Inhaled Insulin May Improve Glycemic Control Without Altering Pulmonary Function

Inhaled insulin improves glycemic control when added to oral agents in type 2 diabetes without altering pulmonary function. Hemoglobin A1C level less than 7% was achieved by 32% of patients receiving inhaled insulin plus oral agents compared with 1% of those receiving oral agent therapy.

"Patients with type 2 diabetes who do not achieve glycemic control with oral agent therapy eventually require insulin," write Julio Rosenstock, MD, from the Dallas Diabetes and Endocrine Center at Medical City in Texas, and colleagues. "Compared with injected regular insulin, inhaled insulin is more rapidly absorbed and eliminated and has a more rapid glucose-lowering effect."

At 48 outpatient centers in the U.S. and Canada, 309 patients with type 2 diabetes, no clinically significant respiratory tract disease, and hemoglobin A1C level of 8% to 11% who were receiving dual oral therapy were randomized to treatment with inhaled insulin (Exubera), titrated to blood glucose, administered alone (n = 104) or added to dual oral agents (n = 103) vs oral therapy alone (n = 99). The main outcome was change in hemoglobin A1C level from baseline to 12 weeks, and secondary endpoints included hemoglobin A1C level less than 8% and less than 7%, hypoglycemia, weight, lipid levels, pulmonary function, insulin antibody binding, and adverse events.

The inhaled insulin group had greater reductions in hemoglobin A1C. Adjusted treatment group differences for inhaled insulin plus oral agents and inhaled insulin alone vs continued oral agent therapy were -1.67 percentage points (95% confidence interval [CI], -1.90 to -1.44 percentage points; P < .001) and -1.18 percentage points (95% CI, -1.41 to -0.95 percentage point; P < 0001), respectively.

Hemoglobin A1C level less than 7% was achieved by 32% of patients receiving inhaled insulin plus oral agents compared with 1% of those receiving oral agent therapy (adjusted odds ratio, 44.7; 95% CI, 6.0 – 335.2). Hypoglycemia, mild weight gain, mild cough, and insulin antibodies occurred more often in the inhaled insulin group than in the group receiving only oral agent therapy. Pulmonary function was not significantly different between groups.

"Inhaled insulin improved overall glycemic control and hemoglobin A1C level when added to or substituted for dual oral agent therapy with an insulin secretagogue and sensitizer," the authors write. "Consistent with other insulin therapies, hypoglycemia and mild weight gain occurred…. Noninvasive insulin delivery methods may increase acceptance of insulin, thus facilitating better glycemic control and improved long-term treatment outcomes in patients with type 2 diabetes."
Ann Intern Med. 2005;143:549-558, 609-610

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