Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 1

In brief

To determine in subjects with Type 1 Diabetes Mellitus: 1. Whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin. 2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.

Key facts

Study ID

NCT00424333

Run by

Pfizer

People needed

320

Starts

1999-05-01

Expected to finish

2000-10-01

Last updated by the study team

2007-02-13

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 Diabetes for more than 1 year
• Stable insulin regimen of at least 2 injections per day

You may not qualify if…

• Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
• Subjects on insulin pump during 2 months prior to screening.
• Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.

Where it is running

• Pfizer Investigational Site — Duarte, California, United States
• Pfizer Investigational Site — Long Beach, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Stanford, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Hollywood, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Tallahassee, Florida, United States
• Pfizer Investigational Site — Peoria, Illinois, United States
• Pfizer Investigational Site — Skokie, Illinois, United States
• Pfizer Investigational Site — Lutherville, Maryland, United States
• Pfizer Investigational Site — Waltham, Massachusetts, United States
• Pfizer Investigational Site — Minneapolis, Minnesota, United States
• Pfizer Investigational Site — Columbia, Missouri, United States
• Pfizer Investigational Site — New Hyde Park, New York, United States
• Pfizer Investigational Site — Rochester, New York, United States
• Pfizer Investigational Site — Syracuse, New York, United States
• Pfizer Investigational Site — The Bronx, New York, United States
• Pfizer Investigational Site — Durham, North Carolina, United States
• Pfizer Investigational Site — Winston-Salem, North Carolina, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States
• Pfizer Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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