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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 August 9, 2018

FOR MORE INFORMATION
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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A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus
A Six Month, Open-Label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-Diabetic Agents.
To 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
The study was terminated on Nov. 9, 2007. This study pursued scientific questions that were complementary to the wealth of data already available for Exubera. Pfizer decided to cancel new trials because of the decision to withdraw Exubera due to lack of market performance and not for safety reasons.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Other: Standard of Care
    Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
  • Drug: Inhaled Insulin (Exubera)
    Addition of inhaled insulin to pre-existing oral diabetes therapy.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
354
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Asthma, COPD
  • Smoking
Sexes Eligible for Study: All
35 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Greece,   Portugal,   Spain,   Sweden,   Turkey
 
 
NCT00282971
A2171063
EXACTA
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 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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1-800-718-1021

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[email protected]



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