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Inhaled Insulin More Effective as Adjunctive Control of Type 2 Diabetes Than Conventional Therapy: Presented at ERS

By Crystal Phend

GLASGOW, SCOTLAND -- September 14, 2004 -- Inhaled insulin (Exubera) appears to be a better adjunctive treatment for poorly controlled type 2 diabetes than conventional oral medications.

"New ways of delivering insulin without the need for injections may help in the early adoption of insulin treatment by patients, assist in achieving and maintaining long-term optimal glycemic control, and improve patients' quality of life," said John G. Teeter, Pfizer Global Research and Development, Groton, Connecticut.

The ongoing open-label study presented here on September 7^th at the European Respiratory Society 14^th Annual Congress randomized patients into two groups. The 311 subjects in the experimental group received pre-meal inhaled insulin with adjunctive metformin at 1 g twice a day throughout the study. The 265 conventional group received glibenclamide at 5 mg twice daily for 24 weeks and up to 15 mg a day until week 104. The inhaled insulin was administered as a dry powder and the initial daily dose was based on body weight.

Pulmonary function tests, including forced expiratory volume in 1 second (FEV₁) and diffusing capacity carbon monoxide DLCO, were done initially and at weeks 24, 36 and 52. However, there was no significant difference in pulmonary function between the two groups.

Inhaled insulin reduced levels of hemoglobin A_1C (HbA_1C) more than conventional oral therapy, particularly in patients with higher baseline levels. Both groups improved from 9.6% HbA_1C at baseline to 7.6% for the experimental therapy group and 7.8% for the conventional therapy group.

The most common adverse event with inhaled therapy was hypoglycemia, which was greater among patients on inhaled therapy. Mild to moderate cough was also more common in the inhaled insulin group (11.5% vs. 5.0%). However, this was not associated with excessive declines in FEV₁, said Dr. Teeter. There was no difference in the rate of major adverse events, one in each group.

Inhaled insulin has been proposed as a treatment for diabetes since the 1920s and although several are in development, none are yet approved for use.


[Presentation title: "One-Year Pulmonary Safety and Efficacy of Inhaled Insulin as Adjunctive Therapy in Type 2 Diabetes Patients Poorly Controlled on Oral Agent Monotherapy." Poster 3773]

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