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

Main Category: Diabetes
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 06 May 2008 - 0:00 PST

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A new study examining the dose accuracy of the SoloSTAR(R) disposable insulin pen, prefilled with Lantus(R) (insulin glargine [rDNA origin] injection) or Apidra(R) (insulin glulisine [rDNA origin] injection), found the pens accurately delivered all insulin doses within standard limits defined by the International Organization for Standardization (ISO). Lantus(R) SoloSTAR(R) was approved by the U.S. Food and Drug Administration (FDA) on April 25, 2007. Apidra(R) for use in the SoloSTAR(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 Society for Diabetes (DDG) in Munich, Germany, examined the accuracy of both pens at multiple target dosages to determine the proportion of doses that fell within ISO ranges.

"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 the findings of this study, we concluded that the SoloSTAR(R) pen is an accurate insulin delivery option for people with diabetes."

The study participants, a random sample of 60 hospital inpatients with type 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 the insulin pens before and after injection. The order of the dosages was randomized. All doses (100%) were within the limits prescribed by the ISO standard (mean doses were only 0.9% to 1.3% below targets for Lantus(R), and 0.4% to 1.1% below targets for Apidra(R)), and the data set was within the ISO-defined 97.5% confidence intervals at each dose.

About Diabetes

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

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