Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

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.

Timeline

Start

2006-08

Primary completion

2008-05

Completion

2008-05

Publications

• Comulada AL, Renard E, Nakano M, Rais N, Mao X, Webb DM, Milicevic Z. Efficacy and safety of AIR inhaled insulin compared to insulin lispro in patients with type 1 diabetes mellitus in a 6-month, randomized, noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S17-25. doi: 10.1089/dia.2009.0041.

Drugs

Indications