Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.

The secondary endpoints include the following efficacy assessments:

Incidence of hypoglycemia

Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)

Change from baseline in fasting lipid profile

Change from baseline in fasting plasma glucose level

Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)

Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).

Change from baseline in body weight

Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments).

Patient satisfaction and preference.