Novo Nordisk said it has presented the global head-to-head trial called CONCLUDE, which compared Tresiba, a basal insulin analog injection, and Sanofi's insulin glargine U300.
It made the presentation at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD 2019) in Barcelona, Spain.
According to new data from the trial, Tresiba showed an overall lower risk of hypoglycemia, also known as hypo or low blood sugar, at a significantly lower HbA1c compared with insulin glargine in adults with type 2 diabetes who could not reach target blood sugar level using basal insulin with or without oral antidiabetic drugs (OADs).
The primary endpoint, the rate of overall symptomatic hypoglycemia in the maintenance period of 36 weeks, was numerically lower but not statistically significant versus insulin glargine U300. The rate of overall symptomatic hypoglycemia was significantly lower in favor of Tresiba during the total treatment period of up to 88 weeks.
Also, Tresiba significantly reduced the rate of severe hypoglycemia by 80 percent and nocturnal symptomatic hypoglycemia by 37 percent compared with insulin glargine U300 during the maintenance period, and by 62 and 43 percent, respectively, in the total treatment period.
Novo Nordisk’s Tresiba is a once-daily, ultralong-acting basal insulin analog injection to treat people with type 1 or type 2 diabetes. The treatment forms a multi-hexamer under subcutaneous injection and has a uniform blood glucose-lowering effect for more than 42 hours. A 3 mL injection costs 16,876 won ($15) in Korea.
The share of participants experiencing hypoglycemia was also significantly lower in favor of Tresiba in both the maintenance and total treatment periods for all hypoglycemia endpoints. These reductions in rates and proportions of patients experiencing hypoglycemia with Tresiba were seen alongside significant decreases from baseline in HbA1c and fasting plasma glucose
The company also confirmed that Tresiba showed a 12 percent lower insulin dose requirement with an end-of-trial mean daily insulin dose of 67U, compared with 73U for insulin glargine U300.
"Severe hypoglycemia 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, the lead investigator for the CONCLUDE study. "The results of this trial reinforce the safety profile of Tresiba as it demonstrated a significant reduction in severe hypoglycemia compared to insulin glargine U300 alongside effective blood glucose control."
Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, also said, "We are delighted that the findings of the CONCLUDE trial support what we have seen previously across the Tresiba clinical development program.
The findings offer further confidence that Tresiba can help people with type 2 diabetes reduce their risk of hypoglycemia, without having to compromise their treatment goals, Thomsen added.