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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137046
First received: August 26, 2005
Last updated: February 3, 2010
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Subcutaneous Insulin
Drug: Inhaled Insulin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline through Extension Follow-up Month 3 ] [ Designated as safety issue: Yes ]
  • Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Month 3 through Extension Follow-up 3 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Baseline through Extension Follow-up Month 3 ] [ Designated as safety issue: Yes ]
  • Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco). [ Time Frame: Month 3 through Extension Follow-up Month 3 ] [ Designated as safety issue: Yes ]
  • Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Week -2 through Extension Follow-up Month 6 or end of study ] [ Designated as safety issue: Yes ]
  • Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Week -2 through Extension Follow-up Month 6 or end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline through Extension Follow-up Month 3 ] [ Designated as safety issue: No ]
  • Hypoglycemic Event Rates [ Time Frame: Month 1 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Severe Hypoglycemic Event Rates [ Time Frame: Month 1 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose [ Time Frame: Baseline through Extension Follow-up Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline Body Weight [ Time Frame: Baseline through Extension Follow-up Month 3 ] [ Designated as safety issue: No ]
  • Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Month 3 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Total Daily Long-Acting Insulin Dose Adjusted for Body Weight [ Time Frame: Month 3 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Month 3 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Total Daily Short-Acting Insulin Dose Adjusted for Body Weight [ Time Frame: Month 3 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Baseline Dyspnea Index (BDI) [ Time Frame: Week - 1 ] [ Designated as safety issue: Yes ]
  • Transition Dyspnea Index (TDI) [ Time Frame: Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study ] [ Designated as safety issue: Yes ]
  • Lipids [ Time Frame: Week -4 through Month 24 ] [ Designated as safety issue: No ]
  • Cough Questionnaire [ Time Frame: Week 0 and if indicated through Extension Follow up Month 3 ] [ Designated as safety issue: No ]
  • Forced Vital Capacity (FVC) [ Time Frame: Week -3 through Extension Follow-up Month 6 or End of Study ] [ Designated as safety issue: Yes ]
  • Total Lung Capacity (TLC) [ Time Frame: Week -3 through Extension Follow-up Month 6 or End of Study ] [ Designated as safety issue: Yes ]
  • Insulin Antibodies [ Time Frame: Baseline through Extension Month 39 ] [ Designated as safety issue: Yes ]

Enrollment: 582
Study Start Date: May 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subcutaneous Insulin Drug: Subcutaneous Insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose
Experimental: Inhaled Insulin Drug: Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  • severe asthma or COPD
  • smoking
  • brittle diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137046

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Fullerton, California, United States, 92835
Pfizer Investigational Site
Long Beach, California, United States, 90806
Pfizer Investigational Site
Sacramento, California, United States, 95816
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
Santa Barbara, California, United States, 93105
Pfizer Investigational Site
Santa Rosa, California, United States, 95405
Pfizer Investigational Site
Tustin, California, United States, 92780
Pfizer Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80220
Pfizer Investigational Site
Longmont, Colorado, United States, 80501
United States, Connecticut
Pfizer Investigational Site
Hamden, Connecticut, United States, 06518
Pfizer Investigational Site
Madison, Connecticut, United States, 06443
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
Pfizer Investigational Site
Coral Gables, Florida, United States, 33134
Pfizer Investigational Site
Hollywood, Florida, United States, 33021
Pfizer Investigational Site
Miami, Florida, United States, 33136
Pfizer Investigational Site
Tallahassee, Florida, United States, 32308
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33401
Pfizer Investigational Site
Winter Park, Florida, United States, 32789
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60602
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
Pfizer Investigational Site
Wilmette, Illinois, United States, 60091
United States, Maryland
Pfizer Investigational Site
Bethesda, Maryland, United States, 20817
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Montana
Pfizer Investigational Site
Butte, Montana, United States, 59701
United States, New York
Pfizer Investigational Site
New Hyde Park, New York, United States, 11042
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27713
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pfizer Investigational Site
Lansdale, Pennsylvania, United States, 19446
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Vermont
Pfizer Investigational Site
Burlington, Vermont, United States, 05401
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23225
United States, Washington
Pfizer Investigational Site
Renton, Washington, United States, 98057
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Argentina
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, C1427 AQR
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, C1120 AAF
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, C1405 DCS
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, C1181 ACH
Brazil
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30150-221
Pfizer Investigational Site
Curitiba, PR, Brazil, 80420-011
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-170
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-903
Pfizer Investigational Site
Campinas, SP, Brazil, 13083-900
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01244-030
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04231-030
Pfizer Investigational Site
São Paulo, SP, Brazil, 04020-041
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T3B 0M3
Pfizer Investigational Site
Calgary, Alberta, Canada, T2T 5C7
Pfizer Investigational Site
Edmonton, Alberta, Canada, T5J 3N4
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Pfizer Investigational Site
Victoria, British Columbia, Canada, V8R 1J8
Canada, Manitoba
Pfizer Investigational Site
Winnepeg, Manitoba, Canada, R3A 1R9
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Pfizer Investigational Site
Kingston, Ontario, Canada, K7L 2V7
Pfizer Investigational Site
London, Ontario, Canada, N6A 4V2
Pfizer Investigational Site
Mississauga, Ontario, Canada, L5M 2V8
Pfizer Investigational Site
Oakville, Ontario, Canada, L6H 3P1
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1H 1A2
Pfizer Investigational Site
Thornhill, Ontario, Canada, L4J 8L7
Pfizer Investigational Site
Toronto, Ontario, Canada, M4R 2G4
Canada, Quebec
Pfizer Investigational Site
Laval, Quebec, Canada, H7T 2P5
Pfizer Investigational Site
Montreal, Quebec, Canada, H3A 1A1
Pfizer Investigational Site
Montreal, Quebec, Canada, H1T 2M4
Pfizer Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 0W8
Mexico
Pfizer Investigational Site
Mexico Df, Col Las Americas, Mexico, 01120
Pfizer Investigational Site
Mexico, DF, Mexico, 14000
Pfizer Investigational Site
Mexico, DF, Mexico, 02990
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64060
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00137046     History of Changes
Other Study ID Numbers: A2171022
Study First Received: August 26, 2005
Results First Received: December 7, 2009
Last Updated: February 3, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014