Status:
COMPLETED
A 2-Month Safety Follow-Up Trial
Lead Sponsor:
Mannkind Corporation
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Brief 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...
Detailed Description
This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this trial. The adverse e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
649 Patients enrolled
Trial Details
Trial ID
NCT00741429
Start Date
May 1 2007
End Date
September 1 2008
Last Update
December 3 2014
Active Locations (150)
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1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
2
Coastal Clinical Research Inc
Mobile, Alabama, United States, 36608
3
Radiant Research (Phoenix)
Chandler, Arizona, United States, 85225
4
Southwest Health Ltd Research Division
Phoenix, Arizona, United States, 85016