Wednesday, November 2, 2005 — Adults with type 2 diabetes taking Exubera (insulin [rDNA origin] powder for oral inhalation) alone or in combination with diabetes pills achieved significantly greater improvements in blood sugar levels compared to patients taking pills alone, according to a new study published in the October issue of Annals of Internal Medicine. 

Patients entered the study with A1c levels of 9.5 to 9.6, which is higher than the American Diabetes Association's recommended treatment blood sugar goal of levels less than or equal to 7.  An A1c level indicates a patient's blood sugar control over the last two months to three months. Patients taking inhaled insulin alone achieved an improvement in their A1c levels of 1.4 and patients taking inhaled insulin plus two diabetes pills achieved an improvement of 1.9.  Patients taking pills alone experienced a 0.2 improvement in A1c levels.

"These findings are really encouraging for people with type 2 diabetes," said lead study investigator Dr. Julio Rosenstock, practicing endocrinologist at the Dallas Diabetes and Endocrine Center, and clinical professor of medicine at the University of Texas Southwestern Medical Center in Dallas.  "Exubera resulted in significant improvements in blood sugar control, with marked reductions in A1c levels, which is the ultimate objective for any patient with diabetes." 

The open-label, 12-week, multicenter, randomized study involved 309 male and female patients, 35 years to 80 years old, with uncontrolled type 2 diabetes and taking two diabetes pills.  Patients were then randomized to switch to inhaled insulin, add inhaled insulin to their regimen of two diabetes pills or remain on two diabetes pills.

There were no treatment-related discontinuations due to adverse events in any of the groups during the study.  Consistent with improved blood sugar control attributed to insulin therapies, hypoglycemia was more common with inhaled insulin treatment.  Cough, which was observed with greater frequency in patients taking inhaled insulin, was generally mild and decreased in incidence and prevalence during the study.  Pulmonary function changes were comparable between groups.  Increases in insulin antibody levels were observed in the inhaled insulin group but did not appear to have any clinical consequences.

An estimated 194 million people worldwide have diabetes, and about 95 percent of those have the type 2 form of the disease.  In type 2 diabetes, the body's pancreas cannot manufacture enough insulin to manage blood sugar levels.  Type 2 diabetes progresses over time, and eventually most people with type 2 diabetes will need insulin to achieve blood sugar control. 

According to a recent report, 67 percent of Americans with diabetes have blood sugar levels that are not controlled and are above the levels recommended in the national treatment guidelines.  Although insulin is an effective treatment for diabetes, health care providers and patients are often reluctant to initiate or intensify insulin treatment.6  The reasons for this include concerns about lifestyle changes, compliance, disease progression and injection-related factors, such as fear of injection.  Many individuals may delay insulin use for as many as five to 10 years.

Complications commonly associated with uncontrolled or poorly controlled diabetes include cardiovascular disease, kidney failure and blindness.  Diabetes and its complications are estimated to account for $132 billion in direct and indirect costs annually in the United States.