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

NCT00138671 | Terminated Phase 3 Results

• 1 other identifier: A2171030
• Study Type: interventional
• Target: 105
• Locations: 5 countries
• Sites: 88

Brief Summary

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

Conditions

Diabetes Mellitus; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

  FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).

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

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

  DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).

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

Secondary Outcomes (21)

• Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)

  Duration of the study

• Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)

  Duration of the study

• Other PFTs (Besides FEV1 and DLco)

  Duration of the study

• Bronchodilator Responsiveness as Determined by the Change in FEV1

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

• Insulin Dose Responsiveness for FEV1

  Baseline, Week 9, Week 51

Study Arms (2)

Subcutaneous Insulin

ACTIVE COMPARATOR

Drug: Subcutaneous Insulin

Inhaled Insulin

EXPERIMENTAL

Drug: Inhaled Insulin

Interventions

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

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

Eligibility Criteria

• Age: 30 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
• Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC \< 70%) and FEV1 \< 80% predicted and/or a history of chronic productive cough.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (88)

Pfizer Investigational Site

Glendale, Arizona, 85306, United States

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Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85004, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85016, United States

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Tucson, Arizona, 85715, United States

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Jonesboro, Arkansas, 72401, United States

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Searcy, Arkansas, 72143, United States

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Berkeley, California, 94705, United States

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Fresno, California, 93720, United States

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Greenbrae, California, 94904, United States

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Huntington Beach, California, 92648, United States

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Los Angeles, California, 90073, United States

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Riverside, California, 92506, United States

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Tustin, California, 92780, United States

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Denver, Colorado, 80209, United States

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Waterbury, Connecticut, 06708, United States

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Chiefland, Florida, 32626, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33765, United States

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DeLand, Florida, 32720, United States

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Gainesville, Florida, 32608, United States

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Lake City, Florida, 32025, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33144, United States

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West Palm Beach, Florida, 33401, United States

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Winter Park, Florida, 32789, United States

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Decatur, Georgia, 30033, United States

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Honolulu, Hawaii, 96813, United States

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Honululu, Hawaii, 96814, United States

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Chicago, Illinois, 60607, United States

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Normal, Illinois, 61761, United States

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Evansville, Indiana, 47713-1227, United States

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Indianapolis, Indiana, 46250, United States

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Des Moines, Iowa, 50314, United States

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Wichita, Kansas, 67203, United States

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Madisonville, Kentucky, 42431, United States

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New Orleans, Louisiana, 70119, United States

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Springfield, Massachusetts, 01103, United States

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Springfield, Massachusetts, 01107, United States

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Waltham, Massachusetts, 02453, United States

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Kansas City, Missouri, 64106, United States

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St Louis, Missouri, 63141, United States

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Butte, Montana, 59701, United States

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Omaha, Nebraska, 68105, United States

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Henderson, Nevada, 89015, United States

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Las Vegas, Nevada, 89103, United States

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Las Vegas, Nevada, 89128, United States

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Albany, New York, 12205, United States

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Albany, New York, 12206, United States

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Cincinnati, Ohio, 45231, United States

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Cincinnati, Ohio, 45242, United States

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Toledo, Ohio, 43608, United States

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Oklahoma City, Oklahoma, 73103, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97219, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Spartanburg, South Carolina, 29303, United States

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Spartanburg, South Carolina, 29307, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37203, United States

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Beaumont, Texas, 77701, United States

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Beaumont, Texas, 77706, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78237, United States

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Fredericksburg, Virginia, 22401, United States

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Fredericksburg, Virginia, 22408, United States

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Richmond, Virginia, 23225, United States

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Richmond, Virginia, 23229, United States

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Richmond, Virginia, 23235, United States

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Richmond, Virginia, 23249, United States

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Spokane, Washington, 99202, United States

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Spokane, Washington, 99204, United States

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Huntington, West Virginia, 25701, United States

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Madison, Wisconsin, 53705, United States

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

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Campinas, São Paulo, 13083-900, Brazil

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São Paulo, São Paulo, 01244-030, Brazil

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São Paulo, São Paulo, 04231-030, Brazil

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Edmonton, Alberta, T5J 3N4, Canada

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Red Deer, Alberta, T4N 6V7, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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Laval, Quebec, H7T 2P5, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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San José, Provincia de San José, Costa Rica

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Neuss, 41460, Germany

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated due to Pfizer's decision to stop marketing Exubera®. Due to inconsistency in concomitant medication data entry, interpretation of the event rates for non-severe exacerbations may be of limited clinical value.

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 26, 2005
• First Posted: August 30, 2005
• Study Start: January 1, 2003
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 2, 2010
• Results First Posted: November 13, 2009

Record last verified: 2009-08

Locations

DE (1); US (77); CO (1); BR (4); CA (5)