The drug, called NN1952, will be tested in 150 volunteers over more than a year. The company will examine how the drug is metabolized in patients with Type 1 or Type 2 diabetes, and in healthy people.
Some doctors say they’ll need to see the data before they can get excited about oral insulin. One issue with past attempts was that the pills were affected by food in unexpected ways, says Howard Wolpert, a senior physician at the Joslin Diabetes Center in Boston. “The data from the tests would look okay, and then you’d give it with meals and find the absorption was affected,” says Wolpert, who is not participating in the Novo trials. “Getting the insulin absorption to match the carbohydrate absorption creates a confounding variable.”
Novo’s phase 1 program will include food-interaction studies, Thomsen says. Still, the extent to which oral insulin might be able to replace injections is not yet known: The company will test the drug at various doses, with or without meals, and compare it with both injections and placebos. Thomsen believes oral insulin may prove to be most appealing to Type 2 diabetics, who aren’t dependent on insulin injections because their pancreases are still able to make the protein. Should those patients need an extra boost, however, they may prefer to get it from something other than a needle. “There’s a difference between taking a tablet a day and an injection a day,” he says.
Other companies are experimenting with different delivery methods for insulin. Generex Biotechnology of Worcester, MA, is in late-stage testing of an insulin spray that’s absorbed through the back of the throat. And MannKind of Valencia, CA, is awaiting a verdict from the U.S. Food and Drug Administration on its insulin inhaler.
Sanjoy Dutta, director of the insulin initiative at the Juvenile Diabetes Research Foundation, says the onus will be on all of these companies to prove that the insulin drugs they deliver mark an improvement over what diabetics are injecting today. “We are tremendously interested in insulins that are safer, more efficacious, faster-acting, and compatible with other medications,” Dutta says. “If they come orally, that would be icing on the cake.”