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NCT00137046 Clinical Trial

Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00137046
Other study ID # A2171022
Secondary ID
Status Terminated
Phase Phase 3
First received August 26, 2005
Last updated February 3, 2010
Start date May 2002
Est. completion date December 2008

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

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 582
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Type 1 diabetes mellitus

Exclusion Criteria:

- severe asthma or COPD

- smoking

- brittle diabetes

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 insulin with dose adjusted according to premeal blood glucose
• Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose

Locations
Country Name City State
Argentina Pfizer Investigational Site Capital Federal Buenos Aires
Argentina Pfizer Investigational Site Capital Federal Buenos Aires
Argentina Pfizer Investigational Site Capital Federal Buenos Aires
Argentina Pfizer Investigational Site Capital Federal Buenos Aires
Brazil Pfizer Investigational Site Belo Horizonte MG
Brazil Pfizer Investigational Site Campinas SP
Brazil Pfizer Investigational Site Curitiba PR
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Sao Paulo SP
Brazil Pfizer Investigational Site Sao Paulo SP
Brazil Pfizer Investigational Site São Paulo SP
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Kingston Ontario
Canada Pfizer Investigational Site Laval Quebec
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site Mississauga Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Oakville Ontario
Canada Pfizer Investigational Site Ottawa Ontario
Canada Pfizer Investigational Site Saskatoon Saskatchewan
Canada Pfizer Investigational Site Sherbrooke Quebec
Canada Pfizer Investigational Site Thornhill Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Victoria British Columbia
Canada Pfizer Investigational Site Winnepeg Manitoba
Canada Pfizer Investigational Site Winnipeg Manitoba
Mexico Pfizer Investigational Site Mexico DF
Mexico Pfizer Investigational Site Mexico DF
Mexico Pfizer Investigational Site Mexico Df Col Las Americas
Mexico Pfizer Investigational Site Monterrey Nuevo Leon
United States Pfizer Investigational Site Bethesda Maryland
United States Pfizer Investigational Site Burlington Vermont
United States Pfizer Investigational Site Butte Montana
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Coral Gables Florida
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Fullerton California
United States Pfizer Investigational Site Hamden Connecticut
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Lansdale Pennsylvania
United States Pfizer Investigational Site Long Beach California
United States Pfizer Investigational Site Longmont Colorado
United States Pfizer Investigational Site Madison Connecticut
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site New Hyde Park New York
United States Pfizer Investigational Site Newark Delaware
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Renton Washington
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Santa Barbara California
United States Pfizer Investigational Site Santa Rosa California
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site Tallahassee Florida
United States Pfizer Investigational Site Tustin California
United States Pfizer Investigational Site Walnut Creek California
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site Wilmette Illinois
United States Pfizer Investigational Site Winter Park Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Baseline through Extension Follow-up Month 3 Yes
Primary Summary of = 15% Decliners in Forced Expiratory Volume in One Second (FEV1) Month 3 through Extension Follow-up 3 Yes
Primary Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) Baseline through Extension Follow-up Month 3 Yes
Primary Summary of = 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco). Month 3 through Extension Follow-up Month 3 Yes
Primary Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1) Week -2 through Extension Follow-up Month 6 or end of study Yes
Primary Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) Week -2 through Extension Follow-up Month 6 or end of study Yes
Secondary Change From Baseline in Glycosylated Hemoglobin (HbA1c) Baseline through Extension Follow-up Month 3 No
Secondary Hypoglycemic Event Rates Month 1 through Extension Month 39 No
Secondary Severe Hypoglycemic Event Rates Month 1 through Extension Month 39 No
Secondary Change From Baseline in Fasting Plasma Glucose Baseline through Extension Follow-up Month 3 No
Secondary Change From Baseline Body Weight Baseline through Extension Follow-up Month 3 No
Secondary Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight) Month 3 through Extension Month 39 No
Secondary Total Daily Long-Acting Insulin Dose Adjusted for Body Weight Month 3 through Extension Month 39 No
Secondary Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight) Month 3 through Extension Month 39 No
Secondary Total Daily Short-Acting Insulin Dose Adjusted for Body Weight Month 3 through Extension Month 39 No
Secondary Baseline Dyspnea Index (BDI) Week - 1 Yes
Secondary Transition Dyspnea Index (TDI) Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study Yes
Secondary Lipids Week -4 through Month 24 No
Secondary Cough Questionnaire Week 0 and if indicated through Extension Follow up Month 3 No
Secondary Forced Vital Capacity (FVC) Week -3 through Extension Follow-up Month 6 or End of Study Yes
Secondary Total Lung Capacity (TLC) Week -3 through Extension Follow-up Month 6 or End of Study Yes
Secondary Insulin Antibodies Baseline through Extension Month 39 Yes
See also
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Completed NCT04530292 - Home Intervention and Social Precariousness in Childhood Diabetes N/A
Completed NCT05428943 - OPT101 in Type 1 Diabetes Patients Phase 1
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