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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359801

A2171069

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,976 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,976 participants in 2 patient groups

Exubera

Experimental group

Treatment:

Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care

Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care

Usual Diabetes Care

Active Comparator group

Treatment:

Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care

Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care