Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes

Summary

To determine in subjects with Type 1 Diabetes Mellitus: 1. Whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin. 2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.

Timeline

Start

1999-05

Primary completion

—

Completion

2000-10

Drugs

Indications