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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Glendale, Arizona, 85306 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma, Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-77 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin

- Mild intermittent or mild to moderate persistent asthma

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking

NCT00139659
Pfizer
Completed
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma

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A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma
Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Asthma: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Asthma
  • Diabetes Mellitus
  • Drug: Inhaled Insulin
    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.
  • Drug: Subcutaneous Insulin
    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.
  • Experimental: Inhaled Insulin
    Intervention: Drug: Inhaled Insulin
  • Active Comparator: Subcutaneous Insulin
    Intervention: Drug: Subcutaneous Insulin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
October 2008
October 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
  • Mild intermittent or mild to moderate persistent asthma

Exclusion Criteria:

  • Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking
Sexes Eligible for Study: All
18 Years to 77 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   Costa Rica,   Germany,   United States
 
 
NCT00139659
A2171028
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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