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

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ClinicalTrials.gov Identifier: NCT00282971
Recruitment Status : Terminated (Terminated as marketing of this product will be discontinued)
First Posted : January 27, 2006
Results First Posted : August 26, 2009
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

January 26, 2006
January 27, 2006
February 11, 2009
August 26, 2009
March 2, 2018
March 6, 2006
February 19, 2008   (Final data collection date for primary outcome measure)
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: 4, 12 and 24 weeks ]
[(week 24 value - baseline value)/baseline value]*100%
Glycosylated hemoglobin
Complete list of historical versions of study NCT00282971 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Achieving Glycemic Control by Visit [ Time Frame: 4, 12 and 24 weeks ]
    2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%
  • Change From Baseline in FEV1 at Week 24 LOCF [ Time Frame: 24 weeks ]
Percent of patients achieving good control of fasting glucose and lipids; Rate of hypoglycemia; Changes in body weight; Patient satisfaction; Safety based on adverse events reported and laboratory tests
Not Provided
Not Provided
 
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(Registered)) 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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • 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
  • 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
610
February 19, 2008
February 19, 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 ( Other Identifier: Alias Study Number )
2005-003504-11 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2018

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