Pressmeddelande -
Apidra ® A New Rapid-Acting Insulin Analog is Now Available in the United States for Hyperglycemia in Adults with Type 2 and Type 1 Diabetes
New prandial insulin with the OptiClik® delivery system
can work with longer-acting insulins, such as basal insulin Lantus®, providing a complementary approach to glucose control
Sanofi-aventis announced today that Apidra® (insulin glulisine [rDNA origin] injection), a new prandial or mealtime insulin analog, is now available by prescription in the
United States for the control of hyperglycemia in adult patients with type 1 and type 2 diabetes.
Apidra® should normally be used in regimens that include a longer-acting insulin or basal insulin
analog such as Lantus® (insulin glargine [rDNA origin] injection).
Sanofi-aventis has also announced that Apidra® cartridges are now available for use with the insulin
injection pen OptiClik®. OptiClik® is a reusable pen device with advanced features that help to ensure
that diabetes patients get the correct dose of insulin every time. OptiClik® is also currently approved
for use with Lantus®, the only once-daily, 24- hour insulin with no pronounced peak.
Apidra® has a more rapid onset of action and a shorter duration of action than regular human insulin,
and offers people with diabetes greater mealtime dosing flexibility versus regular human insulin
because they can take Apidra® either before or after a meal (within 15 minutes before or within 20
minutes after starting a meal).
Apidra® is also flexible for use in adults with diabetes whose BMIs
range from lean to obese. Increased adiposity and higher BMI can affect rapid absorption of insulin,
making prandial control a challenge especially for overweight patients.
Controlling mealtime blood sugar spikes is a crucial part of managing diabetes, said Richard M.
Bergenstal, MD, Executive Director of the International Diabetes Center at Park Nicollet,
Minneapolis, MN.
Apidra® is a welcome addition to the armamentarium of all healthcare
professionals who treat adults with diabetes.
About Diabetes
Diabetes is a chronic, widespread condition in which the body does not produce, or properly use
insulin, the hormone needed to convert glucose (sugar) into energy. People with diabetes may need
different types of insulin at certain times of the day and at different stages of the progression of their
diabetes to help them manage their blood glucose levels. Optimal treatment of hyperglycemia closely
mimics the patients physiology.
Controlling blood sugar levels is an important key to fighting the current diabetes epidemic. In the
U.S., more than 20 million people have diabetes, including an estimated 6 million who remain
undiagnosed. At the same time, approximately 60 percent of those diagnosed are not in control.
According to the American Diabetes Association, the optimal control goal for people with diabetes in
general is an A1C level of less than 7 percent. The A1C test measures blood glucose levels over a
two- to three-month period. The United Kingdom Prospective Diabetes Study (UKPDS) showed that
using insulin in the treatment of type 2 diabetes can when combined with oral medications, diet, and
exercise help people with diabetes achieve and maintain tight glucose control, helping to reduce their
risk of blindness, amputation, kidney failure, stroke and heart attack.
About APIDRA® (insulin glulisine [rDNA origin] injection)
Apidra® is indicated for the treatment of adult patients with diabetes mellitus for the control of
hyperglycemia. Apidra® has a more rapid onset of action and a shorter duration of action than regular
human insulin. Apidra® should normally be used in regimens that include a longer-acting insulin or
basal insulin analog.
About sanofi-aventis
Sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe.
Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven
major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous
system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).
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with the SEC and the AMF made by sanofi-aventis, including those listed under Risk Factors and
Cautionary Statement Regarding Forward -Looking Statements in sanofi-aventis annual report on
Form 20-F for the year ended December 31, 2004. Other than as required by applicable law, sanofiaventis
does not undertake any obligation to update or revise any forward-looking information or
statements. The sanofi-aventis Group conducts its business in the United States through its subsidiaries
Sanofi-Synthélabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.