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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00359801
First received: July 31, 2006
Last updated: January 29, 2010
Last verified: September 2009
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Time to Persistent Decline in FEV1 Exceeding 20% From Baseline [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline, Week 26, Week 52, Week 104, Index Visit ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • All-cause Mortality: Number of Deaths [ Time Frame: Baseline through End of Study ] [ Designated as safety issue: Yes ]
  • Time to Event: All-cause Mortality [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: Yes ]
  • Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke [ Time Frame: Baseline through End of Study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm [ Time Frame: Baseline through End of Study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change in Glycosylated Hemoglobin (HbA1c) From Baseline [ Time Frame: Baseline, Month 6, Year 1, Year 2, Index Visit ] [ Designated as safety issue: No ]
  • Change in Glycosylated Hemoglobin (HbA1c) From Baseline [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]

Enrollment: 1976
Study Start Date: July 2006
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359801

  Show 197 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: NCT00359801     History of Changes
Other Study ID Numbers: A2171069
Study First Received: July 31, 2006
Results First Received: December 22, 2009
Last Updated: January 29, 2010
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
Large Simple Trial

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

ClinicalTrials.gov processed this record on May 22, 2013