Novo Nordisk says Tresiba reduces hypoglycaemia risk vs Lantus
pharmafile | February 23, 2016 | News story | Manufacturing and Production, Research and Development | Novo Nordisk
Novo Nordisk has announced trial results suggesting that its drug Tresiba (insulin degludec) carries a reduced risk of hypoglycaemia episodes, compared to Sanofi’s Lantus (insulin glargine), in patients with type 1 diabetes.
In SWITCH 1, the second of two 2×32-week randomised, double-blind trials, 501 people with type 1 diabetes were randomised to cross-over treatment with Tresiba and insulin glargine in combination with insulin aspart. The timing of the daily injections of both Tresiba and insulin glargine was randomised equally to take place either in the morning or evening.
Tresiba matched Lantus for blood sugar reduction, and also demonstrated an 11% reduction in the rate of severe or blood glucose confirmed symptomatic hypoglycemia, with 2,201 events per 100 patient years for Tresiba, compared to 2,463 events per 100 patient years for insulin glargine.
Non-inferiority was also demonstrated for nocturnal hypoglycaemia: Tresiba reducing these incidences by 36% compared with Lantus, at 277 events versus 429.
In addition, during the maintenance period, the proportion of patients experiencing severe hypoglycaemia was 10% for Tresiba, and 17% for insulin glargine. The rates of severe hypoglycaemia were 69 and 92 events per 100 patient years exposed, respectively, representing a statistically-significant 35% reduction.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, says: “We are very excited about these trial results, which document that Tresiba, also in people with type 1 diabetes, significantly reduces the risk of hypoglycaemia compared to insulin glargine. We expect to initiate filing of the data from the SWITCH trials with regulatory authorities in Q3 2016 with the aim of updating the label for Tresiba.”
Joel Levy
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