Findings from the real-world study, EU-TREAT (EUropean TREsiba AudiT), were presented today at the American Diabetes Association's 77^th Scientific Sessions (ADA) in San Diego, US. The study showed that people with type 1 diabetes and type 2 diabetes experienced a significant reduction in HbA_1c (-0.2% for type 1 diabetes and -0.5% for type 2 diabetes) six months after switching to Tresiba^® from another basal insulin, primarily insulin glargine U100 and insulin detemir, in a real-world setting. These results were sustained at 12 months.^[1],[2]

Rates of overall hypoglycaemia were also significantly lower at six months after switching to Tresiba^®. In people with type 1 diabetes, the rate of severe hypoglycaemia was reduced by 85% and by 92% in people with type 2 diabetes. Hypoglycaemia outcomes at 12 months were in line with these results.^[1],[2]

In addition, a significant reduction in fasting plasma glucose was observed at six months (-18.7 mg/dL for type 1 diabetes, and -23.7 mg/dL for type 2 diabetes) and maintained for 12 months.^[1],[2] The total daily insulin dose also decreased significantly in people with type 1 diabetes (-4.9 units) and type 2 diabetes (-2.5 units) at six months, and remained stable at 12 months.^[1],[2]

"Real-world studies are important to understand how outcomes from clinical trials translate into real-world practice," said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. "Our real-world data presented at ADA reinforce what we have seen in the clinical trial programme, demonstrating improved glycaemic control and significantly reduced risk of hypoglycaemia when patients switched to Tresiba^® from other basal insulins such as insulin glargine and insulin detemir."

Also presented at ADA were analyses from the US, using the IBM Explorys platform, that similarly assessed the clinical effectiveness of switching from any other basal insulin to Tresiba^® in people with type 2 diabetes. After switching to Tresiba^®, HbA_1c decreased significantly (-0.75%), and the percentage of people reaching their target HbA_1c of <7% more than doubled (increased from 5.3% to 12.4% at 90 days). In addition, the proportion of people who experienced one or more hypoglycaemic events decreased from 7.3% to 6.9% with Tresiba^®.^[3]

About Tresiba^® 

Tresiba^® (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.^[4],[5] It provides low within-day and day-to-day variability and a lower risk of overall, nocturnal and severe hypoglycaemia vs. insulin glargine U100.^[4],[6] On occasions when administration at the same time of day is not possible, Tresiba^® allows for flexibility in day-to-day dosing time with a minimum of eight hours between injections.^[4] Tresiba^® received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It is now commercially available in more than 50 countries.

About EU-TREAT   

EU-TREAT (EUropean TREsiba AudiT) is a European, multicentre, real-world evidence study (n=2,550) investigating the effect of switching to Tresiba^® from any other basal insulin in people with type 1 (n=1,717) and type 2 (n=833) diabetes. Patients were switched from any other basal insulin to Tresiba^® 6 months prior to data collection. Outcome measurements were collected at 6±3 and 12±3 months after initiation on Tresiba^® and was compared to baseline measurement taken from the prior basal insulin during a 3-month period prior to initiation on Tresiba^®.^[1],[2]

About the US real-world study   

The US real-world analysis is a retrospective cohort analysis using anonymised electronic records, medical billing and payor claims data from the IBM Explorys platform for people with type 2 diabetes (n=225). The IBM Explorys platform is a database which combines patient data from different sources across clinically integrated networks. People with type 2 diabetes who used a basal insulin 90 days prior to initiating Tresiba^® were included. Measurements were collected 90 days prior to, and 90±45 days after, initiating Tresiba^®.^[3]

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,000 people in 77 countries and markets its products in more than 165 countries.

References   

1. Siegmund T, Tentolouris N, Knudsen TS, et al. EU-TREAT 1: Switching to insulin degludec reduces the risk of hypoglycaemia in patients with T1DM in a real-world setting. Poster presentation. 77^th  American Diabetes Association (ADA), San Diego, California, US. June 2017.

2. Schultes B, Tentolouris N, Knudsen TS, et al.EU-TREAT 2: Switching to insulin degludec improves glycaemic control in patients with T2DM in a real-world setting. Poster presentation. 77^thAmerican Diabetes Association (ADA), San Diego, California, US. June 2017.

3. Tibaldi J, Hansen B, Wolden ML, et al. Real-world assessment of clinical effectiveness when switching to insulin degludec from another basal insulin among type 2 diabetes patients in the US. Poster presentation. 77^th American Diabetes Association (ADA), San Diego, California, US. June 2017.

4. EMA. Tresiba^® Summary of Product Characteristics.

5. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clinical Pharmacokinetics. 2014; 53:787-800.

6. Novo Nordisk. Tresiba^® demonstrates a safe cardiovascular profile and reduces the risk of severe hypoglycaemia compared to insulin glargine U100 in the DEVOTE trial.