Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Diabetes Mellitus, Type 1

Eligibility:

All Genders

12-65 years

Phase:

PHASE3

Brief Summary

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 plu...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

May 1 1999

Trial Type :

INTERVENTIONAL

End Date :

October 1 2000

Estimated Enrollment :

320 Patients enrolled

Trial Details

Trial ID

NCT00424333

Start Date

May 1 1999

End Date

October 1 2000

Last Update

February 13 2007

Active Locations (35)

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Page 1 of 9 (35 locations)

1

Pfizer Investigational Site

Duarte, California, United States

2

Pfizer Investigational Site

Long Beach, California, United States

3

Pfizer Investigational Site

Los Angeles, California, United States

4

Pfizer Investigational Site

Stanford, California, United States