A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus Type 2

Treatments: Other: Standard of Care; Drug: Inhaled Insulin (Exubera)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00282971

A2171063

2005-003504-11 (EudraCT Number)

EXACTA (Other Identifier)

Details and patient eligibility

About

To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Enrollment: 354 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes mellitus type 2
• Failing two or more oral anti-diabetic agents

Exclusion criteria

• Asthma, COPD
• Smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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354 participants in 2 patient groups

Inhaled Insulin

Experimental group

Description:

Inhaled insulin plus oral therapy

Treatment:

Drug: Inhaled Insulin (Exubera)

Standard of Care

Other group

Description:

Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Treatment:

Other: Standard of Care