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

NCT ID: NCT00136916

Last Updated: 2010-02-18

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

635 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inhaled Insulin

Inhalable short-acting insulin

Group Type EXPERIMENTAL

Inhaled Insulin

Intervention Type DRUG

Inhaled insulin with dose adjusted according to premeal blood glucose

Subcutaneous insulin

Group Type ACTIVE_COMPARATOR

Subcutaneous insulin

Intervention Type DRUG

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Interventions

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Inhaled Insulin

Inhaled insulin with dose adjusted according to premeal blood glucose

Intervention Type DRUG

Subcutaneous insulin

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Intervention Type DRUG

Other Intervention Names

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Exubera

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus

Exclusion Criteria

* COPD
* Asthma
* Smoking Pregnancy
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Fresno, California, United States

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Greenbrae, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Luis Obispo, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Hamden, Connecticut, United States

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Madison, Connecticut, United States

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New Britain, Connecticut, United States

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Waterbury, Connecticut, United States

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Chiefland, Florida, United States

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Clearwater, Florida, United States

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Fort Myers, Florida, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Palm Harbor, Florida, United States

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Tallahassee, Florida, United States

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West Palm Beach, Florida, United States

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Honolulu, Hawaii, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Springfield, Illinois, United States

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Wilmette, Illinois, United States

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New Orleans, Louisiana, United States

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Bethesda, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Bloomfield Hills, Michigan, United States

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Plymouth, Michigan, United States

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Royal Oak, Michigan, United States

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Southfield, Michigan, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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Lincoln, Nebraska, United States

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Henderson, Nevada, United States

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Albuquerque, New Mexico, United States

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Albuquerque, New Mexico, United States

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Mineola, New York, United States

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New Hyde Park, New York, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Mansfield, Ohio, United States

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Tulsa, Oklahoma, United States

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Warwick, Rhode Island, United States

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Beaumont, Texas, United States

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Beaumont, Texas, United States

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Corpus Christi, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Burlington, Vermont, United States

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Richmond, Virginia, United States

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Renton, Washington, United States

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Milwaukee, Wisconsin, United States

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Red Deer, Alberta, Canada

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Victoria, British Columbia, Canada

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Winnepeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Aguas Buenas, , Puerto Rico

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Añasco, , Puerto Rico

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Cabo Rojo, , Puerto Rico

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San Juan, , Puerto Rico

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San Juan, , Puerto Rico

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Countries

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United States Brazil Canada Puerto Rico

References

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Rosenstock J, Cefalu WT, Hollander PA, Klioze SS, Reis J, Duggan WT. Safety and efficacy of inhaled human insulin (exubera) during discontinuation and readministration of therapy in adults with type 2 diabetes: a 3-year randomized controlled trial. Diabetes Technol Ther. 2009 Nov;11(11):697-705. doi: 10.1089/dia.2009.0062.

Reference Type DERIVED
PMID: 19905885 (View on PubMed)

Rosenstock J, Cefalu WT, Hollander PA, Belanger A, Eliaschewitz FG, Gross JL, Klioze SS, St Aubin LB, Foyt H, Ogawa M, Duggan WT. Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes. Diabetes Care. 2008 Sep;31(9):1723-8. doi: 10.2337/dc08-0159. Epub 2008 Jun 5.

Reference Type DERIVED
PMID: 18535196 (View on PubMed)

Related Links

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Other Identifiers

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A2171029

Identifier Type: -

Identifier Source: org_study_id

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