Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.

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 an insulin regimen involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin injections per day. 2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.

Key facts

Study ID

NCT00424437

Run by

Pfizer

People needed

320

Starts

1999-09-01

Expected to finish

2000-09-01

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 — Burlingame, California, United States
• Pfizer Investigational Site — Irvine, California, United States
• Pfizer Investigational Site — Newport Beach, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — Tustin, California, United States
• Pfizer Investigational Site — Hartford, Connecticut, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Stockbridge, Georgia, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Columbia, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Omaha, Nebraska, United States
• Pfizer Investigational Site — Albuquerque, New Mexico, United States
• Pfizer Investigational Site — Buffalo, New York, United States
• Pfizer Investigational Site — Manhasset, New York, United States
• Pfizer Investigational Site — New Hyde Park, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Greenville, North Carolina, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Austin, Texas, United States
• Pfizer Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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