The main objective of these studies is to evaluate the efficacy of Technosphere Insulin (TI) by assessing changes both in HbA1c levels as well as in blood glucose levels after a standardized meal.
The first of these new trials, Study 009, is a 12-month phase III efficacy study in 500 type 1 patients. In this study, TI will be compared to subcutaneous injections of a rapid-acting insulin analog. Patients in both arms of this study will also receive a basal insulin regimen.
The second of these trials, Study 102, was the subject of a special protocol assessment by the FDA in autumn 2005. This trial will compare TI plus basal insulin to subcutaneous injections of premixed insulin (including a rapid-acting insulin analog) over a 12-month period in 500 type 2 diabetes patients.
“With these latest trial initiations, we have begun all but one of our pivotal trials for US approval of Technosphere Insulin,” commented Alfred Mann, MannKind chairman and CEO. “The last remaining major trial, Study 103, is scheduled to begin sometime this summer. We also plan to initiate a number of additional studies intended to further show the advantages of Technosphere Insulin over other treatment regimens.”