Dear Doctor Column, February 13, 2006

Inhaled Insulin Can Help Reduce Daily Injections

Question:

I have type 1 diabetes. Does the new inhaled form of insulin work as well as injections, and if so, can I replace my daily shots with the inhaled form?

Answer:

The US Food and Drug Administration (FDA) recently approved Exubera — the first inhaled form of insulin — for treatment of adults with type 1 or type 2 diabetes. Exubera will be available in pharmacies by June or July 2006, according to its manufacturer. The drug comes in a dry powder form that is placed into a handheld inhaler. The inhaler converts the powder into a cloud that is easily inhaled into the lungs and passes rapidly into the bloodstream. The device is larger than inhalers used by people with asthma, and FDA expressed some concerns about its bulkiness. It weighs about 4 ounces, and when folded, is about the size of a standard flashlight.

Of the 21 million Americans with diabetes, about 5 million need daily insulin injections to regulate their blood sugar, the American Diabetes Association (ADA) reports. The vast majority have type 2 diabetes, a condition in which the body does not make enough insulin or cannot effectively use it to control blood sugar levels. People with type 1 diabetes produce little or no insulin and must take supplemental insulin.

Insulin provides good blood sugar control, but many people have a hard time keeping up with the daily routine of repeated finger pricks to measure blood sugar and multiple injections of insulin. About 15% of diagnosed diabetics don’t take their medications as they should, ADA says. Tightly controlling blood sugar levels allows people with diabetes to avoid serious complications of the disease, such as blindness, kidney failure, nerve damage, and heart disease.

Inhaled insulin is an attractive alternative to shots, but the drug cannot replace all injections and is not appropriate for everyone. Exubera is a rapid-acting insulin, and individuals with both type 1 and type 2 diabetes can potentially substitute it for some mealtime injections, which control spikes in blood sugar that occur in response to food. The drug cannot replace injections of longer-acting insulin that people with type 1 diabetes, who always need some level of insulin in their blood, typically take in the morning or evenings.

Individuals with type 2 diabetes can often control their blood sugar with diet and exercise alone. Those who have problems managing their blood sugar after meals may benefit from Exubera or an injectable fast-acting insulin.

People using Exubera will still need to measure blood sugar levels and many will use the inhaled drug in combination with oral medications, injected insulin, or both. Your doctor can explain how inhaled insulin might fit into your diabetes management plan.

Researchers studied Exubera’s safety and effectiveness in 2500 adults with type 1 and type 2 diabetes. The trials found the short-acting inhaled insulin effectively manages blood sugar levels, although ADA notes injectable insulin provides more precise dosing. Study data also found that fewer than 30% of people with type 1 diabetes achieved recommended levels of blood sugar control after 6 months of treatment with Exubera.

Safety concerns surrounding inhaled insulin have focused on its potential to cause lung damage, and people who smoke or who quit smoking less than 6 months ago should not use Exubera. The drug also is not recommended for individuals with lung diseases, including asthma, bronchitis, or emphysema. FDA has called for additional studies to assess long-term safety and further examine risks in people with lung disease. The drug is not recommended for women who are pregnant and children younger than 18 years.

For more information about diabetes, visit ADA’s Web site at www.diabetes.org.