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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
345

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 1999

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2000

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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