Investigational ultra long-acting insulin degludec reduced rates of nocturnal hypoglycemia in type 2 diabetes patients versus insulin glargine

Philadelphia, PA, June 9, 2012 /PRNewswire/ — Ultra long-acting insulin degludec, an investigational insulin being developed by Novo Nordisk, significantly reduced the rate of hypoglycemia* 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 today at the 72nd Scientific Sessions of the American Diabetes Association (ADA).

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

“Nocturnal, or night-time, hypoglycemia 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 center 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 hypoglycemia.”

This randomized, 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 hypoglycemic 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 hypoglycemic rates were 1.52 versus 1.85 episodes per patient per year for insulin degludec and insulin glargine respectively (p=0.11).
• Overall severe hypoglycemia 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).

The most common adverse events of more than 5% are bronchitis, gastroenteritis, nasopharyngitis, upper respiratory tract infection, headache, diarrhea, vomiting, back pain, and cough.

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.
• Heise et. al.
• Altering the time of day of once-daily dosing of insulin degludec achieves similar glycemic control and safety compared to dosing the same time of day in people with type 1 diabetes.
• Russell-Jones et. al.
• Prospectively planned meta-analysis comparing hypoglycemic rates of insulin degludec with those of insulin glargine.
• Ratner et. al.

* Classified as low blood sugar occurring between 00:01 – 05:59 inclusive.
** Non-inferiority of change in HbA1c statistically confirmed in both studies. This study is a ‘treat-to-target’ study, 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, allowing researchers to closely determine the differences in the rates of hypoglycemia. HbA1c is the calculation used to measure blood glucose levels over a period of time.

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 program, BEGIN™, examining its impact on glucose control, hypoglycemia 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, Switzerland and a range of other countries.

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk-us.com.

© 2012 Novo Nordisk All rights reserved. 0412-00008770-1 June 2012

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