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Novo Nordisk's diabetes drug misses main goal in trial against Sanofi's Toujeo

Novo Nordisk A/S said its medicine Tresiba cut the risk of low blood sugar in adults with type 2 diabetes, although the results of the trial against a rival product from Sanofi fell short of the main goal.

In a phase 3 trial named Conclude, Novo's Tresiba, or insulin degludec, was evaluated against insulin glargine U300 — sold as Toujeo by Sanofi — in 1,609 adults with type 2 diabetes. The main goal of the study was testing whether Tresiba was better at lowering the rate of overall symptoms of hypoglycemia, or low blood sugar, at the end of 36 weeks of maintenance therapy.

Hypoglycemia occurs when blood sugar levels are low and cannot provide the body's organs with the energy they need. Symptoms include sweating, increased heart rate and difficulty with concentration and speech. Severe cases can lead to seizures, coma and death.

At the 36-week point of the trial, the rate of hypoglycemia symptoms was lower for Tresiba-treated patients than those taking Toujeo, but the result was not statistically significant, Novo said. During the total treatment period, which lasted up to 88 weeks, Tresiba was significantly better than Toujeo at reducing hypoglycemia rates.

The trial showed that Tresiba lowered the rate of severe hypoglycemia by 80% and the symptoms of hypoglycemia during sleep by 37% compared to Toujeo during the maintenance period. The rates of severe hypoglycemia and symptomatic hypoglycemia during sleep were reduced by 62% and 43%, respectively, in the total treatment period.

The results were presented at the European Association for the Study of Diabetes meeting in Barcelona, Spain, on Sept. 19.