GATWICK, England, March 8, 2019 /PRNewswire/ -- Findings from ReFLeCT – a large non-interventional real-world study using patient diaries – were presented today at the Diabetes UK Professional (DUK) 2019 Conference in Liverpool, UK. The ReFLeCT study demonstrated that people with type 1 or type 2 diabetes who were switched by their doctor to Tresiba® (insulin degludec) in routine clinical care from other basal insulins, had a significantly reduced rate of hypoglycaemia (low blood sugar).[1,2]
During the 12-month follow-up there were found to be significantly lower rates of overall, non-severe and nocturnal hypoglycaemia when switching to insulin degludec compared to baseline, in both groups (556 people with type 1 diabetes and 611 people with type 2 diabetes).[1,2] In addition, a secondary endpoint showed a significant reduction in blood glucose levels (HbA1c and fasting plasma glucose (FPG), which was experienced in both people with type 1 diabetes (HbA1c: -1.64 mmol/mol [-0.15%] and type 2 diabetes (HbA1c: -3.50 mmol/mol [-0.32%]). However, the clinical trial programme has shown similar glycaemic control with insulin degludec versus other basal insulins.
"ReFLeCT was the first prospective trial assessing the clinical effects of switching to insulin degludec from other basal insulins as part of routine care," said Professor Michael Feher, UK investigator for ReFLeCT and Consultant Physician at Chelsea and Westminster Hospital.
"The trial confirmed real world evidence of reduced hypoglycaemia following the switch to insulin degludec. This study extends the data from randomised control trials and previous real world studies of insulin degludec."
These results reinforce the effectiveness of insulin degludec, which has already been established through its extensive clinical trial programme, where insulin degludec has consistently shown a lower risk of hypoglycaemia at similar efficacy levels against insulin glargine 100 units/mL. Furthermore, a randomised controlled trial has shown similar glycaemic control and similar hypoglycaemia rates with insulin degludec versus insulin glargine 300 units/ml in patients with type 2 diabetes.
ReFLeCT (Results From Real-World Clinical Treatment with Tresiba® ) is the first long-term, prospective, non-interventional, real-world evidence study examining the safety and effectiveness of insulin degludec when used in routine clinical care, in people with type 1 (n=556) or type 2 (n=611) diabetes whose physician switched their basal insulin to insulin degludec. The observational study included a 4-week baseline period on the pre-switch basal insulin, followed by a 12-month observation period during which participants were on the study treatment (insulin degludec). The primary endpoint was the change in the rate of any hypoglycaemic episodes, recorded in patient diaries. The study was conducted in seven European countries: Denmark, the Netherlands, Spain, Sweden, Switzerland, Italy and the United Kingdom.[1,2] Clinicaltrials.gov: NCT02392117.
About insulin degludec
Insulin degludec is a once-daily basal insulin that provides a duration of action beyond 42 hours with a flat and stable glucose-lowering effect. In clinical trials, insulin degludec showed a lower risk of hypoglycaemia at similar glycaemic control against insulin glargine 100 units/mL. Insulin degludec received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It is commercially available in more than 61 countries.
About Novo Nordisk
Novo Nordisk is a global healthcare company with 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 43,200 people in 79 countries and markets its products in more than 170 countries. For more information, visit novonordisk.co.uk.
- Fadini GP, Feher M, Hansen TK et al. Reduced rates of overall hypoglycaemia in patients with Type 1 diabetes after switching to insulin degludec: a European, multinational, multicentre, prospective, observational study (ReFLeCT). Poster presented at the Diabetes UK Professional Conference, Liverpool, UK; 6-8 March 2019: P81.
- Fadini GP, Feher M, Hansen TK et al. Reduced rates of overall hypoglycaemia in patients with Type 2 diabetes after switching to insulin degludec: a European, multinational, multicentre, prospective, observational study (ReFLeCT). Poster presented at the Diabetes UK Professional Conference, Liverpool, UK; 6-8 March 2019: P82.
- Novo Nordisk Limited; Tresiba® Summary of Product Characteristics.
- Rosenstock Julio, et al, More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial. Diabetes Care 2018 Oct;41 (10):2147-2154.
SOURCE Novo Nordisk