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

NCT00139659 | Completed Phase 3 Results

• 1 other identifier: A2171028
• Study Type: interventional
• Target: 288
• Locations: 5 countries
• Sites: 102

Brief Summary

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma

Conditions

Asthma; Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)

  Annualized rates of change (slope throughout time from baseline to end of study\[visit\]) for forced expiratory volume in 1 second (FEV1) (liters per year \[L/yr\]) measured 30 minutes following the administration of albuterol.

  Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52

• Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)

  Annualized rates of change (slope throughout time from baseline to end of study\[visit\]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol.

  Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52

• Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)

  Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value.

  Baseline through Week 52 Last Observation Carried Forward (LOCF)

• Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)

  Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value.

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)

Secondary Outcomes (32)

• Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)

  Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)

• Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF)

• Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)

  Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward

• Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)

  Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)

• Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)

Study Arms (2)

Inhaled Insulin

EXPERIMENTAL

Drug: Inhaled Insulin

Subcutaneous Insulin

ACTIVE COMPARATOR

Drug: Subcutaneous Insulin

Interventions

Inhaled Insulin DRUG

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.

Inhaled Insulin

Subcutaneous Insulin DRUG

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.

Subcutaneous Insulin

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
• Mild intermittent or mild to moderate persistent asthma

You may not qualify if:

• Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking

Sponsors & Collaborators

• Pfizer: lead

Study Sites (102)

Pfizer Investigational Site

Glendale, Arizona, 85306, United States

Location

Pfizer Investigational Site

Peoria, Arizona, 85381, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85004, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85006, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85016, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85715, United States

Location

Pfizer Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

Pfizer Investigational Site

Searcy, Arkansas, 72143, United States

Location

Pfizer Investigational Site

Berkeley, California, 94705, United States

Location

Pfizer Investigational Site

Beverly Hills, California, 90211, United States

Location

Pfizer Investigational Site

Fresno, California, 93720, United States

Location

Pfizer Investigational Site

Greenbrae, California, 94904, United States

Location

Pfizer Investigational Site

Huntington Beach, California, 92648, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90073, United States

Location

Pfizer Investigational Site

Riverside, California, 92506, United States

Location

Pfizer Investigational Site

San Diego, California, 92114, United States

Location

Pfizer Investigational Site

San Diego, California, 92116, United States

Location

Pfizer Investigational Site

Tustin, California, 92780, United States

Location

Pfizer Investigational Site

Boulder, Colorado, 80304, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80206, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80209, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80220, United States

Location

Pfizer Investigational Site

Waterbury, Connecticut, 06708, United States

Location

Pfizer Investigational Site

Newark, Delaware, 19713, United States

Location

Pfizer Investigational Site

Chiefland, Florida, 32626, United States

Location

Pfizer Investigational Site

Clearwater, Florida, 33756, United States

Location

Pfizer Investigational Site

Clearwater, Florida, 33765, United States

Location

Pfizer Investigational Site

Melbourne, Florida, 32901, United States

Location

Pfizer Investigational Site

Miami, Florida, 33144, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33401, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33404, United States

Location

Pfizer Investigational Site

Augusta, Georgia, 30909, United States

Location

Pfizer Investigational Site

Honolulu, Hawaii, 96813, United States

Location

Pfizer Investigational Site

Honululu, Hawaii, 96814, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60611, United States

Location

Pfizer Investigational Site

Normal, Illinois, 61761, United States

Location

Pfizer Investigational Site

Evansville, Indiana, 47713, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46250, United States

Location

Pfizer Investigational Site

Des Moines, Iowa, 50314, United States

Location

Pfizer Investigational Site

Dubuque, Iowa, 52001, United States

Location

Pfizer Investigational Site

Dubuque, Iowa, 52002, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67203, United States

Location

Pfizer Investigational Site

Bossier City, Louisiana, 71111, United States

Location

Pfizer Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01103, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01107, United States

Location

Pfizer Investigational Site

Waltham, Massachusetts, 02453, United States

Location

Pfizer Investigational Site

Brooklyn Center, Minnesota, 55430, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63141, United States

Location

Pfizer Investigational Site

Butte, Montana, 59701, United States

Location

Pfizer Investigational Site

Henderson, Nevada, 89015, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89103, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89128, United States

Location

Pfizer Investigational Site

North Las Vegas, Nevada, 89032, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87131-5666, United States

Location

Pfizer Investigational Site

Buffalo, New York, 14209, United States

Location

Pfizer Investigational Site

New York, New York, 10029, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45231, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45242, United States

Location

Pfizer Investigational Site

Dayton, Ohio, 45402, United States

Location

Pfizer Investigational Site

Toledo, Ohio, 43606, United States

Location

Pfizer Investigational Site

Toledo, Ohio, 43608, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Pfizer Investigational Site

Medford, Oregon, 97504, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97210, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97219, United States

Location

Pfizer Investigational Site

Lansdale, Pennsylvania, 19446, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15243, United States

Location

Pfizer Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

Pfizer Investigational Site

Spartanburg, South Carolina, 29307, United States

Location

Pfizer Investigational Site

Bartlett, Tennessee, 38133, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38119, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

Beaumont, Texas, 77701, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

Houstan, Texas, 77079, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Houston, Texas, 77043, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78237, United States

Location

Pfizer Investigational Site

Norfolk, Virginia, 23502, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23229, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23235, United States

Location

Pfizer Investigational Site

Spokane, Washington, 99202, United States

Location

Pfizer Investigational Site

Spokane, Washington, 99204, United States

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-170, Brazil

Location

Pfizer Investigational Site

Campinas, São Paulo, 13083-900, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01244-030, Brazil

Location

Pfizer Investigational Site

SP, São Paulo, 04231-030, Brazil

Location

Pfizer Investigational Site

Edmonton, Alberta, T5J 3N4, Canada

Location

Pfizer Investigational Site

Red Deer, Alberta, T4N 6V7, Canada

Location

Pfizer Investigational Site

Victoria, British Columbia, V8R 1J8, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Pfizer Investigational Site

Burlington, Ontario, L7M 4Y1, Canada

Location

Pfizer Investigational Site

London, Ontario, N6A 4V2, Canada

Location

Pfizer Investigational Site

Laval, Quebec, H7T 2P5, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H1T 2M4, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Pfizer Investigational Site

San José, Provincia de San José, Costa Rica

Location

Pfizer Investigational Site

Neuss, 41460, Germany

Location

Related Links

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

MeSH Terms

Conditions

Asthma; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Data for some secondary endpoints were not tabulated or analyzed for this study and some concomitant medication data were not accurately recorded and tabulated due to lack of resources resulting from scaling down of Exubera® development.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 31, 2005
• Study Start: January 1, 2003
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 2, 2010
• Results First Posted: May 12, 2010

Record last verified: 2009-10

Locations

CA (10); BR (4); DE (1); US (86); CO (1)