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NCT00138671 Clinical Trial

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00138671
Other study ID # A2171030
Secondary ID
Status Terminated
Phase Phase 3
First received August 26, 2005
Last updated January 25, 2010
Start date January 2003
Est. completion date September 2008

Study information
Verified date August 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 105
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 77 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Subcutaneous Insulin
Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.
• Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.

Locations
Country Name City State
Brazil Pfizer Investigational Site Campinas SP
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Sao Paulo SP
Brazil Pfizer Investigational Site São Paulo SP
Canada Pfizer Investigational Site Burlington Ontario
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Laval Quebec
Canada Pfizer Investigational Site Red Deer Alberta
Canada Pfizer Investigational Site Sherbrooke Quebec
Costa Rica Pfizer Investigational Site San Jose
Germany Pfizer Investigational Site Neuss
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Beaumont Texas
United States Pfizer Investigational Site Beaumont Texas
United States Pfizer Investigational Site Berkeley California
United States Pfizer Investigational Site Butte Montana
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chiefland Florida
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site DeLand Florida
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Des Moines Iowa
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Fredericksburg Virginia
United States Pfizer Investigational Site Fredericksburg Virginia
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Glendale Arizona
United States Pfizer Investigational Site Greenbrae California
United States Pfizer Investigational Site Henderson Nevada
United States Pfizer Investigational Site Honolulu Hawaii
United States Pfizer Investigational Site Honululu Hawaii
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Huntington West Virginia
United States Pfizer Investigational Site Huntington Beach California
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jonesboro Arkansas
United States Pfizer Investigational Site Kansas City Missouri
United States Pfizer Investigational Site Lake City Florida
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Madisonville Kentucky
United States Pfizer Investigational Site Medford Oregon
United States Pfizer Investigational Site Melbourne Florida
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Normal Illinois
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Peoria Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Riverside California
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Searcy Arkansas
United States Pfizer Investigational Site Spartanburg South Carolina
United States Pfizer Investigational Site Spartanburg South Carolina
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site Toledo Ohio
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tustin California
United States Pfizer Investigational Site Waltham Massachusetts
United States Pfizer Investigational Site Waterbury Connecticut
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Winter Park Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Costa Rica,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 Yes
Primary Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco) Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 Yes
Secondary Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs) Duration of the study No
Secondary Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs) Duration of the study No
Secondary Other PFTs (Besides FEV1 and DLco) Duration of the study No
Secondary Bronchodilator Responsiveness as Determined by the Change in FEV1 Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 Yes
Secondary Insulin Dose Responsiveness for FEV1 Baseline, Week 9, Week 51 Yes
Secondary Insulin Dose Responsiveness for DLco Baseline, Week 9, Week 51 Yes
Secondary Methacholine PC20 Duration of the study No
Secondary Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used Duration of the study No
Secondary Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations 0 to 1 week to > 9 months Yes
Secondary Incidence of Severe COPD Exacerbations 0 to 1 week to > 9 months Yes
Secondary Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires Duration of the study No
Secondary Change From Baseline in Glycosylated Hemoglobin (HbA1c) Baseline, Weeks 6, 12, 26, 39, and 52 No
Secondary Change From Baseline in Fasting Plasma Glucose Baseline, Weeks 6, 12, 26, 39, 52 No
Secondary Change From Baseline in Body Weight Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52 No
Secondary Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight) Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 No
Secondary Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight) Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 No
Secondary Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight) Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 No
Secondary Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight) Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 No
Secondary Lipids Duration of the study No
Secondary Hypoglycemic Event Rates 0 to1 month to > 11 months No
Secondary Severe Hypoglcyemic Event Rates 0 to 1 month to > 11 months No
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