US Inhaled Insulin Dose Titration Study

NCT ID: NCT00246623

Last Updated: 2008-02-08

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-03-31

Brief Summary

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This study will examine how to dose Exubera (inhaled insulin) in patients who are not well controlled on two or more diabetes pills. This study should show that a large number of patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that have been set by the American Diabetes Association (ADA). Target goals should be achieved by adjusting the Exubera dose either weekly or twice weekly. Patients will also receive nutritional counseling and diabetes education as part of the study.

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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Exubera (inhaled insulin)

Intervention Type DRUG

8-point glucose diary (to assess pre- and post prandial glucoses)

Intervention Type PROCEDURE

Meal Tolerance Test

Intervention Type PROCEDURE

24-hour continuous glucose monitoring (at select sites)

Intervention Type PROCEDURE

Pulmonary Function Testing

Intervention Type PROCEDURE

Hypoglycemic Event Monitoring

Intervention Type PROCEDURE

Laboratory Assessments

Intervention Type PROCEDURE

Nutritional Counseling and Diabetes Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male and female, age \>= 18 years and \<= 80 years, with a diagnosis of type 2 diabetes made at least 6 months prior to study entry, with hemoglobin A1C 7.5-10%
* Currently treated with 2 or more oral antidiabetic agents (sulfonylureas, metformin, and/or thiazolidinediones)

Exclusion Criteria

* Type 1 diabetes
* Smoking within the past 6 months or significant pulmonary diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

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

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

New Britain, Connecticut, United States

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Pfizer Investigational Site

Norwalk, Connecticut, United States

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Pfizer Investigational Site

Hollywood, Florida, United States

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Pfizer Investigational Site

Atlanta, Georgia, United States

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Pfizer Investigational Site

Boise, Idaho, United States

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Pfizer Investigational Site

Hayden, Idaho, United States

Site Status

Pfizer Investigational Site

Baton Rouge, Louisiana, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Albany, New York, United States

Site Status

Pfizer Investigational Site

Syracuse, New York, United States

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Pfizer Investigational Site

Dallas, Texas, United States

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Pfizer Investigational Site

El Paso, Texas, United States

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Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

Bennington, Vermont, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A2171067

Identifier Type: -

Identifier Source: org_study_id

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