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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282971

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00282971     History of Changes
Other Study ID Numbers: A2171063, EXACTA
Study First Received: January 26, 2006
Results First Received: February 11, 2009
Last Updated: September 11, 2009
Health Authority: United States: Food and Drug Administration

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013