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Clinical Articles, News & Views

Ultra-long-acting insulin reduces hypoglycaemia

The possibility of hypoglycaemia as a risk factor for cardiovascular events continues to be investigated and widely debated. There is therefore much interest in the development in insulins which are associated with fewer hypoglycaemic episodes.

An ultralong-acting basal insulin (insulin degludec, Novo Nordisk) has shown reduced rates of nocturnal hypoglycaemia compared to insulin glargine, in two studies1,2 published recently in The Lancet.

The two phase 3 studies included a total of 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. Both studies were ‘treat-to-target’ studies, patients achieving comparable improvements in glucose control in both studies, allowing researchers to closely determine the differences in the rates of hypoglycaemia.

“Hypoglycaemia is a major concern for both people with diabetes and their physicians and can often lead to under- and sub-optimal treatment”, said Professor Alan Garber (Baylor College of Medicine, Houston, USA), lead author of one of the papers. “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-yr);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/year and 1.4 vs. 1.8 episodes/year respectively).

“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 promise of insulin degludec as the ultra-long acting basal insulin which offers glycaemic control with a reduced risk of hypoglycaemia in people with diabetes using basal insulin analogues”.

Insulin degludec was submitted 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.

Hypos and cardiovascular events

Larger clinical trials looking for a causal relationship between hypoglycaemia and cardiovascular events, and the mechanisms that might be involved, are required according to a study published recently in Diabetes Care.3

American and Italian researchers reviewed the literature and results from randomised trials on the degree of glycaemic control required to decrease diabetes complications and the role of hypoglycaemia in cardiovascular morbidity and mortality.

References

1. Garber AJ, King AB, Del Prato S et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN™ Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. The Lancet. 2012;379:1498–507.

2. Heller S, Buse J, Fisher M et al. Insulin degludec, an ultra-long acting basal insulin, versus insulin glargine in basal bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN™ Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. The Lancet. 2012;379:1489–97.

3. Desouza CV, Bolli GB, Fonseca V. Hypoglycemia, diabetes, and cardiovascular events.  Diabetes Care 2010;33:1389–94. doi: 10.2337/dc09-2082

Published on: May 24, 2012

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