Switching to TresibaR Benefits People with Diabetes Irrespective of Blood Sugar Levels in a Real-world Setting

– Switching to TresibaR from another basal insulin benefits people with diabetes regardless of whether or not their blood sugar levels are controlled.[1] This is the conclusion of a post-hoc analysis of data from the EU-TREAT study collected in a real-world clinical setting among people with type 1 and type 2 diabetes.

In people with type 2 diabetes whose blood sugar levels were controlled (HbA1c ≤7.5%) with basal insulin prior to switching, TresibaR significantly reduced the rate of hypoglycaemia (low blood sugar levels) while maintaining blood sugar control. Results showed a 67% reduction in the rate of hypoglycaemic events over six months after switching to TresibaR, with an 11% lower dose of insulin.[1]

In patients with uncontrolled type 1 or type 2 diabetes, switching to TresibaR resulted in significantly improved glycaemic control without an increase in the risk of hypoglycaemia or insulin dose.[1][2] These results were sustained for up to 12 months after switching from another basal insulin, mainly insulin glargine U100 and insulin detemir.[1]

In people with type 1 diabetes whose blood sugar levels were controlled, a 16% lower rate of hypoglycaemia was observed over six months, and blood sugar control was maintained with a 13% lower dose of insulin.[1]

“This new analysis shows that people with diabetes who have switched to TresibaR in the real world benefit from this change, regardless of whether they did so to improve blood glucose control or reduce the risk of hypoglycaemia,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. “This confirms that the benefits of TresibaR seen in clinical trials are being reproduced in clinical practice.”

The main results of the EU-TREAT real-world evidence study reported earlier this year showed that that people with type 1 and type 2 diabetes experienced a significant reduction in HbA1c six months after switching to TresibaR. Rates of overall hypoglycaemia were also significantly lower at six months after switching to TresibaR. In people with type 1 diabetes, the rate of severe hypoglycaemia was reduced by 85% and by 92% in people with type 2 diabetes. Similar reductions were seen at 12 months.[2,3]

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 TresibaR from another basal insulin in people with type 1 (n=1,717) and type 2 (n=833) diabetes. Patients in Austria, Denmark, Germany, Greece, Italy and Switzerland were switched from another basal insulin to TresibaR 6 months prior to data collection. Outcome measurements were collected at 6?3 and 12?3 months after initiation on TresibaR and was compared to baseline measurement taken from the prior basal insulin during a 3-month period prior to initiation on TresibaR. [2,3]

About Tresiba[R]

TresibaR (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 variability in blood glucose levels 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, TresibaR allows for flexibility in day-to-day dosing time with a minimum of eight hours between injections.[5] TresibaR 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 Novo Nordisk

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 obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 41,700 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube .

Further information

Media: Katrine Sperling +45-4442-6718 [email protected] ?sa Josefsson +45-3079-7708 [email protected] Investors: Peter Hugreffe Ankersen +45-3075-9085 [email protected] Hanna Ogren +45-3079-8519 [email protected] Anders Mikkelsen +45-3079-4461 [email protected] Christina Kj?r +45-3079-3009 [email protected] Kasper Veje (US) +1-609-235-8567 [email protected]

References

1. Novo Nordisk. EU-TREAT post hoc analysis. Data on file. 2017. 2. 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. 77th Annual Scientific Sessions of the American Diabetes Association (ADA), San Diego, California, US. June 2017. 3. 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. 77th Annual Scientific Sessions of the American Diabetes Association (ADA), San Diego, California, US. June 2017. 4. EMA. TresibaR Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002498/WC500138940.pdf. Last accessed: December 2017. 5. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014; 53:787-800. 6. Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med. 2017; 377:723-732.

ZINC ID: HQMMA/TB/0917/0327: December 2017

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