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Phase 2 Data for Ultra-Long-Acting Insulin Degludec Shows the Potential to Effectively Lower Blood Sugar, Including When Used Three Times a Week

Saturday, June 26, 2010 Research News J E 4
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ORLANDO, Fla., June 25 Novo Nordisk today presented phase 2 proof-of-concept data for its investigational insulin degludec, an ultra-long-acting basal insulin, which demonstrated the potential to help achieve target glycemic control when used once daily or three times weekly. These data were presented at the 70th Scientific Sessions of the American Diabetes Association (ADA).(1)

These phase 2 studies showed that insulin degludec helped improve glucose control. In one study, after 16 weeks of treatment with insulin degludec, mean HbA1c reductions were similar across the once-daily and three-times-weekly insulin degludec groups (-1.3% and -1.5% respectively) and comparable to insulin glargine (-1.5%).(2)

In this study, 77% of patients treated with insulin degludec three times weekly did not experience any confirmed hypoglycemia (defined as low blood glucose levels or episodes that required assistance). This result was similar in the study arm using insulin glargine once daily. Of those patients using insulin degludec once daily, 92% did not experience any confirmed hypoglycemia. A formal statistical test was not possible due to low number of patients in this study (60-62 in each arm).

"Insulin degludec has shown the potential to help deliver improvements in glycemic control with less than one daily injection," said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. "The low rate of hypoglycemia after once-daily insulin degludec administration, as well as the potential to be used three times weekly in people with type 2 diabetes will be further evaluated in our pivotal phase 3 trials in the BEGIN(TM) and BOOST(TM) programs."

Insulin degludec/insulin aspart (IDegAsp), a combination-insulin with insulin degludec and insulin aspart, is being tested in the BOOST(TM) program. It is being studied for its ability to provide the ultra-long-acting basal coverage of insulin degludec as well as a bolus boost to cover the meal coinciding with the injection. Phase 2 data presented at ADA showed that IDegAsp once daily brought the majority of patients to ADA-recommended glycemic targets (<7% HbA1c) without confirmed major hypoglycemia after 16 weeks of treatment.(3) In this proof-of-concept trial, there were 60 patients taking insulin glargine and 59 on IDegAsp with comparable glycemic control.

Novo Nordisk is exploring the clinical profile of insulin degludec and IDegAsp in one of the largest ever phase 3a clinical trial programs in the field of insulin therapy, BEGIN(TM) and BOOST(TM), with more than 10,000 patients.

Adverse events

The most common adverse events were headache, diarrhea and nasopharyngitis; and most were mild to moderate in severity.

About the mode of action

Insulin degludec is an investigational insulin molecule that has a distinct mode of action that provides a smooth and stable profile. The ultra-long clinical profile is derived from the soluble multi-hexamer formation and the continuous slow and stable release of insulin degludec monomers.(1)

Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs more than 29,300 employees in 76 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk-us.com.

References

1. Jonassen, I et al. Insulin Degludec is a new generation ultra-long-acting basal insulin with a unique mechanism of protraction based on multi-hexamer formation. Oral Presentation no. 39-OR, presented at the American Diabetes Association (ADA) Scientific Sessions 2010, Orlando, Florida. June 2010. 2. Zinman, B et al. Insulin degludec, a new generation ultra-long acting insulin used once-daily or three times weekly in people with type 2 diabetes: Comparison to insulin glargine. Oral Presentation no. 40-OR, presented at the American Diabetes Association (ADA) Scientific Sessions 2010, Orlando, Florida. June 2010. 3. Heise, T et al. Once-daily use of a new generation, ultra-long acting basal insulin with a bolus boost in insulin naive people with type 2 diabetes: Comparison with insulin glargine. Oral Presentation no. 34-OR, presented at the American Diabetes Association (ADA) Scientific Sessions 2010, Orlando, Florida. June 2010.

SOURCE Novo Nordisk
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