While the Danish drugmaker’s Tresiba (insulin degludec) didn’t fare as well as hoped in the head-to-head trial, Novo Nordisk was quick to point out that Tresiba showed an overall lower risk of hypoglycemia compared to Toujeo.
Novo Nordisk’s insulin Tresiba failed to hit its primary endpoint of superiority against Sanofi’s Toujeo in adults type2 diabetes patients whose disease is uncontrolled on basal insulin with or without oral anti-diabetic drugs.
While the Danish drugmaker’s Tresiba (insulin degludec) didn’t fare as well as hoped in the head-to-head trial, Novo Nordisk was quick to point out that Tresiba showed an overall lower risk of hypoglycemia compared to Toujeo. The head-to-head study data from the CONCLUDE trial was presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD 2019) in Barcelona on Thursday. The two companies have been going toe-to-toe for years developing treatments for diabetes patients.
Hypoglycemia is when blood sugar levels are too low and cannot provide the body’s organs with the energy they need. In severe cases it can lead to seizures, coma or even death.
Regarding the primary endpoint of superiority in overall symptomatic hypoglycemia in the maintenance period of 36 weeks, Novo said the numbers for Tresiba were numerically lower but not statistically significant from Toujeo. The rate of overall symptomatic hypoglycemia was statistically significantly lower in favor of Tresiba during the total treatment period of 88 weeks, the company said. To back up its point, Novo Nordisk said Tresiba significantly reduced the rate of severe hypoglycemia by 80% and nocturnal symptomatic hypoglycemia by 37% when compared to Toujeo during the 36 weeks period. Over the 88-week period, the numbers changed to 62% and 43% respectively, the company said.
Athena Philis-Tsimikas, the lead investigator for the CONCLUDE trial and a corporate vice president at the Scripps Whittier Diabetes Institute, pointed to the concerns of severe hypoglycemia in diabetes patients. Philis-Tsimikas said the results of the CONCLUDE 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.”
Novo noted that the proportion of participants experiencing hypoglycemia was also significantly lower in favor of Tresiba during both the maintenance and total treatment periods for all hypoglycemia endpoints. Also, Tresiba showed a 12% lower insulin dose requirement compared to Toujeo.
While the primary endpoint was not reached, Novo Nordisk Chief Science Officer Mads Krogsgaard Thomsen said the findings from the CONCLUDE trial “offer further confidence that Tresiba can help people with type 2 diabetes reduce their risk of hypoglycemia, without having to compromise their treatment goals.
