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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 26, 2006
First Posted Date  ICMJE January 27, 2006
Results First Submitted Date  ICMJE February 11, 2009
Results First Posted Date  ICMJE August 26, 2009
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE March 6, 2006
Actual Primary Completion Date February 19, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
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%
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2006)
Glycosylated hemoglobin
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2006)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary 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
Detailed Description Not 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 Date February 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 Committee No
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 Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2019

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