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A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

Last updated on November 12, 2019

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Study Location
Gain Medical Center
Coquitlam, British Columbia, V3K 3P4 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus Type 2
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diabetes mellitus type 2

- Failing two or more oral anti-diabetic agents

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

- Asthma, COPD

- Smoking

NCT00282971
Pfizer
Terminated
A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

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Descriptive Information
Brief Title  ICMJE A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents
Brief SummaryTo assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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 Insulin (Exubera)
    Addition of inhaled insulin to pre-existing oral diabetes therapy.
  • Other: Standard of Care
    Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Study Arms  ICMJE
  • Experimental: Inhaled Insulin
    Inhaled insulin plus oral therapy
    Intervention: Drug: Inhaled Insulin (Exubera)
  • Standard of Care
    Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
    Intervention: Other: Standard of Care
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: November 26, 2008)
354
Original Enrollment  ICMJE
 (submitted: January 26, 2006)
610
Actual Study Completion Date  ICMJE February 19, 2008
Actual Primary Completion DateFebruary 19, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetes mellitus type 2
  • Failing two or more oral anti-diabetic agents

Exclusion Criteria:

  • Asthma, COPD
  • Smoking
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 35 Years to 80 Years   (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 Canada,   France,   Greece,   Portugal,   Spain,   Sweden,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282971
Other Study ID Numbers  ICMJE A2171063
EXACTA ( Other Identifier: Alias Study Number )
2005-003504-11 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2019

ICMJE     Data element required by the

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

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