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Exubera inhalant option shows promise for type 1 diabetes patients

CHICAGO, ILL. -- Exubera (inhaled insulin) may provide a promising treatment option for patients with Type 1 diabetes, according to data presented at the annual meeting of the American Association of Clinical Endocrinologists.

A six-month, Phase III study involved 335 patients with Type 1 diabetes between the ages of 12 and 65. The study was designed to evaluate whether an insulin regimen that included Exubera, an inhalable, rapid-acting dry powder insulin, taken before meals, plus a single injection of long-acting insulin at bedtime, could provide glycemic control similar to two to three insulin injections per day.

In the study, the glycated hemoglobin (HbA1c), which reflects average blood glucose levels over an eight to 12 week period, decreased similarly for patients taking Exubera and one injection compared to patients who received two to three insulin injections per day. The percentage of patients achieving an HbA1c of less than seven percent or eight percent -- a recommended treatment goal for patients with diabetes -- was also similar in both groups.

In addition, patients using Exubera showed 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 insulin injections. Patients in both the Exubera and multiple injection groups worked with their physicians during the study to adjust their insulin dose to optimize blood glucose control.

Overall, patients in the study preferred using Exubera and experienced fewer hypoglycemic events (or abnormally low levels of blood sugar) compared to patients taking only insulin injections. Additionally, patients taking Exubera reported significant improvements in overall treatment satisfaction and quality of life and showed more favorable improvements in symptoms such as depression, well-being and cognitive function, according to a Diabetes Quality of Life and Treatment Satisfaction Questionnaire. Patients taking Exubera also experienced less weight gain.

"The results of this study suggest that inhaled insulin in combination with one injection of long-acting insulin can be a new, effective and non-invasive form of insulin therapy in patients with type 1 diabetes," said Dr. Teresa Quattrin, lead study investigator and associate professor at the Children's Hospital of Buffalo.

Posted: May 2002