A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Insulin lispro (Humalog); Drug: Inhaled Human Insulin (Exubera®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00356421

A2171035

Details and patient eligibility

About

To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus

Full description

Pfizer announced in October 2007 that it would stop marketing Exubera®. At that time recruitment for study, A2171035 was placed on hold. 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, study A2171035 was terminated on May 12, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes mellitus Type 1

Exclusion criteria

• Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
• Smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Control

Active Comparator group

Treatment:

Drug: Insulin lispro (Humalog)

Experimental

Experimental group

Treatment:

Drug: Inhaled Human Insulin (Exubera®)