Status:
COMPLETED
Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
Lead Sponsor:
Mannkind Corporation
Conditions:
Diabetes, Type I
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 1 diabetes for at least 1 year
- Nonsmokers for prior 6 months
- BMI less than or equal to 35kg/m2
- HbA1c \> or = 7% and \< or = 11%
- Serum creatinine \< or = 1.8 mg/dL in female subjects and \< or = 2.0 mg/dL in male subjects
- FEV1 \> or = 70% of predicted, DLco \> or = 70% , TLC \> or = 80% predicted
- Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
- Urine cotinine \< or = 100 ng/mL
Exclusion
- History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
- Evidence of severe complications of diabetes
- Aminotransferase and/or alanine aminotransferase \> than 3 times the upper limit of normal
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
589 Patients enrolled
Trial Details
Trial ID
NCT00308308
Start Date
February 1 2006
End Date
August 1 2008
Last Update
October 16 2014
Active Locations (129)
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1
Coastal Clinical Research Inc
Mobile, Alabama, United States, 36608
2
Radiant Research (Phoenix)
Chandler, Arizona, United States, 85225
3
International Clinical Research Network
Chula Vista, California, United States, 91911
4
Family Medical Center
Foothill Ranch, California, United States, 92610