Two phase 3 studies on ultra-long-acting insulin degludec published today in The Lancet

Copenhagen, Denmark – Ultra-long-acting insulin degludec, an investigational compound from Novo Nordisk, has been featured in two studies in The Lancet showing a significant reduction in the rates of nocturnal hypoglycemia* 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.1,2 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 hypoglycemia.1,2

“Hypoglycemia is a major concern for both people with diabetes and their physicians and can often lead to under- and sub-optimal treatment,” said Alan Garber, MD, Professor, Departments of Medicine, Baylor College of Medicine, Houston, Texas, USA and lead author of one of the papers published in The Lancet. “Of particular concern are hypoglycemic events that occur in the overnight hours during sleep when patients are unaware and therefore unable to take measures to reverse it. Newer insulins such as insulin degludec may be able to mitigate this concern.”

In type 2 patients, a significantly lower rate of overall hypoglycemic events was seen in the insulin degludec group, compared to those taking insulin glargine (11.1 vs. 13.6 episodes/patient-yr)1; in type 1 diabetes this figure was comparable between the two treatment arms. The rate of hypoglycemia 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/year and 1.4 vs. 1.8 episodes/year respectively).1,2

“We are proud that The Lancet has recognized the clinical potential of insulin degludec by publishing these two pivotal studies,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. “Novo Nordisk is very excited about the potential of insulin degludec to lower the risk of hypoglycemia in people with diabetes using basal insulin analogues.”

In both studies, insulin degludec effectively improved HbA1C and was non-inferior to insulin glargine in basal-bolus therapy in type 1 and type 2 diabetes. The most common adverse events occurring in more than 5% of patients in both studies included influenza, nasopharyngitis, upper respiratory tract infection, arthralgia, back pain, pain in extremity, headaches, diarrhea, peripheral edema, wrong drug administered, cough and hypertension across all treatment arms.

The complete studies can be found in the April 21st issue, Volume 379, of The Lancet and also online at: www.thelancet.com.

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, hypoglycemia and the possibility to flexibly adjust insulin degludec dosing time to suit patient needs. Insulin degludec has been submitted 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 and Switzerland.

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 Sperling Klaus Bülow Davidsen
Tel: (+45) 4442 6718 Tel: (+45) 4442 3176
krsp@novonordisk.com
klda@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. 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.

 

Posted: April 2012

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