Tresiba Showed an Overall Lower Risk of Hypoglycaemia and Significantly Lower HbA1c When Compared to Insulin Glargine U300

According to new data from the CONCLUDE head-to-head trial, Tresiba(R) (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(R) during the total treatment period of up to 88 weeks.1

In this head-to-head trial, Tresiba(R) 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 period when 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(R) as it demonstrated a significant reduction in severe hypoglycaemia compared to insulin glargine U300 alongside effective blood glucose control.”

The proportion of participants experiencing hypoglycaemia was also significantly lower in favour of Tresiba(R) during both the maintenance and total treatment periods for all hypoglycaemia endpoints. These reductions in rates and proportions of patients experiencing hypoglycaemia with Tresiba(R) 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(R) 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(R) clinical development programme,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “These findings offer further confidence that Tresiba(R) 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(R) 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 (

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