Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

February 9, 2007 updated by: Pfizer

Efficacy And Safety Of Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial.

To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

345

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, T3B 0M3
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T6G 2C8
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T6G 2S2
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T5H 3V9
        • Pfizer Investigational Site
      • Red Deer, Alberta, Canada, T4N 6V7
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Pfizer Investigational Site
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Pfizer Investigational Site
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Pfizer Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 1X5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5B 1WB
        • Pfizer Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Pfizer Investigational Site
  • United States
    • California
      • Irvine, California, United States, 92618
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90073
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90059
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92663
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • Tustin, California, United States, 92780
        • Pfizer Investigational Site
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06519
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06510
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Pfizer Investigational Site
      • Hollywood, Florida, United States, 33021
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33607
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10025
        • Pfizer Investigational Site
      • New York, New York, United States, 10016
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642
        • Pfizer Investigational Site
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • Pfizer Investigational Site
      • Winston-salem, North Carolina, United States, 27157
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78758
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75235-8858
        • Pfizer Investigational Site
      • Irving, Texas, United States, 75061
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, United States, 98055
        • 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

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.
  • Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).

Exclusion Criteria:

  • Asthma, COPD
  • Smoking during the previous 6 months

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
The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.

Secondary Outcome Measures

Outcome Measure
Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)
Meal glucose response measured at Week -1 and at Week 12;
These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
not the subject's home glucose monitoring results.
Comparison of 24-hour home glucose profiles.
Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight.
A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.

Collaborators and Investigators

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

Sponsor

Pfizer

Collaborators

Sanofi
Nektar Therapeutics

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

June 1, 1999

Study Completion

September 1, 2000

Study Registration Dates

First Submitted

August 29, 2006

First Submitted That Met QC Criteria

August 29, 2006

First Posted (Estimate)

August 31, 2006

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

  • 217-109

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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