New Long-Acting Insulin Approved by the FDA Glargine (Lantus) Provides Concentration Over 24-hour Period


By: dhtest

On April 24, Aventis Pharmaceuticals of Parsippany, New Jersey,announced that the U.S. Food and Drug Administration has approvedthe 24-hour basal insulin glargine (now called Lantus) for thetreatment of type 1 and type 2 diabetes. The company plans tolaunch 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-hourduration 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 DiabetesCenter, said people in clinical trials loved Lantus. Buse saysmost of the people who participated in the clinical trials werenot doing well on NPH or Ultralente. Lantus, however, improvedtheir control.

"With other long-acting insulins, it is a multi-stepprocess to get absorbed in the body," said Buse. "Uponinjection, these insulins’ crystals first have to break up, thenthe insulin crosses into the bloodstream. Each of these stepsis affected by a variety of causes."

Lantus dissolves in a different way. It never turns it intocrystal.

"[Lantus] precipitates inside the body," accordingto Buse. "It is absorbed more regularly than crystals."

Buse claims that it does not make a difference whether youtake your single Lantus shot in the morning or evening. It hasa "slight peak," he says, about 12 to 14 hours afterinjection, so that should be taken into account.

Hypoglycemia Most Common Adverse Effect

Aventis says hypoglycemia is the most common adverse effect ofinsulins, including Lantus. In clinical studies of adult patients,there was a higher incidence of injection site pain (2.7 percentLantus versus 0.7 percent NPH). The reports of pain at the injectionsite were usually mild and did not result in discontinuationof therapy.

As with all insulins, the timing of hypoglycemia may differamong various insulin formulations. Glucose monitoring is recommendedfor all patients with diabetes.

To receive prescribing information, call (800)552-3656, orvisit the Aventis Web site at



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