Date: 2012-04-20
Type of information:
phase: 3
Announcement: publication of two phase 3 studies in The Lancet :
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
Company: Novo Nordisk (Denmark)
Product: insulin degludec (Degludec®)
Action mechanism: insulin degludec is an ultra-long acting basal insulin analogue
Disease: type 1 and type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: Novo Nordisk has announced that its ultra-long-acting insulin degludec 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.
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.
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) ; 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).
Insulin degludec has been submitted for once-daily use to the EMA and FDA in September 2011 for regulatory review (See http://biopharmanalyses.fr/product/?pageid=244). In addition, insulin degludec has been submitted for regulatory approval in Japan, Canada and Switzerland.
