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Efficacy and Safety of Inhaled Insulin Therapy
- Julio Rosenstock, MD;
- Bernard Zinman, MD;
- Liam J. Murphy, MD;
- Stephen C. Clement, MD;
- Paul Moore, MD;
- C. Keith Bowering, MD;
- Rosa Hendler, MD;
- Shu-Ping Lan, MPH; and
- William T. Cefalu, MD
- From Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.
IN RESPONSE:
We agree that a limitation of our study was the open-label design. However, a double-blind study was not feasible because 1) it was not possible to manufacture a suitable placebo for inhaled human insulin, 2) it seemed inappropriate to blind treatment when individualized flexible-dose titration is needed, and 3) patients or physicians would have very easily unblinded the placebo or inhaled insulin because of the latter's immediate effect on blood glucose levels.
Ours was a proof-of-concept study that was designed in 1998 according to good clinical practices at the time and was based on a previous study of similar design (1). We do not believe there were any ethical issues for patients who were randomly assigned to the control group because microvascular complications are associated with long-term hyperglycemia, and there is no evidence that a relatively short period of inadequate glucose control will …
