Pfizer reports long-term data from phase 3 trials support long-term efficacy, safety of Exubera for diabetes

New York, June 12 - Pfizer Inc. said results from two ongoing studies of Exubera (insulin human) Inhalation Powder in adults with type 1 or type 2 diabetes showed sustained blood sugar control over a two-year period.

The patients gained about half as much weight as those taking injected insulin.

"These findings are important because they confirm that people who switched from rapid-acting injectable insulin to Exubera experienced no loss of blood sugar control," Dr. Julio Rosenstock, lead investigator from the Dallas Diabetes and Endocrine Center at Medical City and also a clinical professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said in a news release.

"This long-term study also builds on earlier studies of type 2 patients showing that Exubera can significantly improve blood sugar control when used alone or added to diabetes pills in patients not controlled on two diabetes pills," he said. "Overall, Exubera is a valuable new option that could lead to earlier acceptance of insulin among people with type 2 diabetes, and potentially reduce the debilitating and costly complications associated with the disease."

The phase 3 data was presented at the 66th annual scientific sessions of the American Diabetes Association.

For type 2 diabetes, 635 adults who had stable injected insulin therapy at baseline were randomized to receive either Exubera or continued injected insulin therapy.

Blood sugar levels (A1c) at baseline were 7.7% (Exubera) and 7.8% (injected insulin). After two years of treatment, patients in both groups had similar improvement or maintained their blood sugar levels (A1C levels of 7.3%).

Patients with Exubera also achieved slightly better fasting blood sugar levels.

Weight gain in patients taking Exubera was 1.7 kg compared to 3 kg 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.

For type 1 diabetes, the research covered 582 adults.

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

Weight gain in patients taking Exubera was 0.8 kg compared to 2 kg 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.

Pfizer is a pharmaceutical company based in New York.

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