Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose

A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing Exubera® (Insulin Dry Powder Pulmonary Inhaler) vs. Avandia® (Rosiglitazone Maleate) as Add-On Therapy vs. Exubera® Substitution of Sulfonylurea in Patients With Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150410

Enrollment

626

Registered

2005-09-08

Start date

2003-01-31

Completion date

2007-06-30

Last updated

2008-10-31

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

Conditions

Diabetes Mellitus

Brief summary

* Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug. * Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.

Interventions

DRUGInhaled insulin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Currently treated and on a stable doses of drugs for the preceding two (2) months

Exclusion criteria

* Type 1 Diabetes * Smoking

Design outcomes

Primary

Measure	Time frame
Glycosylated hemoglobin	—

Secondary

Measure	Time frame
Change from baseline in fasting plasma glucose. Other secondary efficacy	—
endpoints include, body weight, patient reported outcomes, incidence and severity	—
of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to	—
insufficient clinical response.	—

Countries

Australia, Brazil, Canada, Mexico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026