Aventis announced that its basal insulin, Lantus, has been approved by the U.S. Food and Drug Administration for flexible administration at any time of day.

Lantus is the first and only basal insulin analog that provides 24-hour glucose lowering activity with just one injection. This new approval in the dosing schedule for Lantus from once daily at bedtime to flexible daily dosing means patients using Lantus may have more options in managing their diabetes. The long lasting basal insulin should be administered once daily at any time, but at the same time each day.

"Uncontrolled diabetes is reaching epidemic levels putting millions of people around the world at risk for devastating complications including blindness, heart disease, amputation and kidney damage. It is through medical advances that offer new treatment and dosing options, that patients with diabetes will gain better control of their disease," says Francois Nader, Senior Vice President, Medical Affairs, Aventis Pharmaceuticals, North America. "Aventis is committed to meeting the needs of patients with diabetes by continuing our clinical development program for Lantus and other promising new products in our pipeline."

Basal insulin therapy can effectively help patients with diabetes achieve tight blood sugar control, defined by the American Diabetes Association (ADA) as an A1C<7.0 percent and by the International Diabetes Federation (IDF) as an A1C<6.5 percent; however, less than half of the more than 11 million Americans diagnosed with diabetes are meeting these blood sugar goals. Worldwide, less than 20 percent of the people with diabetes have good metabolic control.

Lantus demonstrates a slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours. It is unique in that it has no pronounced peak. Lantus also has a consistent delivery of insulin and similar absorption and consistency of action regardless of injection site.