Two phase 3 studies on ultra-long-acting insulin degludec published in The Lancet

Ultra-long-acting insulin degludec, an investigational compound from Novo Nordisk, has been featured in two studies in The Lancet showing a significant reduction in the rates of nocturnal hypoglycaemia* by 25%, compared to insulin glargine.

The two phase 3 studies included in total 1,635 participants and investigated insulin degludec compared to insulin glargine in a basal-bolus regimen in people with type 1 and type 2 diabetes.1,2 Both studies were ‘treat-to-target’ studies, meaning patient insulin doses were adjusted systematically to allow them to achieve a targeted fasting glucose level. As a result, patients, successfully achieved comparable improvements in glucose control** in both studies, allowing researchers to closely determine the differences in the rates of hypoglycaemia.1,2

“Hypoglycaemia is a major concern for both people with diabetes and their physicians and can often lead to under- and sub-optimal treatment”, said Alan Garber MD, Professor, Departments of Medicine, Baylor College of Medicine, Houston, Texas, USA and lead author of one of the papers published in The Lancet. “Of particular concern are hypoglycaemic events that occur in the overnight hours during sleep when patients are unaware and therefore unable to take measures to reverse it. Newer insulins such as insulin degludec may be able to mitigate this concern.”

In type 2 patients, a significantly lower rate of overall hypoglycaemic events was seen in the insulin degludec group, compared to those taking insulin glargine (11.1 vs. 13.6 episodes/patient-year)1; in type 1 diabetes this figure was comparable between the two treatment arms. The rate of hypoglycaemia at night* was 25% lower in both type 1 and type 2 diabetes for patients treated with insulin degludec, compared to those taking insulin glargine (4.4 vs. 5.9 episodes/patient-year and 1.4 vs. 1.8 episodes/patient-year respectively).1,2

“We are proud that The Lancet has recognized the clinical potential of insulin degludec by publishing these two pivotal studies,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. “Novo Nordisk is very excited about the potential of insulin degludec to lower the rates of hypoglycaemia in people with diabetes using basal insulin analogues.”

The complete studies can be found in the April 21st issue, Volume 379 of The Lancet and also online at: www.thelancet.com.

About insulin degludec

Insulin degludec is an ultra-long-acting basal insulin analogue discovered and developed by Novo Nordisk. Insulin degludec has a distinct slow absorption which provides a flat and stable action profile. Insulin degludec has been studied in a large-scale clinical trial programme, BEGIN™, examining its impact on glucose control, hypoglycaemia and the possibility to flexibly adjust insulin degludec dosing time to suit patient needs. Insulin degludec has been submitted for once-daily use to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in September 2011 for regulatory review. In addition, insulin degludec has been submitted for regulatory approval in Japan, Canada and Switzerland.

References

1. Garber AJ, King AB, Del Prato S et al. The BEGIN Basal-Bolus Type 2 Trial: Insulin degludec, an ultra-long-acting basal insulin, versus insulin glargine for basal-bolus therapy in type 2 diabetes: a 52-week, phase 3, randomised, parallel-group, multinational, treat-to-target trial. The Lancet. 2012: 379, pp 1498-507.
2. Heller S, Buse J, Fisher M et al. The BEGIN™ Basal-Bolus Type 1 Trial: Insulin degludec, an ultra-long-acting basal insulin, versus insulin glargine in basal-bolus therapy with mealtime insulin aspart in type 1 diabetes: a 52-week, phase 3, randomised, open-label, parallel-group, multinational, treat-to-target trial. The Lancet. 2012; 379, pp 1489-97