liraglutide promotes weight loss by interacting with the areas of the brain that control appetite and energy intake.
The participants in the study, which was conducted at University Hospital Aintree, 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.
New therapeutic approach
Professor John Wilding, Professor of Medicine at the University of Liverpool and Honorary Consultant Physician is an obesity specialist was an investigator in the trial and 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 programme."
The study is a continuation of work started by Professor Wilding in 1996 when he was working at the Hammersmith Hospital in London, and was part of the team that first showed that the hormone GLP-1, on which liraglutide is based, was involved in the control of food intake. Professor Wilding adds "It is very exciting to see a laboratory observation translated into a medicine that has the potential to help so many people, even though it has taken over 20 years."
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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 once the embargo has lifted.
Editors Notes
According to http://www.diabetes.org.uk there are 2.8 million people in the UK with type 2 diabetes. There are about 5 million at high risk (prediabetes); about 200000 of these will develop diabetes each year.
For information about the NHS National Diabetes Prevention Programme please visit https://www.england.nhs.uk/ourwork/qual-clin-lead/diabetes-prevention/
Professor John Wilding Biography
John Wilding leads Clinical Research into Obesity, Diabetes and Endocrinology at the University of Liverpool, UK. He trained in medicine in Southampton and at the Hammersmith Hospital, London where he also undertook three years laboratory-based research into the neurobiology of obesity and diabetes. He has worked at University Hospital Aintree, Liverpool since 1996 and as Professor of Medicine since 2005. He leads specialist services for severe obesity at University Hospital Aintree - designated a Centre for Obesity Management by the European Association for the Study of Obesity. He is a Council member of the Royal College of Physicians and chairs the UK National Clinical Research Network Metabolic and Endocrine Speciality Group. He has published over 250 research papers, chapters and review articles related to his clinical and laboratory research interests in the pathophysiology of obesity and type 2 diabetes and evaluation of new treatments. When not at work he likes to swim, bike and run and completed his first 'Iron distance' triathlon in 2015.
Journal
The Lancet