International clinical trial shows drug reduces risk of diabetes

The drug, liraglutide 3.0 mg may reduce diabetes risk by 80% in individuals with obesity and prediabetes according to the findings of an international study published today in The Lancet.

This 3-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.

Liraglutide is 97% similar to the naturally occurring human GLP-1 1. The drug promotes weight loss by interacting with the areas of the brain that control appetite and energy intake.

The participants 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 a regime of increased physical activity.

The study showed that 3 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 Carel le Roux from the UCD Diabetes Complications Research Centre, UCD School of Medicine and Fellow, UCD Conway Institute is an obesity specialist and the corresponding author on this article.

“In Ireland today, 1 in 10 of the population have prediabetes (fasting blood glucose 5.5 – 6.9mmol/L) 2. Prediabetes and obesity are risk factors for type 2 diabetes and its complications3. 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.

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.”

All of the patients involved in the study in Ireland were recruited through the HRB Clinical Research Facility at Galway University Hospital. Dr Francis Finucane, the lead investigator for the study at this facility said, “the reduction in risk of progression to diabetes from prediabetes is clearly desirable. The challenge now is to make these drugs available in an efficient and cost effective way to those patients who will benefit most from them.”

Journal Reference
3 years’ of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial. The Lancet. Published online February 22, 2017. Carel W le Roux, Arne Astrup, Ken Fujioka, Frank Greenway, David C W Lau, Luc Van Gaal, Rafael Violante Ortiz, John P H Wilding, Trine V Skjøth, Linda Shapiro Manning, Xavier Pi-Sunyer, for the SCALE Obesity and Prediabetes NN8022-1839 Study Group*
*A complete list of investigators in the Satiety and Clinical Adiposity – Liraglutide Evidence in individuals with and without diabetes (SCALE) Obesity and Prediabetes NN8022-1839 study group is provided in the Supplementary Appendix, available at thelancet.com

Acronym SCALE : Satiety and Clinical Adiposity-Liraglutide Evidence in Individuals with and without Diabetes

References
1. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. J Med Chem. 2000; 43(9):1664-1669.
2. https://www.diabetes.ie/about-us/diabetes-in-ireland/
3. Hu et al. Arch Intern Med 2004;164:892–6

About Prediabetes in Ireland
A VHI Healthcare Screening Projects tested 30,000 people for type 2 diabetes between 2009 and 2013 and showed that 17% of participants (nearly 5,000 people) had abnormal initial fasting blood sugar levels, 1.8% had undiagnosed diabetes and 10% had confirmed pre-diabetes.
Abnormal blood sugar levels, pre-diabetes and diabetes were more common in men than in women with men 2-3 times more likely to have abnormal blood sugar levels and undiagnosed diabetes
The study also found that the risk of having undiagnosed diabetes increased by 89% for every 5 KG / m2 increase in body mass index which demonstrates the importance of modifiable lifestyle factors in preventing diabetes.

About UCD Diabetes Complications Research Centre (DCRC)
DCRC researchers investigate the microvascular complications of diabetes. Research focuses on identifying novel drivers of disease progression, regression and genetic susceptibility with a view to identifying and developing innovative therapeutic paradigms and biomarkers. The DCRC comprises a multidisciplinary research group with expertise in molecular cell biology, genetics, bioinformatics, pharmacology, systems biology, chemical pathology and clinical medicine. Investigators at the UCD Conway Institute, St Vincent’s University hospital and the Mater Misericordiae University Hospital work closely with international collaborators in academia and industry. Research programmes are funded by national and international sources including Science Foundation Ireland (SFI), the European Union, Wellcome Trust, the National Institute of Health (NIH), the Juvenile Diabetes Research Foundation (JDRF), European Renal Association (ERA) and bio pharma industry.