Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes

NCT ID: NCT00424333

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

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2000-10-31

Brief Summary

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To determine in subjects with Type 1 Diabetes Mellitus:

1. Whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin.
2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

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 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 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

Duarte, 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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Stanford, California, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Tallahassee, Florida, United States

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Peoria, Illinois, United States

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Skokie, Illinois, United States

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Lutherville, Maryland, United States

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Waltham, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Columbia, Missouri, United States

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New Hyde Park, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Burlington, Vermont, United States

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Charlottesville, Virginia, United States

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Charlottsville, Virginia, United States

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Seattle, Washington, United States

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Edmonton, Alberta, Canada

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Hamilton, Ontario, Canada

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Mississauga, Ontario, Canada

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Toronto, Ontario, 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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217-107

Identifier Type: -

Identifier Source: org_study_id

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