New Long-Acting Insulin Approved by the FDA Glargine (Lantus) Provides Concentration Over 24-hour Period
On April 24, Aventis Pharmaceuticals of Parsippany, New Jersey, announced that the U.S. Food and Drug Administration has approved the 24-hour basal insulin glargine (now called Lantus) for the treatment of type 1 and type 2 diabetes. The company plans to launch the drug in September. Because it lasts for 24 hours, Lantus can be taken once per day. Other insulin products, according to Aventis, only have a 14.5-hour duration and must be administered at least two times per day.
Lantus is also indicated for daily use in kids with type 1 diabetes.
Patients Loved it
In the July 1999 issue of Diabetes Health, John Buse, MD, PhD, CDE, director of the University of North Carolina's Diabetes Center, said people in clinical trials loved Lantus. Buse says most of the people who participated in the clinical trials were not doing well on NPH or Ultralente. Lantus, however, improved their control.
"With other long-acting insulins, it is a multi-step process to get absorbed in the body," said Buse. "Upon injection, these insulins' crystals first have to break up, then the insulin crosses into the bloodstream. Each of these steps is affected by a variety of causes."
Lantus dissolves in a different way. It never turns it into crystal.
"[Lantus] precipitates inside the body," according to Buse. "It is absorbed more regularly than crystals."
Buse claims that it does not make a difference whether you take your single Lantus shot in the morning or evening. It has a "slight peak," he says, about 12 to 14 hours after injection, so that should be taken into account.
Hypoglycemia Most Common Adverse Effect
Aventis says hypoglycemia is the most common adverse effect of insulins, including Lantus. In clinical studies of adult patients, there was a higher incidence of injection site pain (2.7 percent Lantus versus 0.7 percent NPH). The reports of pain at the injection site were usually mild and did not result in discontinuation of therapy.
As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes.
To receive prescribing information, call (800)552-3656, or visit the Aventis Web site at www.aventispharma-us.com.Click Here To View Or Post Comments