Conditions: Diabetes Mellitus
Keywords: Large Simple Trial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1976
Healthy volunteers: no

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

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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care intervention 2: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Intervention descriptions: intervention 1: 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. intervention 2: 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).

Protocol document: