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Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exubera® (inhaled insulin)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols Exclusion Criteria: Smoking Pregnancy

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exubera® (inhaled insulin)

Arm Description

Open label, no comparator

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in Glycosylated Hemoglobin by Duration of Exubera Treatment
Change from Baseline: mean of (value of observed glycosylated hemoglobin (HbA1C) (percent) 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.
Hypoglycemic Event Rates by Interval of Exubera Treatment
Number of hypoglycemic events per subject-month. Subject-month determined by time on treatment. Interval of treatment based on elapsed duration of treatment in the controlled & uncontrolled studies.Overall represents entire duration of treatment. Hypoglycemia: Characteristic symptoms of hypoglycemia with no blood glucose check. Clinical picture must include prompt resolution with food intake, subcutaneous glucagon or intravenous glucose.OR,Characteristic symptoms of hypoglycemia with blood glucose check showing glucose <=59 mg/dl.OR,Any glucose measurement <=49 mg/dl,with or without symptoms.
Severe Hypoglycemic Event Rates by Interval of Exubera Treatment
Number of severe hypoglycemic events per 100 subject-months.Subject-month determined by time on treatment.Interval of treatment based on elapsed duration of treatment in controlled & uncontrolled studies.Overall represents entire duration of treatment.A severe hypoglycemic event must have met all 3of following:1.subject unable to treat self.2.subject exhibited 1 or more of neurological symptoms defined in protocol.3.blood glucose must be <=49 mg/dl if measured.If not measured,clinical manifestations must have been reversed by oral carbohydrates,subcutaneous glucagon,or intravenous glucose.
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes
Observed values by duration of treatment.
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)
observed values by duration of treatment.
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)
Observed values by duration of treatment.
Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment
Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity.
Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment
Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume.
Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment
Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity.

Full Information

First Posted
August 31, 2005
Last Updated
April 10, 2010
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00143247
Brief Title
Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus
Official Title
An Open-Label, Phase 2, Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus Participating in Extension Protocols 217-102, 103, or 104
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
March 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).
Detailed Description
The study was terminated on Oct. 18, 2007. This study is not a post approval commitment study. Pfizer decided to cancel new trials because of the decision to withdraw Exubera® (inhaled insulin) due to lack of market performance and not for safety reasons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exubera® (inhaled insulin)
Arm Type
Experimental
Arm Description
Open label, no comparator
Intervention Type
Drug
Intervention Name(s)
Exubera® (inhaled insulin)
Other Intervention Name(s)
Exubera®
Intervention Description
Treatment of type 1 and type 2 diabetes with short-acting insulin
Primary Outcome Measure Information:
Title
Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment
Description
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.
Time Frame
Baseline to 126 months
Title
Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment
Description
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.
Time Frame
baseline to 126 months
Secondary Outcome Measure Information:
Title
Change in Glycosylated Hemoglobin by Duration of Exubera Treatment
Description
Change from Baseline: mean of (value of observed glycosylated hemoglobin (HbA1C) (percent) 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.
Time Frame
Baseline to 126 months
Title
Hypoglycemic Event Rates by Interval of Exubera Treatment
Description
Number of hypoglycemic events per subject-month. Subject-month determined by time on treatment. Interval of treatment based on elapsed duration of treatment in the controlled & uncontrolled studies.Overall represents entire duration of treatment. Hypoglycemia: Characteristic symptoms of hypoglycemia with no blood glucose check. Clinical picture must include prompt resolution with food intake, subcutaneous glucagon or intravenous glucose.OR,Characteristic symptoms of hypoglycemia with blood glucose check showing glucose <=59 mg/dl.OR,Any glucose measurement <=49 mg/dl,with or without symptoms.
Time Frame
0 to 132 months
Title
Severe Hypoglycemic Event Rates by Interval of Exubera Treatment
Description
Number of severe hypoglycemic events per 100 subject-months.Subject-month determined by time on treatment.Interval of treatment based on elapsed duration of treatment in controlled & uncontrolled studies.Overall represents entire duration of treatment.A severe hypoglycemic event must have met all 3of following:1.subject unable to treat self.2.subject exhibited 1 or more of neurological symptoms defined in protocol.3.blood glucose must be <=49 mg/dl if measured.If not measured,clinical manifestations must have been reversed by oral carbohydrates,subcutaneous glucagon,or intravenous glucose.
Time Frame
0-132 months
Title
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes
Description
Observed values by duration of treatment.
Time Frame
36 months to 126 months
Title
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)
Description
observed values by duration of treatment.
Time Frame
36 to 126 months
Title
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)
Description
Observed values by duration of treatment.
Time Frame
6 to 120 months
Title
Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment
Description
Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity.
Time Frame
3 to >=108 months
Title
Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment
Description
Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume.
Time Frame
3 to >=108 months
Title
Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment
Description
Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity.
Time Frame
6 to >=108 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols Exclusion Criteria: Smoking Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5666
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171036&StudyName=An%20Optional%20Roll-Over%20Extension%20of%20Previous%20Phase%202%20Available%20to%20Patients%20Who%20Participated%20in%20Previous%20Phase%202%20Studies.
Description
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Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus

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