A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease; Diabetes Mellitus

Treatments: Drug: Subcutaneous Insulin; Drug: Inhaled Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00138671

A2171030

Details and patient eligibility

About

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.

Full description

Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for study A2171030 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 A2171030 was terminated on June 17, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Enrollment: 105 patients

Sex: All

Ages: 30 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
• Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC < 70%) and FEV1 < 80% predicted and/or a history of chronic productive cough.

Exclusion criteria

• Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Subcutaneous Insulin

Active Comparator group

Treatment:

Drug: Subcutaneous Insulin

Inhaled Insulin

Experimental group

Treatment:

Drug: Inhaled Insulin