Clinical trial NCT00143247: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment
timeFrame: Baseline to 126 months
measure: Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment
timeFrame: baseline to 126 months
Secondary outcomes:
measure: Change in Glycosylated Hemoglobin by Duration of Exubera Treatment
timeFrame: Baseline to 126 months
measure: Hypoglycemic Event Rates by Interval of Exubera Treatment
timeFrame: 0 to 132 months
measure: Severe Hypoglycemic Event Rates by Interval of Exubera Treatment
timeFrame: 0-132 months
measure: Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes
timeFrame: 36 months to 126 months
measure: Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)
timeFrame: 36 to 126 months
measure: Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)
timeFrame: 6 to 120 months
measure: 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
timeFrame: 3 to >=108 months
measure: Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment
timeFrame: 3 to >=108 months
measure: Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment
timeFrame: 6 to >=108 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: