Open 24 Hours – Once-Per-Day Basal Insulin Submitted to FDA

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By: Sharon Kellaher

One shot per day of long-acting insulin may be all that you need in the future, if the U.S. Food and Drug Administration (FDA) approves Hoechst’s insulin glargine, a 24-hour basal insulin.

Hoechst submitted a new drug application in the United States and Europe during May. It could take as long as one year before the FDA makes a ruling.

“Patients loved it,” says John Buse, MD, PhD, CDE, of the people who participated in the clinical trials he conducted for Hoechst. Buse directs the University of North Carolina’s Diabetes Center.

Most of the people who participated in the clinical trials were not doing well on NPH or Ultralente, but, according to Buse, insulin glargine improved their control.

“They’re upset that they cannot continue on it,” says Buse. Because the clinical trials have ended, the participants must now wait for FDA approval to use insulin glargine again.

More Stable

Buse believes that this 24-hour insulin is more stable in its absorption, but cannot precisely explain why.

“With other long-acting insulins, it is a multi-step process to get absorbed in the body,” reports 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.”

Insulin glargine, however, dissolves in a different way that doesn’t turn it into crystal. “Insulin glargine 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 insulin glargine 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.

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