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

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NCT00437489

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Study Location
Pfizer Investigational Site
Hong Kong, , , Hong Kong
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1-800-718-1021
[email protected]
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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.
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- Severe Asthma, severe COPD


- Smoking

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Control
    Intervention: Drug: Inhaled Human Insulin (Exubera)
  • Experimental: Experimental
    Intervention: Drug: Inhaled Human Insulin (Exubera)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 20, 2008)		49
Original Enrollment  ICMJE
 (submitted: February 20, 2007)		424
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe Asthma, severe COPD
  • Smoking
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong,   Pakistan,   Philippines,   Singapore
Removed Location Countries Malaysia
 
Administrative Information
NCT Number  ICMJE NCT00437489
Other Study ID Numbers  ICMJE A2171086
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP