Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00136916
• Other study ID #: A2171029
• Status: Terminated
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: February 12, 2010
• Start date: June 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 635
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus

Exclusion Criteria:

• COPD

• Asthma

• Smoking Pregnancy

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Laval	Quebec
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Red Deer	Alberta
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Toronto	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
Puerto Rico	Pfizer Investigational Site	Aguas Buenas
Puerto Rico	Pfizer Investigational Site	Anasco
Puerto Rico	Pfizer Investigational Site	Cabo Rojo
Puerto Rico	Pfizer Investigational Site	San Juan
Puerto Rico	Pfizer Investigational Site	San Juan
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Bethesda	Maryland
United States	Pfizer Investigational Site	Bloomfield Hills	Michigan
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Burlington	Vermont
United States	Pfizer Investigational Site	Butte	Montana
United States	Pfizer Investigational Site	Chesterfield	Missouri
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chiefland	Florida
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Corpus Christi	Texas
United States	Pfizer Investigational Site	Corpus Christi	Texas
United States	Pfizer Investigational Site	Dallas	Texas
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	Fort Myers	Florida
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Greenbrae	California
United States	Pfizer Investigational Site	Hamden	Connecticut
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Irving	Texas
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Madison	Connecticut
United States	Pfizer Investigational Site	Mansfield	Ohio
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Mineola	New York
United States	Pfizer Investigational Site	New Britain	Connecticut
United States	Pfizer Investigational Site	New Hyde Park	New York
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Palm Harbor	Florida
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Plymouth	Michigan
United States	Pfizer Investigational Site	Renton	Washington
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Royal Oak	Michigan
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	San Diego	California
United States	Pfizer Investigational Site	San Luis Obispo	California
United States	Pfizer Investigational Site	Southfield	Michigan
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Tallahassee	Florida
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tustin	California
United States	Pfizer Investigational Site	Walnut Creek	California
United States	Pfizer Investigational Site	Warwick	Rhode Island
United States	Pfizer Investigational Site	Waterbury	Connecticut
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Wilmette	Illinois
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)		Month 3 through extension Month 60	Yes
Primary	Change From Baseline in FEV1		Baseline through extension follow up Month 3	Yes
Primary	Annual Rate of Change in FEV1		Week -2 through extension follow up Month 3 or end of study	Yes
Primary	Summary of = 15 % Decliners in FEV1		Month 3 through extension follow up Month 3	Yes
Primary	Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)		Week -2 through extension follow up Month 3 or end of study	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 DLco		Month 3 through extension follow up Month 3	Yes
Secondary	Forced Vital Capacity (FVC)		Week -3 through extension follow up Month 3 or end of study	Yes
Secondary	Total Lung Capacity (TLC)		Baseline through extension follow up Month 3	Yes
Secondary	Change From Baseline in Glycosylated Hemoglobin (HbA1c)		Baseline through extension follow up Month 3	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG)		Baseline through extension follow up Month 3	No
Secondary	Change From Baseline in 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 36	No
Secondary	Total Daily Long-acting Insulin (Adjusted for Body Weight)		Month 3 through extension Month 36	No
Secondary	Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)		Month 3 through extension Month 36	No
Secondary	Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)		Month 3 through extension Month 36	No
Secondary	Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides		Week -4 through Month 24	No
Secondary	Hypoglycemic Event Rates		Month 1 through extension Month 36	No
Secondary	Severe Hypoglycemic Event Rates		Month 1 through extension Month 36	No
Secondary	Cough Questionnaire		Week 0 and if indicated through extension follow up Month 3	No
Secondary	Baseline Dyspnea Index (BDI)		Week -1	Yes
Secondary	Transition Dyspnea Index (TDI)		Week 4 through extension follow up Month 3 or end of study	Yes
Secondary	High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits		Baseline, M12, M24, Ext M6, Ext M18, Ext M36	Yes
Secondary	High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits		Baseline, M12, M24, Ext M6, Ext M18, Ext M36	Yes
Secondary	Insulin Antibodies		Baseline through extension Month 36	Yes

External Links

•   To obtain contact information for a study center near you, click here.