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

NCT00136916 | Terminated Phase 3 Results

• 1 other identifier: A2171029
• Study Type: interventional
• Target: 635
• Locations: 4 countries
• Sites: 92

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (7)

• Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)

  Change from Month 3: mean of (value of observed FEV1 \[forced expiratory volume in the first second of forced exhalation\] in liters \[L\] at treatment observation minus Month 3 value).

  Month 3 through extension Month 60

• Change From Baseline in FEV1

  Change from baseline: mean of (value of observed FEV1 \[L\] at treatment observation minus baseline value).

  Baseline through extension follow up Month 3

• Annual Rate of Change in 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 3 or end of study

• Summary of ≥ 15 % Decliners in FEV1

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

  Month 3 through extension follow up Month 3

• 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 mercury per year (ml/min/mmHg/yr).

  Week -2 through extension follow up Month 3 or end of study

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

  Change from baseline: mean of (value of observed DLco \[milliliters per minute per millimeters of mercury (ml/min/mmHg)\] at treatment observation minus baseline value).

  Baseline through extension follow up Month 3

• Summary of ≥ 20 % Decliners in DLco

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

  Month 3 through extension follow up Month 3

Secondary Outcomes (18)

• Forced Vital Capacity (FVC)

  Week -3 through extension follow up Month 3 or end of study

• Total Lung Capacity (TLC)

  Baseline through extension follow up Month 3

• Change From Baseline in Glycosylated Hemoglobin (HbA1c)

  Baseline through extension follow up Month 3

• Change From Baseline in Fasting Plasma Glucose (FPG)

  Baseline through extension follow up Month 3

• Change From Baseline in Body Weight

  Baseline through extension follow up Month 3

Study Arms (2)

Inhaled Insulin

EXPERIMENTAL

Inhalable short-acting insulin

Drug: Inhaled Insulin

Subcutaneous insulin

ACTIVE COMPARATOR

Drug: Subcutaneous insulin

Interventions

Inhaled Insulin DRUG

Inhaled insulin with dose adjusted according to premeal blood glucose

Also known as: Exubera

Inhaled Insulin

Subcutaneous insulin DRUG

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Subcutaneous insulin

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus

You may not qualify if:

• COPD
• Asthma
• Smoking Pregnancy

Sponsors & Collaborators

• Pfizer: lead

Study Sites (92)

Pfizer Investigational Site

Phoenix, Arizona, 85016, United States

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Tucson, Arizona, 85715, United States

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Fresno, California, 93720, United States

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Greenbrae, California, 94904, United States

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Los Angeles, California, 90073, United States

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Sacramento, California, 95816, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Luis Obispo, California, 93401, United States

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Tustin, California, 92780, United States

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Walnut Creek, California, 94598, United States

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Denver, Colorado, 80209, United States

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Hamden, Connecticut, 06518, United States

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Madison, Connecticut, 06443, United States

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New Britain, Connecticut, 06050, 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, 33761, United States

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Fort Myers, Florida, 33901, United States

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Hollywood, Florida, 33021, United States

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Miami, Florida, 33156, United States

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Ocala, Florida, 34471, United States

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Palm Harbor, Florida, 34684, United States

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Tallahassee, Florida, 32308, United States

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West Palm Beach, Florida, 33401, United States

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Honolulu, Hawaii, 96813, United States

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Honolulu, Hawaii, 96814, United States

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Chicago, Illinois, 60602, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60610, United States

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Springfield, Illinois, 62704, United States

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Wilmette, Illinois, 60091, United States

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New Orleans, Louisiana, 70112, United States

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Bethesda, Maryland, 20817, United States

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Boston, Massachusetts, 02215, United States

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Ann Arbor, Michigan, 48106, United States

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Bloomfield Hills, Michigan, 48302, United States

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Plymouth, Michigan, 48170, United States

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Royal Oak, Michigan, 48073, United States

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Southfield, Michigan, 48034, United States

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Chesterfield, Missouri, 63017, 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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Lincoln, Nebraska, 68521, United States

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Henderson, Nevada, 89014, United States

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Albuquerque, New Mexico, 87108, United States

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Albuquerque, New Mexico, 87109, United States

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Mineola, New York, 11501, United States

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New Hyde Park, New York, 11042, United States

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Rochester, New York, 14609, United States

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Durham, North Carolina, 27713, United States

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Winston-Salem, North Carolina, 27103, United States

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Mansfield, Ohio, 44903, United States

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Tulsa, Oklahoma, 74104, United States

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Warwick, Rhode Island, 02886, United States

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Beaumont, Texas, 77701, United States

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Beaumont, Texas, 77706, United States

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Corpus Christi, Texas, 78411, United States

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Corpus Christi, Texas, 78412, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77079, United States

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Irving, Texas, 75061, United States

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San Antonio, Texas, 78229, United States

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Burlington, Vermont, 05401, United States

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Richmond, Virginia, 23225, United States

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Renton, Washington, 98055, United States

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Milwaukee, Wisconsin, 53209, United States

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

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São Paulo, São Paulo, 01244-030, Brazil

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Calgary, Alberta, T2T 5C7, Canada

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Calgary, Alberta, T3B 0M3, Canada

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Red Deer, Alberta, T4N 6V7, Canada

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Victoria, British Columbia, V8R 1J8, Canada

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Winnepeg, Manitoba, R3A 1R9, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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London, Ontario, N6A 4V2, Canada

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Ottawa, Ontario, K1H 1A2, Canada

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Toronto, Ontario, M4N-3M5, Canada

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Toronto, Ontario, M5G 1X5, Canada

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Laval, Quebec, H7T 2P5, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Aguas Buenas, 00703, Puerto Rico

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Añasco, 00610, Puerto Rico

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Cabo Rojo, 00623, Puerto Rico

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San Juan, 00909, Puerto Rico

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San Juan, 00921, Puerto Rico

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Related Publications (2)

• 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.

  PMID: 19905885 DERIVED

• 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.

  PMID: 18535196 DERIVED

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Exubera

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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 25, 2005
• First Posted: August 29, 2005
• Study Start: June 1, 2002
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 18, 2010
• Results First Posted: January 18, 2010

Record last verified: 2009-12

Locations

US (69); CA (16); PR (5); BR (2)