Investigational ultra-long-acting insulin degludec reduces rates of nocturnal hypoglycaemia in type 2 diabetes patients versus insulin glargine...

Ultra-long-acting insulin degludec, (see structure) an investigational insulin being developed by Novo Nordisk, 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. This phase 3a study was presented  at the 72^nd Scientific Sessions of the American Diabetes Association (ADA). 

The study also found that insulin degludec had significantly lower rates of severe hypoglycaemia compared to insulin glargine.

"Nocturnal, or night-time, hypoglycaemia is a particular challenge for people living with diabetes, as these episodes are often unpredictable and difficult to detect", said Bernard Zinman, lead author and director of the diabetes centre at Mount Sinai Hospital, and professor of medicine, University of Toronto: "This study demonstrated that treatment with insulin degludec significantly reduced the rate of nocturnal hypoglycaemia". 

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.

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 HbA_1c 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.

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