A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control

A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00134147

Enrollment

1100

Registered

2005-08-24

Start date

2005-04-30

Completion date

2007-05-31

Last updated

2008-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief summary

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

Interventions

DRUGInhaled Insulin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Diabetes mellitus Type 2 * Failing two or more oral anti-diabetic agents

Exclusion criteria

* Asthma, COPD * Smoking

Design outcomes

Primary

Measure	Time frame
Glycosylated hemoglobin	—

Secondary

Measure	Time frame
Percent of patients achieving good control of fasting glucose and lipids	—
Rate of hypoglycemia	—
Changes in body weight	—
Patient satisfaction	—
Safety based on adverse events reported and laboratory tests	—

Countries

Canada, France, Germany, Italy, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026