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Investigational ultra-long-acting insulin degludec reduces rates of nocturnal hypoglycaemia in type 2 diabetes patients versus insulin glargine (9 Jun 2012)

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Philadelphia, PA – Ultra-long-acting insulin degludec, 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 today at the 72nd Scientific Sessions of the American Diabetes Association (ADA).1

The study also found that insulin degludec had significantly lower rates of severe hypoglycaemia compared to insulin glargine.1

“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:1

·         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.1

 

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.4 (Ratner et al)

*Classified as low blood sugar occurring between 00:01 – 05:59 inclusive.

**Non-inferiority of change in HbA1c statistically confirmed. 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 hypoglycaemia. 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 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. 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 haemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk.com.

 

Further information
Media:


Investors:

 

 

Katrine Rud von Sperling

Kasper Roseeuw Poulsen

Tel: (+45) 4442 6718

Tel: (+45) 4442 4303

krsp@novonordisk.com

krop@novonordisk.com

 

 

 

Frank Daniel Mersebach

 

Tel: (+45) 4442 0604

 

fdni@novonordisk.com

 

 

 

Lars Borup Jacobsen

 

Tel: (+45) 3075 3479

 

lbpj@novonordisk.com

 

 

In North America:

 

Ambre Morley

Jannick Lindegaard

Tel: (+1) 609 216 5240

Tel: (+1) 609 786 4575

abmo@novonordisk.com

jlis@novonordisk.com

 

References

1. Zinman B, et al. The Effect of Insulin Degludec on Glycemic Control and Nocturnal Hypoglycemia Compared with Insulin Glargine: A 1-year Randomized Trial in Insulin-naive People with Type 2 Diabetes. Poster (1047-P) presented at the 72nd Scientific Sessions of the American Diabetes Association, 9 June 2012. (NN1250-3579)

2. Heise T, et al. Insulin Degludec 200 U/ml is Ultra-Long-Acting and has a Flat and Stable Glucose-Lowering Effect. Oral presentation (349-OR) presented at the 72nd Scientific Sessions of the American Diabetes Association, 11 June 2012. (NN1250-1987)

3. Russell-Jones D, 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. Oral presentation (348-OR) presented at the 72nd Scientific Sessions of the American Diabetes Association, 11 June 2012. (NN1250-3770b)

4. Ratner R, et al. Prospectively Planned Meta-Analysis comparing Hypoglycemia Rates of Insulin Degludec with those of Insulin Glargine. Poster (387-P) presented at the 72nd Scientific Sessions of the American Diabetes Association, 10 June 2012.

 

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