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

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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 : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
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(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents
Actual Study Start Date : March 6, 2006
Actual Primary Completion Date : February 19, 2008
Actual Study Completion Date : February 19, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. 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%

  2. Change From Baseline in FEV1 at Week 24 LOCF [ Time Frame: 24 weeks ]


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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

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


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Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00282971     History of Changes
Other Study ID Numbers: A2171063
EXACTA ( Other Identifier: Alias Study Number )
2005-003504-11 ( EudraCT Number )
First Posted: January 27, 2006    Key Record Dates
Results First Posted: August 26, 2009
Last Update Posted: March 2, 2018
Last Verified: February 2018

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