Clinical trial NCT00136916: Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes
Official title: Efficacy and Safety of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 2 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 635
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
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 inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.

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 A2171029 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus

Exclusion Criteria:

* COPD
* Asthma
* Smoking Pregnancy

Primary outcomes:
measure: Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Month 3 through extension Month 60
measure: Change From Baseline in FEV1
timeFrame: Baseline through extension follow up Month 3
measure: Annual Rate of Change in FEV1
timeFrame: Week -2 through extension follow up Month 3 or end of study
measure: Summary of ≥ 15 % Decliners in FEV1
timeFrame: Month 3 through extension follow up Month 3
measure: Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)
timeFrame: Week -2 through extension follow up Month 3 or end of study
measure: Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
timeFrame: Baseline through extension follow up Month 3
measure: Summary of ≥ 20 % Decliners in DLco
timeFrame: Month 3 through extension follow up Month 3
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Week -3 through extension follow up Month 3 or end of study
measure: Total Lung Capacity (TLC)
timeFrame: Baseline through extension follow up Month 3
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline through extension follow up Month 3
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Baseline through extension follow up Month 3
measure: Change From Baseline in 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 36
measure: Total Daily Long-acting Insulin (Adjusted for Body Weight)
timeFrame: Month 3 through extension Month 36
measure: Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
timeFrame: Month 3 through extension Month 36
measure: Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
timeFrame: Month 3 through extension Month 36
measure: Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides
timeFrame: Week -4 through Month 24
measure: Hypoglycemic Event Rates
timeFrame: Month 1 through extension Month 36
measure: Severe Hypoglycemic Event Rates
timeFrame: Month 1 through extension Month 36
measure: Cough Questionnaire
timeFrame: Week 0 and if indicated through extension follow up Month 3
measure: Baseline Dyspnea Index (BDI)
timeFrame: Week -1
measure: Transition Dyspnea Index (TDI)
timeFrame: Week 4 through extension follow up Month 3 or end of study
measure: High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
timeFrame: Baseline, M12, M24, Ext M6, Ext M18, Ext M36
measure: High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
timeFrame: Baseline, M12, M24, Ext M6, Ext M18, Ext M36
measure: Insulin Antibodies
timeFrame: Baseline through extension Month 36
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Greenbrae
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
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: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Luis Obispo
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: Hamden
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: Pfizer Investigational Site
state: Connecticut
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: Fort Myers
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: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
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: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Wilmette
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Bloomfield Hills
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Plymouth
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Royal Oak
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Southfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Chesterfield
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: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Mineola
country: United States
facility: Pfizer Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
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: Mansfield
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Corpus Christi
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: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Irving
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: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Sao 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: Red Deer
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: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
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: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Aguas Buenas
country: Puerto Rico
facility: Pfizer Investigational Site
city: Anasco
country: Puerto Rico
facility: Pfizer Investigational Site
city: Cabo Rojo
country: Puerto Rico
facility: Pfizer Investigational Site
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Rosenstock J, Cefalu WT, Hollander PA, Klioze SS, Reis J, Duggan WT. Safety and efficacy of inhaled human insulin (exubera) during discontinuation and readministration of therapy in adults with type 2 diabetes: a 3-year randomized controlled trial. Diabetes Technol Ther. 2009 Nov;11(11):697-705. doi: 10.1089/dia.2009.0062.
citation: Rosenstock J, Cefalu WT, Hollander PA, Belanger A, Eliaschewitz FG, Gross JL, Klioze SS, St Aubin LB, Foyt H, Ogawa M, Duggan WT. Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes. Diabetes Care. 2008 Sep;31(9):1723-8. doi: 10.2337/dc08-0159. Epub 2008 Jun 5.