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

NCT00137046 | Terminated Phase 3 Results

• 1 other identifier: A2171022
• Study Type: interventional
• Target: 582
• Locations: 5 countries
• Sites: 73

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (6)

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

  Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation \[FEV1\] in liters \[L\] at observation minus Baseline value).

  Baseline through Extension Follow-up Month 3

• Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)

  Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % \[(baseline observed value minus visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed.

  Month 3 through Extension Follow-up 3

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

  Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity \[DLco\] measured in milliters/minutes/millimeters of mercury \[mL/min/mmHg\] at observation minus Baseline value).

  Baseline through Extension Follow-up Month 3

• Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).

  Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% \[(baseline observed value minus visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrent illness, a repeat DLco was performed.

  Month 3 through Extension Follow-up Month 3

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

  Annual rate of change in FEV1 calculated as slope over time \[visit\] for forced expiratory volume in 1 second measured as liters per year (L/yr).

  Week -2 through Extension Follow-up Month 6 or end of study

• Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)

  Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of hemoglobin per year (ml/min/mmHg/yr).

  Week -2 through Extension Follow-up Month 6 or end of study

Secondary Outcomes (16)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c)

  Baseline through Extension Follow-up Month 3

• Hypoglycemic Event Rates

  Month 1 through Extension Month 39

• Severe Hypoglycemic Event Rates

  Month 1 through Extension Month 39

• Change From Baseline in Fasting Plasma Glucose

  Baseline through Extension Follow-up Month 3

• Change From Baseline Body Weight

  Baseline through Extension Follow-up Month 3

Study Arms (2)

Subcutaneous Insulin

ACTIVE COMPARATOR

Drug: Subcutaneous Insulin

Inhaled Insulin

EXPERIMENTAL

Drug: Inhaled Insulin

Interventions

Subcutaneous Insulin DRUG

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Subcutaneous Insulin

Inhaled Insulin DRUG

Inhaled insulin with dose adjusted according to premeal blood glucose

Inhaled Insulin

Eligibility Criteria

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

You may qualify if:

• Type 1 diabetes mellitus

You may not qualify if:

• severe asthma or COPD
• smoking
• brittle diabetes

Sponsors & Collaborators

• Pfizer: lead

Study Sites (73)

Pfizer Investigational Site

Fullerton, California, 92835, United States

Location

Pfizer Investigational Site

Long Beach, California, 90806, United States

Location

Pfizer Investigational Site

Sacramento, California, 95816, United States

Location

Pfizer Investigational Site

San Diego, California, 92103, United States

Location

Pfizer Investigational Site

Santa Barbara, California, 93105, United States

Location

Pfizer Investigational Site

Santa Rosa, California, 95405, United States

Location

Pfizer Investigational Site

Tustin, California, 92780, United States

Location

Pfizer Investigational Site

Walnut Creek, California, 94598, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80220, United States

Location

Pfizer Investigational Site

Longmont, Colorado, 80501, United States

Location

Pfizer Investigational Site

Hamden, Connecticut, 06518, United States

Location

Pfizer Investigational Site

Madison, Connecticut, 06443, United States

Location

Pfizer Investigational Site

Newark, Delaware, 19713, United States

Location

Pfizer Investigational Site

Coral Gables, Florida, 33134, United States

Location

Pfizer Investigational Site

Hollywood, Florida, 33021, United States

Location

Pfizer Investigational Site

Miami, Florida, 33136, United States

Location

Pfizer Investigational Site

Tallahassee, Florida, 32308, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33401, United States

Location

Pfizer Investigational Site

Winter Park, Florida, 32789, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60602, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60610, United States

Location

Pfizer Investigational Site

Wilmette, Illinois, 60091, United States

Location

Pfizer Investigational Site

Bethesda, Maryland, 20817, 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

New Hyde Park, New York, 11042, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27713, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97210, United States

Location

Pfizer Investigational Site

Lansdale, Pennsylvania, 19446, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75246, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Burlington, Vermont, 05401, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23225, United States

Location

Pfizer Investigational Site

Renton, Washington, 98057, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53209, United States

Location

Pfizer Investigational Site

Capital Federal, Buenos Aires, C1120 AAF, Argentina

Location

Pfizer Investigational Site

Capital Federal, Buenos Aires, C1181 ACH, Argentina

Location

Pfizer Investigational Site

Capital Federal, Buenos Aires, C1405 DCS, Argentina

Location

Pfizer Investigational Site

Capital Federal, Buenos Aires, C1427 AQR, Argentina

Location

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Pfizer Investigational Site

Curitiba, Paraná, 80420-011, Brazil

Location

Pfizer Investigational Site

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

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-903, 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

São Paulo, São Paulo, 04020-041, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04231-030, Brazil

Location

Pfizer Investigational Site

Calgary, Alberta, T2T 5C7, Canada

Location

Pfizer Investigational Site

Calgary, Alberta, T3B 0M3, Canada

Location

Pfizer Investigational Site

Edmonton, Alberta, T5J 3N4, Canada

Location

Pfizer Investigational Site

Edmonton, Alberta, T6G 2C8, Canada

Location

Pfizer Investigational Site

Victoria, British Columbia, V8R 1J8, Canada

Location

Pfizer Investigational Site

Winnepeg, Manitoba, R3A 1R9, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Pfizer Investigational Site

Kingston, Ontario, K7L 2V7, Canada

Location

Pfizer Investigational Site

London, Ontario, N6A 4V2, Canada

Location

Pfizer Investigational Site

Mississauga, Ontario, L5M 2V8, Canada

Location

Pfizer Investigational Site

Oakville, Ontario, L6H 3P1, Canada

Location

Pfizer Investigational Site

Ottawa, Ontario, K1H 1A2, Canada

Location

Pfizer Investigational Site

Thornhill, Ontario, L4J 8L7, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M4R 2G4, Canada

Location

Pfizer Investigational Site

Laval, Quebec, H7T 2P5, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H1T 2M4, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3A 1A1, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Pfizer Investigational Site

Mexico City, COL LAS Americas, 01120, Mexico

Location

Pfizer Investigational Site

Mexico City, Mexico City, 02990, Mexico

Location

Pfizer Investigational Site

Mexico City, Mexico City, 14000, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64060, Mexico

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Due to early termination of study, none of the subjects completed the study as planned. Subjects active at the time of study termination completed an end-of-study assessment and a 3-month follow-up visit.

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 29, 2005
• Study Start: May 1, 2002
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 18, 2010
• Results First Posted: January 26, 2010

Record last verified: 2009-12

Locations

AR (4); US (36); BR (8); ME (4); CA (21)