A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

Pfizer

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Inhaled Human Insulin (Exubera®); Drug: Insulin Glargine (Lantus®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00391027

A2171084

Details and patient eligibility

About

To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.

Enrollment: 261 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes Mellitus, Type 2 on oral agents
• Age > 30 years

Exclusion criteria

• Severe Asthma, severe Chronic Obstructive Pulmonary Disease
• Smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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261 participants in 2 patient groups

Insulin Glargine (Lantus®)

Active Comparator group

Treatment:

Drug: Insulin Glargine (Lantus®)

Inhaled Human Insulin (Exubera®)

Active Comparator group

Treatment:

Drug: Inhaled Human Insulin (Exubera®)