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Inhaled Insulin Appears More Effective than Subcutaneous Formulation: Presented at AACE
By Bruce Sylvester
Special to DG News
CHICAGO, IL -- May 3, 2002 -- The investigational inhaled insulin agent ExuberaŽ is well-tolerated by patients with Type 1 diabetes and reduces fasting plasma glucose and two-hour post-prandial glucose levels significantly more effectively than does conventional subcutaneous insulin treatment.
Researchers reported the findings from their multicenter study here today at the 11th annual meeting of the American Association of Clinical Endocrinologists (AACE) in Chicago, Illinois, United States.
"This treatment by inhalation -- pre-meal and in association with one injection of long-acting insulin -- provides comparable control with less incidence of blood sugar reactions, which is a major concern in diabetes treatment," said Exubera phase III study group researcher Teresa Quattrin, MD, associate professor of medicine at the State University of New York Medical School in Buffalo. "It was safe, well-tolerated and really made life better for the patients, according to the 'treatment satisfaction' questionnaires."
"This form of delivering insulin is novel, noninvasive and provides comparable diabetes control to the conventional regimen, which requires two to three injections daily," Dr. Quattrin added.
For this open-label, randomized, six-month study, investigators enrolled 335 subjects aged 12 to 65 years who had been diagnosed with diabetes mellitus for at least one year. They participated for two months prior to study entry in a stable subcutaneous insulin regimen with at least two insulin or insulin analog injections per day.
In the study, 170 patients received insulin delivered as one to two inhalations of 1 mg and 3 mg before meals, plus one bedtime injection of UltralenteŽ. One hundred and sixty-five subjects received two to three subcutaneous injections insulin or insulin analog.
The primary efficacy end point was the change in glycemic control (change in HbA1c) from baseline to week 24.
At week 24, the HbA1c reduction was from 8.1 percent to 7.9 percent in the inhaled insulin group and from 8.1 percent to 7.7 percent in the subcutaneous injection group. Fasting plasma glucose and two-hour post-prandial glucose readings showed significantly greater reductions in the inhaled insulin group, with -35 mg/dL and -30mg/dL for the inhaled insulin group and -10 mg/dL and 1 mg/dL for the subcutaneous insulin group.
A total of 58.0 percent and 15.9 percent respectively reached an HbA1c level below 8 percent and below 7 percent for the inhaled insulin group, and 61.9 percent and 15.5 percent respectively for the subcutaneous insulin group.
A greater improvement in satisfaction with treatment among patients treated with inhaled insulin than in those treated with subcutaneous insulin.
Patients treated with inhaled insulin had a lower risk of hypoglycemic events (measured in events/subject per month; (8.6) than did patients treated with subcutaneous insulin (9.0; CI: 0.93. 0.99). The difference in severe events was not significant (5.5 vs. 4.7 events per 100 subjects per month respectively).
The researchers concluded that inhaled insulin "may provide a valuable noninvasive therapy for people with type 1 diabetes".
The study was sponsored by Pfizer Global Research and Development and Inhale Therapeutic Systems.
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