A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine

A Phase 2 Randomized, Open Label, Multi-Center Study of the Use of Prandial Inhaled Technosphere Insulin in Combination With Basal Subcutaneous Lantus as Basal Insulin Versus Prandial Subcutaneous NovoRapid in Combination With Basal Subcutaneous Lantus Insulin in Subjects With Type 1 Diabetes Mellitus

A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine

Inclusion Criteria:

• Type 1 diabetes currently receiving SC insulin at mealtimes for at least 3 months
• BMI <40 kg/m squared
• HbA1c greater than or equal to 7% and less than or equal to 11.5%
• Serum creatinine less than 2 for males and less than 1.8 for females
• Acceptable pulmonary function

Exclusion Criteria:

• Significant hepatic disease
• Previously diagnosed pulmonary disease, ketoacidosis of evidence of severe secondary complications of diabetes