Diabetes and cancer treatments developer MannKind has initiated patient enrollment in two pivotal 12-month phase III clinical trials of its Technosphere Insulin in patients with type 1 and type 2 diabetes.
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, MannKind have begun all but one of their pivotal trials for US approval of Technosphere Insulin, says Alfred Mann, MannKind chairman and CEO.