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FDA panel backs new insulin-spurring drug

November 20, 1997

BETHESDA, Md. (AP) _ Certain diabetics may soon get the option of taking insulin-spurring medicine with meals _ the only time they need it. But government scientists cautioned that there’s no proof this new type of treatment is better than older drugs.

An advisory panel recommended Wednesday that the Food and Drug Administration approve Novo Nordisk’s replaginide to treat Type II diabetes.

But the advisers said they also wanted to see more research on how the drug works and what’s the best dose _ and asked whether diabetics would choose to take a drug three times a day, 15 minutes before every meal, when older medicines work with just one dose.

``All of us had some mixed emotions″ about backing repaglinide, panel chairman Dr. Robert Sherwin of Yale University said after the 8-1 vote. ``The drug was comparable to other drugs already on the market. Superiority wasn’t clearly demonstrated.″

The FDA is not bound by advisory committee decisions, but typically follows them. Because repaglinide, to be sold under the brand name Prandin, is the first in a new class of diabetes drugs, the government has promised a quick decision.

About 18 million Americans have diabetes. Type I diabetes typically strikes children, who cannot produce insulin and need lifelong, daily shots of the hormone, which converts blood sugar into energy.

Most diabetics _ 16 million _ have Type II, also known as the noninsulin-dependent type that usually hits in adulthood. The body’s natural insulin gradually loses its ability to work, letting blood sugar rise. Unchecked, that can cause kidney damage, blindness, heart disease and other complications.

These Type II diabetics are the ones repaglinide is supposed to help. They already can choose other once-a-day pills to boost insulin production and decrease blood sugar.

But Novo Nordisk argued that diabetics only need to produce more insulin when they eat. It said that made repaglinide a better option than longer-acting drugs, particularly for patients who skip meals or go to bed without a snack _ meaning the medicine they took hours ago is working when their blood sugar doesn’t really need adjusting. Sometimes that spurs hypoglycemia, dangerous plummets of blood sugar.

``You need insulin when you eat,″ said company scientist Dr. Peter Damsbo. ``No meal, no tablet.″

In Novo Nordisk’s studies, repaglinide patients had a 60-milligram drop in their overall blood sugar levels, similar to other diabetes drugs, said company scientist Dr. Martin Edwards. Patients had a roughly 2 percent drop in glycosolated hemoglobin, a measure of how high blood sugar affects diabetics’ hemoglobin over time.

In safety studies of 1,200 patients, no one suffered hypoglycemia serious enough to require medical attention. About 1.5 percent of patients dropped out the study citing mild to moderate hypoglycemia, compared with about 2.5 percent of control patients who quit taking older diabetes medicines for the same reason.

Diabetics who tend to skip meals might benefit from repaglinide, FDA adviser Sherwin said.

But ``did they really prove it mattered? Not really,″ he said. ``Most patients would prefer to be on once-a-day medication.″

Repaglinide patients suffered slightly more cardiovascular side effects _ including five patients who died of heart attacks compared with just one heart attack death among control patients taking other diabetes medicines. But the FDA advisers split on whether the findings were chance or a serious risk, and Novo Nordisk wants to study the question in depth while it sells the drug.

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