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.)
Information provided by:
ClinicalTrials.gov Identifier:
First received: January 26, 2006
Last updated: September 11, 2009
Last verified: July 2009
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:

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.

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Asthma, COPD
  • Smoking
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282971

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Sponsors and Collaborators
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 
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016