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Apidra (insulin glulisine [rDNA origin] injection) Now Available in the U.S. for Hyperglycemia in Adults with Type 2 and Type 1 Diabetes

New prandial insulin with the OptiClik(R) delivery system can work with longer-acting insulins, such as basal insulin Lantus, providing a complementary approach to glucose control

BRIDGEWATER, N.J. -- February 28, 2006 -- Sanofi-aventis U.S. 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 patient's 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.

Important Safety Information
Apidra is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Apidra or one of its excipients.

Apidra differs from regular human insulin by its rapid onset of action and shorter duration of action. When used as a mealtime insulin, the dose of Apidra should be given within 15 minutes before or immediately after a meal.

Because of the short duration of action of Apidra, patients with diabetes also require a longer-acting insulin or insulin infusion pump therapy to maintain adequate glucose control.

Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength may result in the need for a change in dose. Concomitant oral antidiabetic treatment may need to be adjusted.

As with all insulin preparations, the time course of Apidra action may vary in different individuals or at different times in the same individual and is dependent on site of injection, blood supply, temperature, and physical activity.

Glucose monitoring is recommended for all patients with diabetes.

Hypoglycemia is the most common adverse effect of insulin therapy, including Apidra. The timing of hypoglycemia may differ among various insulin formulations.

Adverse events commonly associated with human insulin therapy include hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash.


About Lantus (insulin glargine [rDNA origin] injection)
Lantus is indicated for once-daily subcutaneous administration, at the same time each day, for the treatment of adult and pediatric patients (6 years and older) with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

LANTUS MUST NOT BE DILUTED OR MIXED WITH ANY OTHER INSULIN OR SOLUTION. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner.

Lantus is contraindicated in patients hypersensitive to insulin glargine or the excipients.

Hypoglycemia is the most common adverse effect of insulin, including Lantus. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes. Any change of insulin type and/or regimen should be made cautiously and only under medical supervision. Concomitant oral antidiabetes treatment may need to be adjusted.

Other adverse events commonly associated with Lantus include the following: lipodystrophy, skin reactions (such as injection-site reaction, pruritus, rash), and allergic reactions.


SOURCE: sanofi-aventis

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