Panel OKs New Insulin-Spurring Drug
Nov. 19, 1997
BETHESDA, Md. (AP) _ Diabetics may soon get a new medicine that promises to help their bodies produce insulin only when they need it, at mealtime.
Scientific advisers to the Food and Drug Administration recommended Wednesday that Novo Nordisk's repaglinide be approved to treat Type II diabetes.
But the doctors cautioned they weren't sure how to prescribe the drug _ and asked if diabetics really would opt to take a drug three times a day, 15 minutes before every meal, when older medicines work with just one tablet a day.
``You need insulin when you eat,'' responded company scientist Dr. Peter Damsbo. ``No meal, no tablet.''
But Novo Nordisk never proved that taking medicine only with meals actually improved diabetes care, panel chairman Dr. Robert Sherwin of Yale University said after the 8-1 vote.
``All of us had some mixed emotions'' about backing repaglinide, he said, noting that scientists don't understand how it works or even know the best dose. ``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 to survive need lifelong, daily shots of the hormone, which converts blood sugar into energy.
The vast majority of 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.
A healthy body quickly produces insulin after a meal to promptly digest blood sugar. Type II diabetics take longer to produce that insulin, and it takes longer for it to work.
Once-a-day pills increase insulin production daylong _ not just when blood sugar skyrockets after meals, but even when blood sugar naturally dips low, as in patients who don't have a snack before going to bed. The theory is that a drug that worked only at mealtime might decrease the risk of serious hypoglycemia _ when patients' blood sugar actually drops so low that they could pass out, even enter a coma.
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.
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.''
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.
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.