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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00282971
First received: January 26, 2006
Last updated: September 11, 2009
Last verified: July 2009
History of Changes

January 26, 2006
September 11, 2009
March 2006
February 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Change From Baseline in FEV1 at Week 24 LOCF [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
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) 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Greece,   Portugal,   Spain,   Sweden,   Turkey
 
NCT00282971
A2171063, EXACTA
No
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