SOURCE: Novo Nordisk

May 20, 2008 09:00 ET

New Studies Showed FlexPen® Was Superior to SoloSTAR® in Dose Accuracy

PRINCETON, NJ--(Marketwire - May 20, 2008) - Two independent studies showed that FlexPen® was more accurate when delivering insulin than SoloSTAR®, from sanofi-aventis.

One study was lead by Prof. Andreas Pfützner from IKFE, Institute for Clinical Research and Development in Germany, and the other was lead by Dr. Toshinari Asakura from the Niigata University of Pharmacy and Applied Life Sciences in Japan. The German study was published in the May 2008 issue of Diabetes Science and Technology and the Japanese study was published in the April 2008 issue of Current Medical Research & Opinion.

"We were surprised to see these dose deviations between the two pre-filled pens. It is important that the insulin devices are accurate," says Prof. Pfützner, who has been heading the German study.

Study findings

In both studies, acceptable limits for dose accuracy were based on International Organization for Standardization (ISO) definitions of +/-1 unit for a 5 unit dose, +/-1 unit for a 10 unit dose, and +/-1.5 unit for a 30 unit dose.

The German study tested the pens at two doses (10 unit and 30 unit). At both doses measured, Levemir® (insulin detemir [rDNA origin] injection) FlexPen® accurately delivered insulin with fewer deviations than Lantus® SoloSTAR®.

Average deviations in dose accuracy (%)
               FlexPen®      SoloSTAR®
             --------------  ---------------
10 unit       1.64 +/- 0.84% 2.61 +/- 0.92%*
             --------------  ---------------
30 unit       0.83 +/- 0.26% 1.70 +/- 0.84%*
             --------------  ---------------
* p < 0.05 vs FlexPen®

"The findings of these accuracy studies should be taken into account by doctors when choosing insulin and device," says Prof. Pfützner.

Findings from the Japanese study led by Dr. Asakura were consistent with those found in the German study. Results demonstrated fewer statistically significant deviations from the set dose with Levemir® FlexPen® than with Lantus® SoloSTAR® at the three doses (5 units, 10 units and 30 units; p < .05, p < .001, p < .001, respectively) tested in the study.

In both studies, the insulin pens were prefilled with their respective brands of insulin: Levemir® (insulin detemir [rDNA origin] injection) FlexPen®); Lantus® (insulin glargine) SoloSTAR®).

Prescribing Information for Levemir® is available by contacting Novo Nordisk or visiting novonordisk-us.com.

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

SoloSTAR® is a registered trademark of sanofi-aventis U.S. L.L.C

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 novonordisk.com.

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