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

NCT ID: NCT00370565

Last Updated: 2007-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2000-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Inhaled Human Insulin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Nektar Therapeutics

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Irvine, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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Tustin, California, United States

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New Britain, Connecticut, United States

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New Haven, Connecticut, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Clearwater, Florida, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Minneapolis, Minnesota, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Greenville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Burlington, Vermont, United States

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Renton, Washington, United States

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Red Deer, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Countries

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United States Canada

Related Links

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Other Identifiers

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217-109

Identifier Type: -

Identifier Source: org_study_id

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