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New Study Confirms Dose-Accuracy of SoloSTAR(R) Prefilled Insulin Pen

Tuesday, May 6, 2008 General News
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BRIDGEWATER, N.J., May 5 A new study examiningthe dose accuracy of the SoloSTAR(R) disposable insulin pen, prefilled withLantus(R) (insulin glargine [rDNA origin] injection) or Apidra(R) (insulinglulisine [rDNA origin] injection), found the pens accurately delivered allinsulin doses within standard limits defined by the International Organizationfor Standardization (ISO). Lantus(R) SoloSTAR(R) was approved by the U.S. Foodand Drug Administration (FDA) on April 25, 2007. Apidra(R) for use in theSoloSTAR(R) prefilled disposable pen is currently under review at the FDA.The study, presented on May 2, 2008 at the 43rd Congress of the German Societyfor Diabetes (DDG) in Munich, Germany, examined the accuracy of both pens atmultiple target dosages to determine the proportion of doses that fell withinISO ranges.
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"For people with diabetes who use an insulin pen to deliver their insulin,dose accuracy is essential for their treatment," stated Norbert Hermanns,Ph.D., director of the Research Institute of the Diabetes Academy Mergentheim,Bad Mergentheim, Germany, and lead investigator in the study. "Based on thefindings of this study, we concluded that the SoloSTAR(R) pen is an accurateinsulin delivery option for people with diabetes."
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The study participants, a random sample of 60 hospital inpatients withtype 1 and type 2 diabetes, were trained on correct use of the SoloSTAR(R)pen. Participants were then asked to inject three target doses with Lantus(R)into an insulin-sponge, in doses of 10 (low), 40 (medium) and 80 (high) units,and three doses of Apidra(R) in doses of 5 (low), 15 (medium) and 30 (high)units. The quantity of insulin delivered was calculated by the weight of theinsulin pens before and after injection. The order of the dosages wasrandomized. All doses (100%) were within the limits prescribed by the ISOstandard (mean doses were only 0.9% to 1.3% below targets for Lantus(R), and0.4% to 1.1% below targets for Apidra(R)), and the data set was within theISO-defined 97.5% confidence intervals at each dose.

About Diabetes

Diabetes is a chronic, widespread condition in which the body does notproduce or properly use insulin, the hormone needed to transport glucose(sugar) from the blood into the cells of the body for energy. More than 230million people worldwide are living with the disease and this number isexpected to rise to a staggering 350 million within 20 years. It is estimatedthat more than 20 million Americans have diabetes, including an estimated 6.2million who remain undiagnosed. At the same time, approximately half of thosediagnosed are not achieving the general blood sugar control standard of A1C <7percent recommended by the American Diabetes Association (ADA). The A1C testmeasures average blood glucose levels over a two- to three-month period.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers,develops and distributes therapeutic solutions to improve the lives ofeveryone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York(NYSE: SNY).U.S. Contacts: Carrie Melia [email protected] 908-981-6486 US.GLA.08.05.001

SOURCE sanofi-aventis
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