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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:
ClinicalTrials.gov Identifier:
NCT00282971
First Posted: January 27, 2006
Last Update Posted: September 15, 2009
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.
Information provided by:
Pfizer
  Purpose
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

Condition Intervention Phase
Diabetes Mellitus Type 2 Other: Standard of Care Drug: Inhaled Insulin (Exubera) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: 4, 12 and 24 weeks ]

Secondary Outcome Measures:
  • Percentage of Participants Achieving Glycemic Control by Visit [ Time Frame: 4, 12 and 24 weeks ]
  • Change From Baseline in FEV1 at Week 24 LOCF [ Time Frame: 24 weeks ]

Enrollment: 354
Study Start Date: March 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Insulin
Inhaled insulin plus oral therapy
Drug: Inhaled Insulin (Exubera)
Addition of inhaled insulin to pre-existing oral diabetes therapy.
Standard of Care
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Other: Standard of Care
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Asthma, COPD
  • Smoking
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282971


  Show 63 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00282971     History of Changes
Other Study ID Numbers: A2171063
EXACTA
First Submitted: January 26, 2006
First Posted: January 27, 2006
Results First Submitted: February 11, 2009
Results First Posted: August 26, 2009
Last Update Posted: September 15, 2009
Last Verified: July 2009

Keywords provided by Pfizer:
Type 2 diabetes melllitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs