Phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

Condition	Intervention	Phase
Diabetes	Drug: Inhaled insulin	Phase III

Further Study Details: 

Expected Total Enrollment:  400

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: Type 1 diabetes, non smoker, normal lung function. -

Exclusion Criteria:Significant pulmonary, hepatic, or renal disease; severe congestive heart failure; active malignancy; systemic glucocorticoid therapy.

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Please refer to this study by ClinicalTrials.gov identifier  NCT00127634

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or      1-317-615-4559 

Florida
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Jacksonville,  Florida,  32204,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Palm Harbor,  Florida,  34652,  United States; Recruiting
New Jersey
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., North Plainfield,  New Jersey,  07060,  United States; Recruiting
New York
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Flushing,  New York,  11365,  United States; Recruiting
North Carolina
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Morehead City,  North Carolina,  28557,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Winston Salem,  North Carolina,  27103,  United States; Recruiting
Washington
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Renton,  Washington,  98055,  United States; Recruiting
Wisconsin
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Milwaukee,  Wisconsin,  53209,  United States; Recruiting

Study chairs or principal investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM – 5 PM Eastern time (UTC/GMT - 5 hours, EST),  Study Director,  Eli Lilly and Company   

Study ID Numbers:  6120
Last Updated:  August 5, 2005
Record first received:  August 4, 2005
ClinicalTrials.gov Identifier:  NCT00127634
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23