Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: Exubera® (inhaled insulin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00143247

A2171036

Details and patient eligibility

About

This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).

Full description

The study was terminated on Oct. 18, 2007. This study is not a post approval commitment study. Pfizer decided to cancel new trials because of the decision to withdraw Exubera® (inhaled insulin) due to lack of market performance and not for safety reasons.

Enrollment: 173 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols

Exclusion criteria

• Smoking
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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173 participants in 1 patient group

Exubera® (inhaled insulin)

Experimental group

Description:

Open label, no comparator

Treatment:

Drug: Exubera® (inhaled insulin)