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Clinical Trials

Date: 2012-06-09

Type of information:

phase: 3a

Announcement: presentation of results at the 72nd Scientific Sessions of the American Diabetes Association (ADA)

Company: Novo Nordisk (Denmark)

Product: insulin degludec

Action mechanism: 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.

Disease: type 2 diabetes

Therapeutic area: Metabolic diseases

Country:

Trial details: This randomised, open-label, non-inferiority, treat-to-target trial compared efficacy and safety of insulin degludec to insulin glargine. Both insulins were given once-daily in 1,030 insulin-naïve type 2 diabetes adults inadequately controlled with oral anti-diabetic medications.

Latest news:

Novo Nordisk has presented results of a phase 3a study of its investigational ultra-long-acting insulin degludec. Insulin degludec significantly reduced the rate of hypoglycaemia at night in adults with type 2 diabetes while obtaining equivalent improvement in glucose control compared with insulin glargine over a 52-week period.
The study also found that insulin degludec had significantly lower rates of severe hypoglycaemia compared to insulin glargine.
Findings of the study include:
• Nocturnal hypoglycaemic rates were significantly lower by 36% with insulin degludec than with insulin glargine (0.25 versus 0.39 episodes per patient per year; p=0.04).
• Overall confirmed hypoglycaemic rates were 1.52 versus 1.85 episodes per patient per year for insulin degludec and insulin glargine respectively (p=0.11).
• Overall severe hypoglycaemia was infrequent in both treatment populations, but it was significantly lower with insulin degludec than with insulin glargine (0.003 versus 0.023 episodes/patient-year; p=0.02).
• At one year, this noninferiority, treat-to-target trial demonstrated comparable HbA1c reductions with insulin degludec versus insulin glargine (-1.06% versus -1.19%).**
• Fasting plasma glucose (FPG) reductions were significantly greater with insulin degludec than with insulin glargine (-67.7 versus -59.5 mg/dl, estimated treatment difference (EDT) -7.7 mg/dl, p=0.005).
Overall adverse event rates were low and similar between groups.

Other insulin degludec studies presented at ADA include:
• Insulin degludec 200 U/ml is ultra-long-acting and has a flat and stable glucose-lowering effect.2 (Heise et al)
• Altering the time of day of once-daily dosing of insulin degludec achieves similar glycaemic control and safety compared to dosing the same time of day in people with type 1 diabetes.3 (Russell-Jones et al)
• Prospectively planned meta-analysis comparing hypoglycaemic rates of insulin degludec with those of insulin glargine.

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 (See http://biopharmanalyses.fr/product/?pageid=244). In addition, insulin degludec has been submitted for regulatory approval in Japan, Canada, Switzerland and a range of other countries.

Is general: Yes