Wednesday, November 2, 2005 — Adults with type 2 diabetestaking Exubera (insulin [rDNA origin] powder for oral inhalation) alone or incombination with diabetes pills achieved significantly greater improvements inblood sugar levels compared to patients taking pills alone, according to a newstudy 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 treatmentblood sugar goal of levels less than or equal to 7.  An A1c levelindicates a patient’s blood sugar control over the last two months to threemonths. Patients taking inhaled insulin alone achieved an improvement in theirA1c levels of 1.4 and patients taking inhaled insulin plus two diabetes pillsachieved an improvement of 1.9.  Patients taking pills alone experienced a0.2 improvement in A1c levels.

“These findings are really encouraging for peoplewith type 2 diabetes,” said lead study investigator Dr. Julio Rosenstock,practicing endocrinologist at the Dallas Diabetes and Endocrine Center, andclinical professor of medicine at the University of Texas Southwestern MedicalCenter in Dallas.  “Exubera resulted in significant improvements inblood sugar control, with marked reductions in A1c levels, which is theultimate objective for any patient with diabetes.” 

The open-label, 12-week, multicenter, randomized studyinvolved 309 male and female patients, 35 years to 80 years old, withuncontrolled type 2 diabetes and taking two diabetes pills.  Patients werethen randomized to switch to inhaled insulin, add inhaled insulin to theirregimen of two diabetes pills or remain on two diabetes pills.

There were no treatment-related discontinuations due toadverse events in any of the groups during the study.  Consistent withimproved blood sugar control attributed to insulin therapies, hypoglycemia wasmore common with inhaled insulin treatment.  Cough, which was observedwith greater frequency in patients taking inhaled insulin, was generally mildand decreased in incidence and prevalence during the study.  Pulmonaryfunction changes were comparable between groups.  Increases in insulinantibody levels were observed in the inhaled insulin group but did not appearto 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.  Intype 2 diabetes, the body’s pancreas cannot manufacture enough insulin tomanage blood sugar levels.  Type 2 diabetes progresses over time, andeventually most people with type 2 diabetes will need insulin to achieve bloodsugar control. 

According to a recent report, 67 percent of Americanswith diabetes have blood sugar levels that are not controlled and are above thelevels recommended in the national treatment guidelines.  Although insulinis an effective treatment for diabetes, health care providers and patients areoften reluctant to initiate or intensify insulin treatment.6  The reasonsfor this include concerns about lifestyle changes, compliance, diseaseprogression 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 orpoorly controlled diabetes include cardiovascular disease, kidney failure andblindness.  Diabetes and its complications are estimated to account for$132 billion in direct and indirect costs annually in the United States.