Results from two ongoing studies showed adults with type 1 or type 2 diabetes treated with Exubera, a rapid-acting, dry powder human Insulin, experienced sustained blood glucose control over a two-year period and gained about half as much weight as those taking injected Insulin.


Type 2 diabetes study

A total of 635 adults with type 2 diabetes who had stable injected Insulin therapy at baseline were randomized to receive either Exubera or continued injected insulin therapy.

Blood glucose levels ( A1c ) at baseline were 7.7 percent ( Exubera ) and 7.8 percent ( injected insulin ).
After two years of treatment, patients in both groups had similar improvement or maintained their blood glucose levels ( A1C levels of 7.3 percent ).
Patients with Exubera also achieved slightly better fasting blood glucose levels.

Weight gain in patients taking Exubera was 1.7 kg ( 3.7 pounds ) compared to 3 kg ( 6.6 pounds ) in patients taking injected Insulin. Exubera was well-tolerated and this study confirmed that mean decreases in lung function relative to comparator treatments were small, occurred early, did not progress and showed resolution shortly after discontinuation of therapy.

Adverse events were similar in both groups with exception of cough, which was more frequent in the Exubera group.
The cough was defined as mild, occurring shortly after dosing and rarely resulted in discontinued treatment.


Type 1 diabetes study

A total of 582 adults with type 1 diabetes who had stable injected Insulin therapy at baseline were randomized to receive either Exubera or continued injected insulin therapy.

Baseline blood glucose levels ( A1c ) were 7.4 percent ( Exubera ) and 7.5 percent ( injected Insulin ). After two years of treatment, patients improved or maintained their blood glucose control.

Weight gain in patients taking Exubera was 0.8 kg ( 1.7 pounds ) compared to 2 kg ( 4.4 pounds ) in patients taking injected Insulin.

Exubera was well-tolerated, with comparable lung function changes, and this study confirmed that mean decreases in lung function relative to comparator treatments were small, occurred early and did not progress.

Adverse events were similar in both groups with the exception of cough, which was more frequent in the Exubera group. The cough was defined as mild, occurring shortly after dosing and rarely resulted in discontinued treatment.


Exubera is the first inhaled form of insulin and the first insulin option in the U.S., European Union in more than 80 years that does not need to be administered by injection.

It is a rapid-acting Insulin that is inhaled through the mouth prior to eating, using the handheld Exubera Inhaler. The unique Exubera Inhaler produces a standing cloud of Insulin powder, which is designed to pass rapidly into the bloodstream to regulate the body’s blood glucose levels.

In the U.S., Exubera is approved for the treatment of adults with type 1 or type 2 diabetes for the control of high blood glucose levels. In patients with type 2 diabetes, Exubera can be used alone or in combination with diabetes pills or longer-acting Insulin.
In patients with type 1 diabetes, Exubera should be used in combination with a longer-acting Insulin.

In the European Union, Exubera is approved for the treatment of adult patients with type 2 diabetes who require Insulin therapy and are not adequately controlled with diabetes pills. In patients with type 1 diabetes, Exubera should be used in combination with long or intermediate acting insulin.

Patients should not take Exubera if they have poorly controlled or unstable lung disease, or if they smoke or have stopped smoking less than six months prior to starting Exubera treatment. If a patient starts smoking or resumes smoking, he or she must stop using Exubera and see a health care provider about a different treatment.

Before starting treatment with Exubera, a health care provider will carry out a simple test to check lung function. This will help to find out if Exubera is the right treatment for individual patients. Once a patient starts treatment, it is recommended that a health care provider check lung function again at six months and yearly thereafter.

As with all forms of Insulin, a possible side effect of Exubera is hypoglycemia.

Some patients have reported a mild cough while taking Exubera, which occurred within seconds to minutes after Exubera inhalation. Coughing occurred less frequently as patients continued to use Exubera.

In clinical trials, mean treatment group differences between Exubera and comparator showed that Exubera was associated with small, non-progressive declines in lung function relative to comparator treatments.

Source: Pfizer, 2006


XagenaMedicine2006