Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes
Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
Summary
A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin
Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable
insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with
type 1 diabetes mellitus.
This study is designed also to examine insulin antibody levels in AIR Insulin -treated
patients compared with injectable insulin-treated patients with type 1 diabetes.
The present study is intended to determine if preprandial AIR Insulin is non-inferior to
preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from
baseline to endpoint at 6 months in patients with type 1 diabetes.