A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Inhaled Human Insulin (Exubera)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437489

A2171086

Details and patient eligibility

About

The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes mellitus Type 2
• Currently treated with at least 2 oral anti-diabetic agents

Exclusion criteria

• Severe Asthma, severe COPD
• Smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Control

Active Comparator group

Treatment:

Drug: Inhaled Human Insulin (Exubera)

Drug: Inhaled Human Insulin (Exubera)

Experimental

Experimental group

Treatment:

Drug: Inhaled Human Insulin (Exubera)

Drug: Inhaled Human Insulin (Exubera)