Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes

NCT ID: NCT00424411

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2000-12-31

Brief Summary

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To determine, in subjects with Type 2 Diabetes Mellitus:

1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day.
2. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.

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 (EXUBERA™)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes
* 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

Burlingame, California, United States

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Irvine, 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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Orange, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Tustin, California, 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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Miami, Florida, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, 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 Hyde Park, 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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Durham, North Carolina, 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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Austin, 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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Charlottesville, Virginia, 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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Red Deer, Alberta, 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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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Chomedy, Quebec, Canada

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Montreal, 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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217-108

Identifier Type: -

Identifier Source: org_study_id

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