Editor's Note: The FDA approved the inhaled insulin drug Exubera in 2006, but in October 2007 the drug company Pfizer said it was halting sales of the drug because of financial reasons.
March 9, 2005 -- Inhaled insulin appeals to people with type 2 diabetes, an international study shows.
Pharmaceutical giants Pfizer and Aventis funded the study. The firms seek FDA approval for their inhaled insulin product, Exubera. Pending safety tests, no inhaled insulin product is currently on the market. Pfizer is a WebMD sponsor.
But the findings, from a respected international team of diabetes researchers, show that inhaled insulin will play at least one major role in diabetes care. Patients who won't take insulin shots -- even when their doctors tell them to do so -- would take the inhaled form of the hormone, says researcher Nick Freemantle, PhD, of the University of Birmingham, U.K.
"Doctors often talk of the difficulty of having patients take what is often the inevitable next step -- taking insulin at meal time," Freemantle tells WebMD. "This study suggests that making insulin available in an inhaled form may help break down those barriers. When people need insulin to get their diabetes under control, it becomes a less dramatic, less painful step."
Freemantle's team enrolled 779 adults with type 2 diabetes. Despite treatment, blood tests showed that their diabetes was poorly controlled. Researchers offered half the patients standard treatment, including insulin injection. The other patients were offered the same thing, but were also asked whether, if it became available, they would take inhaled insulin.
The bottom line: The option of inhaled insulin made it three times more likely that a patient would choose insulin therapy. Among those offered inhaled insulin, 43.2% chose insulin treatment. Among those offered only insulin injections, only 15.5% took the insulin option.
The findings appear in the February issue of Diabetes Care.
The study findings don't surprise Eugene Barrett, MD, PhD, immediate past president of the American Diabetes Association, and director of the Diabetes Center at the University of Virginia Health System. Barrett has consulted for Pfizer but has not done any such work for more than a year.
"Inhaled insulin would be more acceptable for some patients," Barrett tells WebMD. "There is an issue -- more for some patients than others -- with following a doctor's advice to take insulin. For some patients, an inhaled insulin preparation would be useful because they are afraid or apprehensive about giving themselves injections. Some people with type 2 diabetes delay or procrastinate -- they just won't go on insulin. But most times, if you get them over that, they recognize it is not as big a deal as they thought."
Freemantle hears this often from the diabetes doctors he works with.
"Oh, the avoidance techniques patients use when their doctors suggest a switch from oral drugs to insulin," he says. They say, 'I'll improve my diet,' or, 'I am going through a difficult time right now,' or 'I will get better.' It leaves a doctor with a sense of powerlessness. If doctors can offer patients something different, like inhaled insulin, it gives them a bit of new ammunition to tackle this problem."
Barrett notes that inhaled insulin won't just be used by those starting insulin therapy. It might also be used by people with type 1 or type 2 diabetes already on injection insulin. When in a social situation at mealtime, a person could use an inhaler instead of a needle to get the insulin dose they need for blood-sugar control. Or, the inhaler could simply offer a break to people taking three to five insulin shots a day.
"I've asked those people, 'Given that you've been taking insulin injections for 10-15 years, if given the chance to inhale some of your insulin doses, would you?' Most say, 'Great, sometimes I'd rather take the inhalation,'" Barrett says.
And Barrett notes that inhalation insulin might be more acceptable than insulin shots for children with type 1 diabetes.
Safety of Inhalation Insulin Still Not Proved
Nobody will be taking inhalation insulin if it isn't safe. So far, there haven't been any major safety problems with inhaled insulin. But insulin isn't a short-term treatment. Patients take it for the rest of their lives. That is why the FDA is taking a hard look at safety data on Exubera.
Meanwhile, Freemantle's team is continuing their study. Instead of merely asking patients whether they would take inhaled insulin, they're now actually offering them the chance to take it. It remains to be seen whether patients really do what they say they will do.