Tresiba® Showed an Overall Lower Risk of Hypoglycaemia and Significantly Lower HbA1c When Compared to Insulin Glargine U300 in People With Type 2 Diabetes

BARCELONA,Spain,Sept. 19,2019 -- According to new data from the CONCLUDE head-to-head trial,Tresiba® (insulin degludec) showed an overall lower risk of hypoglycaemia,also known as a hypo or low blood sugar,at a significantly lower HbA1c,compared with insulin glargine U300 in adults with type 2 diabetes uncontrolled on basal insulin with or without oral anti-diabetic drugs (OADs). Results from the CONCLUDE trial were presented today at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD 2019) in Barcelona,Spain.1

The primary endpoint,the rate of overall symptomatic hypoglycaemia in the maintenance period of 36 weeks which was tested for superiority,was numerically lower but not statistically significant versus insulin glargine U300. The rate of overall symptomatic hypoglycaemia was statistically significantly lower in favour of Tresiba®during the total treatment period of up to 88 weeks.1

In this head-to-head trial,Tresiba® significantly reduced the rate of severe hypoglycaemia by 80% and nocturnal symptomatic hypoglycaemia by 37% when compared with insulin glargine U300 during the maintenance period,and by 62% and 43% respectively in the total treatment periodwhen compared with insulin glargine U300.1

"Severe hypoglycaemia can be very worrying and potentially dangerous for people with diabetes and is important to consider as part of long-term diabetes care," said Dr Athena Philis-Tsimikas,CONCLUDE lead investigator and corporate vice president,Scripps Whittier Diabetes Institute."The results of this trial reinforce the safety profile of Tresiba® as it demonstrated a significant reduction in severe hypoglycaemiacompared to insulin glargine U300 alongside effective blood glucose control."

The proportion of participants experiencing hypoglycaemia was also significantly lower in favour of Tresiba®during both the maintenance and total treatment periods for all hypoglycaemia endpoints.These reductions in rates and proportions of patients experiencing hypoglycaemia with Tresiba® were seen alongside significant reductions from baseline in HbA1c (estimated treatment difference [ETD] -0.1%) and fasting plasma glucose (ETD -0.62 mmol/L). Furthermore,Tresiba® showed a 12% lower insulin dose requirement with an end-of-trial mean daily insulin dose of 67U,compared with 73U for insulin glargine U300.1

"We are delighted that the findings of the CONCLUDE trial support what we have seen previously across the Tresiba® clinical development programme," said Mads Krogsgaard Thomsen,executive vice president and chief science officer of Novo Nordisk. "These findings offer further confidence that Tresiba® can help people with type 2 diabetes reduce their risk of hypoglycaemia,without having to compromise their treatment goals."

About the CONCLUDE trial

The CONCLUDE clinical trial (NCT03078478) was a randomised,open-label,treat-to-target,multinational trial comparing the risk of hypoglycaemia with Tresiba® vs insulin glargine U300 in 1,609 adults with type 2 diabetes. Both treatments were administered once daily,with or without oral anti-diabetic drugs (OADs),in insulin-experienced participants.Endpoints were assessed during a 36-week maintenance period and a total treatment period of up to 88 weeks.1

The primary endpoint was the overall number of severe (defined as an event requiring third party assistance) or blood glucose confirmed (<3.1 mmol/L) symptomatic hypoglycaemic episodes during the maintenance period. Secondary hypoglycaemia endpoints included the number of nocturnal symptomatic and the number of severe hypoglycaemic events during the maintenance period,as well as basal insulin dose (U) at end of treatment. Other endpoints included change from baseline to end of treatment in HbA1c and fasting plasma glucose (FPG) level and all three hypoglycaemia endpoints during the total treatment period.1

About hypoglycaemia

Hypoglycaemia is when blood sugar levels are too low and cannot provide the body's organs with the energy they need. Hypoglycaemia can cause a range of symptoms including confusion,trembling,sweating,increased heart rate,difficulty with concentration and speech,and in severe cases it can lead to seizures,coma or even death.2-5

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.6,7Tresiba® led to an effective reduction in HbA1c in clinical trials and showed a lower risk of hypoglycaemia in studies compared to insulin glargine U100,in particular in type 2 diabetes. It also provides a lower day-to-day variability in glucose lowering effect versus insulin glargine U100 and insulin glargine U300.8,9Tresiba® 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.

Novo Nordisk is a global healthcare company with more than 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 41,600 people in 80 countries and markets its products in more than 170 countries. For more information,visit novonordisk.com,Facebook,Twitter,LinkedIn,YouTube.

References

Philis-Tsimikas A,Klonoff DC,Khunti K,et al. CONCLUDE: a trial COmparing the efficacy aNd safety of insulin degLUDEc and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin and oral antidiabetic drugs. Symposium at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD),Barcelona,Spain; 16-20 September 2019.

Seaquist ER,Anderson J,Childs B,et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36:1384-95.

International Hypoglycaemia Study Group. Diagnosis of hypoglycaemia. Available online at http://ihsgonline.com/understanding-hypoglycaemia/diagnosis. Last accessed: July 2019.

Cryer PE. Hypoglycemia,functional brain failure,and brain death. J Clin Invest. 2007; 117:868-870.

Ahrén B. Avoiding hypoglycemia: a key to success for glucose-lowering therapy in type 2 diabetes. Vasc Health Risk Manag. 2013; 9:155-163.

EMA. Tresiba® 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: July 2019.

Haahr H and Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014; 53:787–800.

Heise T,Hermanski L,Nosek L,et al. Insulin degludec: Four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012; 14:859-864.

Heise T,Norskov M,et al. Insulin degludec: Lower day-to-day and within-day variability in pharmacodynamic response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab. 2017; 19:1032-1039.

Further information

Media:

Mette Kruse Danielsen

+45 3079 3883

mkd@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45 3075 9085

phak@novonordisk.com

Valdemar Borum Svarrer

+45 3079 0301

jvls@novonordisk.com

Ann Søndermølle Rendbæk

+45 3075 2253

arnd@novonordisk.com