Levemir(R) Demonstrates A 24-hour Duration Of Action And Significant Weight Loss In Obese Patients - New Studies Announced

Main Category: Obesity / Weight Loss / Fitness
Article Date: 11 Sep 2008 - 2:00 PDT


Data released at the European Association for the Study of Diabetes (EASD) Annual Meeting concludes that Levemir® (insulin detemir [rDNA origin] injection) is a once-daily treatment for diabetes patients after demonstrating a 24-hour duration of action in both type 1 and type 2 diabetes.1,2 Results from two other studies announced today reveal that Levemir® can lead to significant weight loss for insulin-naïve patients with type 2 diabetes3, and provides a similar blood glucose response as glargine with no significant difference in daily average consumption (DACON) or diabetes-related pharmacy costs4.

Once-daily Levemir® demonstrates 24-hour duration of action

The randomised, double-blind study by Bock et al1 demonstrates that once-daily Levemir® is effective over a 24-hour period (mean duration 23.3 hours) in type 1 diabetes patients and has a more consistent duration of action compared to insulin glargine1. This reflects other published research in which patients with type 2 diabetes achieve 24-hour glycaemic control with once-daily Levemir®.5

Weight benefit beyond glycaemic control

In another study presented today, a subset analysis of the PREDICTIVE™ study3, it was shown that insulin-naïve patients with type 2 diabetes and a BMI >35 kg/m2 experienced an average weight loss of up to -3.46 kg after 52 weeks of Levemir® treatment3.

"This data confirms that Levemir® provides a significant weight benefit for overweight or obese patients who are being initiated into insulin treatment. This weight advantage is important because weight gain is a common barrier to insulin initiation," said Professor Helene Hanaire, Hospital Rangueil, Toulouse, France. "This weight advantage combined with the efficacy and convenience of Levemir®, which can be taken once daily, makes it a good option for overweight or obese diabetes patients who need to take insulin."

Levemir® shows similar daily average consumption versus glargine

A retrospective analysis of insulin-naïve patients with type 2 diabetes enrolled in a major US health plan compared daily average consumption (DACON) of and glycaemic control with the insulins Levemir® and glargine, along with associated medical costs. Results showed that there was no difference in HbA1c values between Levemir® and insulin glargine cohorts, and no significant difference in DACON4.

About Levemir® (insulin detemir [rDNA origin] injection)

Levemir® (insulin detemir [rDNA origin] injection) is a long-acting modern insulin (insulin analogue) indicated for once- or twice-daily subcutaneous administration for the treatment of adults and children with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycaemia. Levemir® has a relatively flat action profile with up to 24-hour duration of action. It can be added to oral antidiabetic agents, or used in combination with rapid-acting insulin. Levemir® is available in FlexPen®, a prefilled insulin pen for easy, discreet dosing, and in vials. The dose should be taken in the evening, at dinner or before bedtime. Levemir® has been available for use in Europe since March 2004 and is currently approved in more than 50 countries worldwide.

Prescribing information for Levemir® is available by contacting Novo Nordisk or visiting http://www.novonordisk.com.

Levemir® and FlexPen® are registered trademarks of Novo Nordisk A/S.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 26,300 employees in 80 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit http://www.novonordisk.com.

References

1. Bock, G., et al. Pharmacodynamics and pharmacokinetics of long-acting insulin analogues detemir and glargine after 7 days of use and after its first administration in subjects with type 1 diabetes. Presented at the European Association for the Study for Diabetes, September 2008.

2. King, A B., et al. A randomized, crossover, double-blind comparison of insulin detemir and insulin glargine daily blood glucose profiles in subjects with type 2 diabetes. Presented at the American Diabetes Association's 68th Annual Scientific Sessions, June 2008 and at the European Association for the Study for Diabetes, September 2008.

3. Hanaire, H., et al. Insulin-naïve patients with type 2 diabetes and higher BMI experience weight loss when initiated onto insulin detemir: 12-week, 26-week and 52-week follow-up data from PREDICTIVE™. Presented at the European Association for the Study for Diabetes, September 2008.

4. Borah, B., et al. Comparative analysis of treatment outcomes of patients on insulin detemir (Levemir®) and insulin glargine (Lantus®). Presented at the American Diabetes Association's 68th Annual Scientific Sessions, June 2008 and at the European Association for the Study for Diabetes, September 2008.

5. Heise, T, Pieber, T. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes, Obesity and Metabolism 2007;9(5):648-659.

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