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Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety (VOLUME)

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ClinicalTrials.gov Identifier: NCT00359801
Recruitment Status : Completed
First Posted : August 2, 2006
Results First Posted : January 27, 2010
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care Phase 4

Detailed Description:
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time, Pfizer committed to continued marketing until it returned the licensing rights for the technology to Nektar. Following the announcement, enrollment was halted. Subjects already enrolled and receiving treatment at the time of the halt in enrollment could continue in the study in accordance with the protocol. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, an amendment was filed on April 16, 2008 specifying that all subjects randomized to Exubera had to be transitioned to usual diabetes care, and all study subjects followed for serious adverse events for 6 months. In accordance with this amendment, study A2171069 was terminated on April 29, 2009. Neither safety nor efficacy reasons were the cause of the study termination.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1976 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International, Multicenter, Large Simple Trial To Evaluate The Long-Term Pulmonary And Cardiovascular Safety Of Exubera In Patients With Diabetes Mellitus
Study Start Date : July 2006
Primary Completion Date : December 2008
Study Completion Date : April 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: Exubera Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions.
Active Comparator: Usual Diabetes Care Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
Other Name: Non-Exubera


Outcome Measures

Primary Outcome Measures :
  1. Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline [ Time Frame: Baseline, Month 6, Year 1, Year 2, Index Visit ]
  2. Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects [ Time Frame: Baseline, Month 6, Year 1, Year 2, Index Visit ]
  3. Time to Persistent Decline in FEV1 Exceeding 20% From Baseline [ Time Frame: Baseline to 5 years ]

Secondary Outcome Measures :
  1. Change From Baseline in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline, Week 26, Week 52, Week 104, Index Visit ]
  2. Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis [ Time Frame: Baseline through End of Study ]
  3. Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis [ Time Frame: Baseline to 5 years ]
  4. All-cause Mortality: Number of Deaths [ Time Frame: Baseline through End of Study ]
  5. Time to Event: All-cause Mortality [ Time Frame: Baseline to 5 years ]
  6. Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke [ Time Frame: Baseline through End of Study ]
  7. Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke [ Time Frame: Baseline to 5 years ]
  8. Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm [ Time Frame: Baseline through End of Study ]
  9. Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm [ Time Frame: Baseline to 5 years ]
  10. Change in Glycosylated Hemoglobin (HbA1c) From Baseline [ Time Frame: Baseline, Month 6, Year 1, Year 2, Index Visit ]
  11. Change in Glycosylated Hemoglobin (HbA1c) From Baseline [ Time Frame: Baseline to 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for receiving Exubera treatment based on the approved local label

Exclusion Criteria:

  • Pregnant or lactating
  • Have a progressive fatal disease or a life expectancy that prohibits them from participating in a five-year research study
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): NCT00359801


  Show 197 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: NCT00359801     History of Changes
Other Study ID Numbers: A2171069
First Posted: August 2, 2006    Key Record Dates
Results First Posted: January 27, 2010
Last Update Posted: February 2, 2010
Last Verified: September 2009

Keywords provided by Pfizer:
Large Simple Trial

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