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

February 9, 2007 updated by: Pfizer

Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Pfizer Investigational Site
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada
        • Pfizer Investigational Site
    • Quebec
      • Laval, Quebec, Canada
        • Pfizer Investigational Site
  • United States
    • California
      • 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
    • Connecticut
      • Hartford, Connecticut, United States
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • Pfizer Investigational Site
      • Stockbridge, Georgia, United States
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States
        • Pfizer Investigational Site
      • St Louis, Missouri, United States
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Pfizer Investigational Site
    • New York
      • 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
    • North Carolina
      • Greenville, North Carolina, United States
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States
        • Pfizer Investigational Site
      • Dallas, Texas, United States
        • Pfizer Investigational Site
      • Irving, Texas, United States
        • Pfizer Investigational Site
      • San Antonio, Texas, United States
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary outcome is 24 week change in baseline in HbA1c

Secondary Outcome Measures

Outcome Measure
The secondary endpoints include the following efficacy assessments:
Incidence of hypoglycemia
Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
Change from baseline in fasting lipid profile
Change from baseline in fasting plasma glucose level
Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
Change from baseline in body weight
Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments).
Patient satisfaction and preference.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Study Completion

September 1, 2000

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (Estimate)

January 19, 2007

Study Record Updates

Last Update Posted (Estimate)

February 13, 2007

Last Update Submitted That Met QC Criteria

February 9, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217-106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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