NCT00143247

Brief Summary

This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2 diabetes-mellitus

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 9, 2009

Completed
Last Updated

April 15, 2010

Status Verified

July 1, 2009

Enrollment Period

4.8 years

First QC Date

August 31, 2005

Results QC Date

January 16, 2009

Last Update Submit

April 10, 2010

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment

    Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.

    Baseline to 126 months

  • Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment

    Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.

    baseline to 126 months

Secondary Outcomes (9)

  • Change in Glycosylated Hemoglobin by Duration of Exubera Treatment

    Baseline to 126 months

  • Hypoglycemic Event Rates by Interval of Exubera Treatment

    0 to 132 months

  • Severe Hypoglycemic Event Rates by Interval of Exubera Treatment

    0-132 months

  • Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes

    36 months to 126 months

  • Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)

    36 to 126 months

  • +4 more secondary outcomes

Study Arms (1)

Exubera® (inhaled insulin)

EXPERIMENTAL

Open label, no comparator

Drug: Exubera® (inhaled insulin)

Interventions

Exubera® (inhaled insulin)DRUG

Treatment of type 1 and type 2 diabetes with short-acting insulin

Also known as: Exubera®
Exubera® (inhaled insulin)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols

You may not qualify if:

  • Smoking
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pfizer Investigational Site

San Diego, California, 92123, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06504, United States

Location

Pfizer Investigational Site

Miami, Florida, 33136, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60610, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87131-5666, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27157, United States

Location

Pfizer Investigational Site

Austin, Texas, 78752, United States

Location

Pfizer Investigational Site

Austin, Texas, 78758, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75243, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Exubera

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Study terminated early due to business and operational issues. All subjects who were treated with inhaled insulin in parent protocols(217-102,-103,or-104) or in extension protocols (217-102E,-103E,-104E,or A2171036)are included in safety evaluation.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

March 1, 2003

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

April 15, 2010

Results First Posted

November 9, 2009

Record last verified: 2009-07

Locations

US(12)