Mar 7 2006
MannKind Corporation has announced that it has initiated patient enrollment in two pivotal 12-month Phase 3 clinical trials of Technosphere Insulin (TI) in patients with Type 1 and Type 2 Diabetes.
The main objective of these studies is to evaluate the efficacy of 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 3 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 the fall of 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.
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