Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This study is being done to find out the good and bad effects of a drug that is not approved
for sale and the effects if any on measures of pulmonary function in adult males and females
with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).
This study included a 2-year comparative treatment period followed by a 6-month follow-up
period during which inhaled insulin-treated subjects were switched back to subcutaneous
short-acting insulin. After this follow-up period, all eligible subjects entered a
comparative extension period that was to last for 5 years. When the comparative portion of
the study was terminated, all subjects were requested to return for a final extension
follow-up month 3 visit.