Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

To determine, in subjects with Type 2 Diabetes Mellitus: 1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day. 2. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.

Key facts

Study ID

NCT00424411

Run by

Pfizer

People needed

300

Starts

1999-09-01

Expected to finish

2000-12-01

Last updated by the study team

2007-02-13

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 Diabetes
• 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 — Los Angeles, California, United States
• Pfizer Investigational Site — Newport Beach, California, United States
• Pfizer Investigational Site — Orange, 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 — New Haven, Connecticut, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — New Orleans, Louisiana, 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 — New Hyde Park, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Rochester, New York, United States
• Pfizer Investigational Site — Durham, North Carolina, United States
• Pfizer Investigational Site — Greenville, North Carolina, United States
• Pfizer Investigational Site — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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