Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

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.

Inclusion Criteria:

• Type 1 diabetes for at least 24 months
• Have an HbA1c less than or equal to 11%
• Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
• Non-smoker

Exclusion Criteria:

• Require a daily total insulin dosage greater than 150 U at screening
• Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
• Systemic glucocorticoid therapy
• Clinical signs or symptoms of liver disease, acute or chronic hepatitis
• History of lung transplantation and/or lung cancer
• Diagnosed with pneumonia in the 3 months prior to screening
• History of renal transplantation
• Active or untreated malignancy