Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

Stopped early · Phase 3

Conditions studied: Diabetes Mellitus, Type 1

In brief

This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin). This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

Key facts

Study ID

NCT00137046

Run by

Pfizer

People needed

582

Starts

2002-05-01

Expected to finish

2008-12-01

Last updated by the study team

2010-02-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes mellitus

You may not qualify if…

• severe asthma or COPD
• smoking
• brittle diabetes

Where it is running

• Pfizer Investigational Site — Winter Park, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Wilmette, Illinois, United States
• Pfizer Investigational Site — Bethesda, Maryland, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Butte, Montana, United States
• Pfizer Investigational Site — New Hyde Park, New York, United States
• Pfizer Investigational Site — Durham, North Carolina, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Lansdale, Pennsylvania, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — Burlington, Vermont, United States
• Pfizer Investigational Site — Richmond, Virginia, United States
• Pfizer Investigational Site — Renton, Washington, United States
• Pfizer Investigational Site — Milwaukee, Wisconsin, United States
• Pfizer Investigational Site — Capital Federal, Buenos Aires, Argentina
• Pfizer Investigational Site — Capital Federal, Buenos Aires, Argentina
• Pfizer Investigational Site — Capital Federal, Buenos Aires, Argentina
• Pfizer Investigational Site — Capital Federal, Buenos Aires, Argentina
• Pfizer Investigational Site — Belo Horizonte, Minas Gerais, Brazil
• Pfizer Investigational Site — Curitiba, Paraná, Brazil
• Pfizer Investigational Site — West Palm Beach, Florida, United States

Full record on ClinicalTrials.gov

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