A 2-Month Safety Follow-Up Trial

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030)

• Urine cotinine test of less than or equal to 100 ng/mL

• Written informed consent

Exclusion Criteria:

• Subjects who started smoking during the 4 week follow-up phase of the parent trial

• Subjects who began a new inhaled insulin regimen with an investigational drug during the 4 week follow-up phase of the parent trial and/or are participation in another clinical trial

• Female subjects who are pregnant, lactating or planning on becoming pregnant

• Subjects with a positive urine drug screening at Visit 1

• Female subjects of child-bearing potential not practicing adequate birth control