Patients with Type 2 diabetes who had failed to meet recommended blood glucose levels with combination oral therapy achieved better glycemic control with Exubera (inhaled insulin) than patients who received only oral agents, according to data presented at the annual meeting of the American Diabetes Association.

The three-month Phase III study involved 309 patients who had been diagnosed with Type 2 diabetes. The study examined whether Exubera, an inhalable rapid-acting dry powder insulin, could provide better glycemic control when taken alone or in combination with oral agents, compared with patients taking only oral agents. Exubera was administered before meals.

Patients in the study taking either Exubera alone or Exubera plus oral agents experienced a significant decrease in the hemoglobin (HbA1c), which reflects average blood glucose levels over a period of several months. Patients taking oral agents alone experienced no change in HBA1c levels over the three-month period.

"Currently many patients with type 2 diabetes fail to reach target glucose levels on oral agents, which will eventually lead to the need for insulin therapy," said Dr. Julio Rosenstock, Dallas Diabetes and Endocrine Center and Clinical Professor of Medicine at the University of Texas, Southwestern Medical Center. "This study shows that Exubera has the potential to help patients with type 2 diabetes by providing an effective and highly acceptable treatment option."

Patients taking Exubera showed also significantly greater decreases in both fasting plasma glucose concentrations (a measurement taken before breakfast) and two-hour post-prandial glucose levels (a measurement taken after a meal) compared to patients who took only oral agents. In Addition, target HbA1c levels of <8% and <7% (recommended ADA action and goal levels, respectively) were achieved by significantly more Exubera patients.

Patients preferred using Exubera and reported significant improvements in overall treatment satisfaction. Patients also showed more favorable improvements in symptoms and cognitive function, according to a Diabetes Quality of Life and Treatment Satisfaction questionnaire.

The majority of adverse events in the study were mild to moderate in all treatment groups. Hypoglycemia rates (abnormally low levels of blood sugar) and weight gain, both common side effects of insulin therapy, were higher in those patients treated with Exubera. Pulmonary function remained stable in patients using Exubera and pulmonary function tests showed no significant differences between groups.

There are approximately 17 million people in the United States with diabetes with 90-95% of all cases accounting for type 2 diabetes. Type 2 diabetes is typically associated with older age, obesity, family history and race/ethnicity and is increasingly being diagnosed in children and adolescents. When left uncontrolled, diabetes can lead to kidney failure, blindness, amputations and premature death. In addition, people with diabetes are two to four times more likely to have a heart attack or stroke. Research studies in the United States and abroad have found that improved glycemic control benefits people with either type 1 or Type 2 diabetes by reducing, and even preventing, diabetes related complications.

Exubera is being developed in patients with type 1 and type 2 diabetes through a collaboration between Pfizer Inc and Aventis Pharma. The two companies have entered into a global agreement to co-develop, co-promote (where permitted by local law) and co-manufacture inhaled insulin. Pfizer is also in collaboration with Inhale Therapeutic Systems, developers of the inhalation device and formulation process.