Clinical trial NCT00138671: A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD
Official title: Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Obstructive Pulmonary Disease: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus
Chronic Obstructive Pulmonary Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 105
Sex: ALL
Minimum age (years): 30
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.

Detailed description: Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for study A2171030 was placed on hold. 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 A2171030 was terminated on June 17, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
* Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC \< 70%) and FEV1 \< 80% predicted and/or a history of chronic productive cough.

Exclusion Criteria:

* Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active smoking

Primary outcomes:
measure: Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52
measure: Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)
timeFrame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52
Secondary outcomes:
measure: Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)
timeFrame: Duration of the study
measure: Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)
timeFrame: Duration of the study
measure: Other PFTs (Besides FEV1 and DLco)
timeFrame: Duration of the study
measure: Bronchodilator Responsiveness as Determined by the Change in FEV1
timeFrame: Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52
measure: Insulin Dose Responsiveness for FEV1
timeFrame: Baseline, Week 9, Week 51
measure: Insulin Dose Responsiveness for DLco
timeFrame: Baseline, Week 9, Week 51
measure: Methacholine PC20
timeFrame: Duration of the study
measure: Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used
timeFrame: Duration of the study
measure: Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
timeFrame: 0 to 1 week to > 9 months
measure: Incidence of Severe COPD Exacerbations
timeFrame: 0 to 1 week to > 9 months
measure: Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires
timeFrame: Duration of the study
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, Weeks 6, 12, 26, 39, and 52
measure: Change From Baseline in Fasting Plasma Glucose
timeFrame: Baseline, Weeks 6, 12, 26, 39, 52
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52
measure: Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)
timeFrame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52
measure: Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
timeFrame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52
measure: Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)
timeFrame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52
measure: Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight)
timeFrame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52
measure: Lipids
timeFrame: Duration of the study
measure: Hypoglycemic Event Rates
timeFrame: 0 to1 month to > 11 months
measure: Severe Hypoglcyemic Event Rates
timeFrame: 0 to 1 month to > 11 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Searcy
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Berkeley
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Greenbrae
country: United States
facility: Pfizer Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Riverside
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Chiefland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
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: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Honululu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Normal
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Waltham
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Butte
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fredericksburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Fredericksburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Huntington
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
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: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Burlington
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Neuss
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: