Clinical trial NCT00137046: Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
Official title: Efficacy and Safety of Exubera (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 1 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

Detailed description: Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171022 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus

Exclusion Criteria:

* severe asthma or COPD
* smoking
* brittle diabetes

Primary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline through Extension Follow-up Month 3
measure: Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Month 3 through Extension Follow-up 3
measure: Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
timeFrame: Baseline through Extension Follow-up Month 3
measure: Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
timeFrame: Month 3 through Extension Follow-up Month 3
measure: Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Week -2 through Extension Follow-up Month 6 or end of study
measure: Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)
timeFrame: Week -2 through Extension Follow-up Month 6 or end of study
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline through Extension Follow-up Month 3
measure: Hypoglycemic Event Rates
timeFrame: Month 1 through Extension Month 39
measure: Severe Hypoglycemic Event Rates
timeFrame: Month 1 through Extension Month 39
measure: Change From Baseline in Fasting Plasma Glucose
timeFrame: Baseline through Extension Follow-up Month 3
measure: Change From Baseline Body Weight
timeFrame: Baseline through Extension Follow-up Month 3
measure: Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
timeFrame: Month 3 through Extension Month 39
measure: Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
timeFrame: Month 3 through Extension Month 39
measure: Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
timeFrame: Month 3 through Extension Month 39
measure: Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
timeFrame: Month 3 through Extension Month 39
measure: Baseline Dyspnea Index (BDI)
timeFrame: Week - 1
measure: Transition Dyspnea Index (TDI)
timeFrame: Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study
measure: Lipids
timeFrame: Week -4 through Month 24
measure: Cough Questionnaire
timeFrame: Week 0 and if indicated through Extension Follow up Month 3
measure: Forced Vital Capacity (FVC)
timeFrame: Week -3 through Extension Follow-up Month 6 or End of Study
measure: Total Lung Capacity (TLC)
timeFrame: Week -3 through Extension Follow-up Month 6 or End of Study
measure: Insulin Antibodies
timeFrame: Baseline through Extension Month 39
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Barbara
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Rosa
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Longmont
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Hamden
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Coral Gables
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Wilmette
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Butte
country: United States
facility: Pfizer Investigational Site
state: Montana
city: New Hyde Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Lansdale
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
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
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Campinas
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnepeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Mexico Df
country: Mexico
facility: Pfizer Investigational Site
state: Col Las Americas
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: