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Title: Inhaled Human Insulin Comparable to Injectable Insulin in Type 1 Diabetics: Presented at ACCP

"Inhaled Human Insulin Comparable to Injectable Insulin in Type 1 Diabetics: Presented at ACCP"

By Maria Bishop BOSTON, MA -- September 20, 2006 -- The glucose-lowering activity of the new inhaled human insulin (INH) (Exubera) is generally comparable to that of subcutaneous insulin in patients with type 1 diabetes mellitus, researchers reported here at the American College of Clinical Pharmacology 35[^th Annual Meeting (ACCP).

Results of an open-label, 4-way, randomized-sequence, crossover study of 22 adult subjects with type 1 diabetes show no significant difference in glucose responses or safety parameters.

Study subjects had a mean age of 32 years and all but 1 were white. Subjects had no previous experience with INH, whereas injection of subcutaneous insulin was routine. Therefore, results on study subjects may be somewhat atypical for INH compared with results in those who are regular users of INH, noted lead investigator Robert J. Fountaine, PharmD, Pfizer Global Research and Development, Groton, Connecticut.

Each subject self-administered 2 doses of INH and subcutaneous insulin on separate study days, each 10 minutes before consumption of a standard high-carbohydrate liquid breakfast (approximately 60% of kcal from carbohydrates). The washout period ranged from 1 to 21 days.

Blood samples were collected to measure serum-free insulin and plasma glucose concentrations at specified intervals, beginning 30 minutes before until 6 hours after INH dosing. Postprandial glucose concentrations were measured after each minute, for up to 360 minutes, by a glucose clamp device.

The researchers concluded that the within-subject reproducibility of the glucose-lowering activity of INH was generally comparable to that of regular insulin in type 1 patients. They stressed that optimal glycemic control and safety are best achieved when an exogenously administered insulin exhibits pharmacokinetic and pharmacodynamic profiles that are reproducible within a patient.

This study was funded by Pfizer Inc., manufacturers of Exubera.

[Presentation title: Pharmacologic Reproducibility of Prandial Inhaled Human Insulin (Exubera [insulin human {rDNA origin}] Inhalation Powder) in Subjects with Type 1 Diabetes Mellitus. Abstract 110]

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