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A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.

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NCT00437489

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hong Kong, , Hong Kong
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diabetes mellitus Type 2

- Currently treated with at least 2 oral anti-diabetic agents

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

- Severe Asthma, severe COPD

- Smoking

NCT00437489
Pfizer
Terminated
A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.

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A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.
A 16 Week Open-Label Outpatient, Randomized, Parallel Study Assessing The Impact Of Two Different Initial Dose Prescriptions For Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents.
The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Inhaled Human Insulin (Exubera)
    Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID
  • Drug: Inhaled Human Insulin (Exubera)
    Initial dose of 1mg TID of inhaled human insulin
  • Active Comparator: Control
    Intervention: Drug: Inhaled Human Insulin (Exubera)
  • Experimental: Experimental
    Intervention: Drug: Inhaled Human Insulin (Exubera)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
49
December 2007
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetes mellitus Type 2
  • Currently treated with at least 2 oral anti-diabetic agents

Exclusion Criteria:

  • Severe Asthma, severe COPD
  • Smoking
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   Pakistan,   Philippines,   Singapore
Malaysia
 
NCT00437489
A2171086
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2009

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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