Issue 121 Item 11 EASD: Inhaled Insulin Provides Effective Glycemic Control in T

Inhaled, rapid-acting, dry powder insulin (Exubera®) may be used as a convenient alternative to pre-prandial injections in patients with type 1 diabetes. That, from the researchers at the annnual meeting of the European Association for the Study of Diabetes (EASD).

The investigators enrolled a total of 335 patients with type 1 diabetes (between 12 and 65 years of age) in a phase III multicenter study. One-hundred-and-seventy patients were randomly assigned to receive six months of treatment with inhaled insulin (INH) prior to meals, plus a single bedtime injection of long-acting insulin (Ultralente®). INH was delivered in one to two inhalations of 1 mg or 3 mg of dry powder.

The remaining 165 patients received two to three injections of subcutaneous (SC) insulin (regular and NPH). HbA1c levels were measured in all subjects at the beginning of the trial and after 24 weeks of treatment.

The investigators found that HbA1c decreased similarly in both groups during the course of the trial: from 8.1 percent to 7.9 percent in the INH group and from 8.1 percent to 7.7 percent in the SC group.

Interestingly, fasting plasma glucose levels showed a significantly greater reduction in the INH group (-35 mg/dL) than in the SC group (-10 mg/dL; CI: -43.4, -7.0). There was also a significantly greater decrease in two-hour postprandial glucose levels in the INH group (-30 mg/dL) versus the SC group (1 mg/dL; CI: -54.6, -6.0).

Risk of overall hypoglycemia was lower in the INH group than in the SC group (8.6 versus 9.0 events/subject-month; CI: 0.93, 0.99). The frequency and nature of adverse events overall were comparable between groups.

Cough was seen more frequently in the INH group (27 percent versus 5 percent), but was judged as "mild to moderate", and decreased in incidence and prevalence over the study period.

"Many patients with type 1 diabetes fail to achieve good glucose control, possibly due to the burden of multiple injections required to achieve good physiologic control," said Dr. Teresa Quattrin, of Children’s Hospital of Buffalo, New York, USA, who presented the study on behalf of the Exubera Phase III Study Group.

"Our study has shown that multiple daily administration of inhaled insulin, in association with one injection of long-acting insulin, provides glycemic control that is as effective as three injections of insulin," Dr. Quattrin concluded. The research was funded by Pfizer, Inc. and Aventis Pharma, manufacturers of the drugs used in the study.