Status:
COMPLETED
Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Lead Sponsor:
Mannkind Corporation
Conditions:
Diabetes, Type 1
Diabetes, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Pulmonary Safety in Diabetics with T/I
Eligibility Criteria
Inclusion
- For All Subjects:
- Nonsmoking
- Body mass index \<42 kg/m2
- FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening,
- No abnormalities in screening pulmonary radiology
- For Subjects with diabetes mellitus:
- Type 1 or type 2 diabetes for at least 2 years
- HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %
- For Subjects without abnormalities in glucose control:
- No history of diabetes
- Normal results from a formal glucose tolerance test
Exclusion
- History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
- Significant renal, hepatic, or cardiac disease
- Women who are pregnant, lactating, or planning on becoming pregnant
- Subjects who have participated in studies of other investigational drugs within the previous 3 months
- Evidence of severe complications of diabetes
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
2053 Patients enrolled
Trial Details
Trial ID
NCT00308737
Start Date
June 1 2005
End Date
October 1 2008
Last Update
October 16 2014
Active Locations (176)
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1
Southwest Health Ltd Research Division
Phoenix, Arizona, United States, 85016
2
Lovelace Scientific Resources
Phoenix, Arizona, United States, 85018
3
Northwest Medical Center
Phoenix, Arizona, United States, 85029
4
Arizona Center for Clinical Research
Phoenix, Arizona, United States, 85032