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

This study has been completed.

First Received: September 6, 2005 Last Updated: October 28, 2008 History of Changes

Sponsor:	Pfizer
Collaborator:	Sanofi-Aventis
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00150410

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Inhaled insulin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate Metformin

Further study details as provided by Pfizer:

Primary Outcome Measures:

Secondary Outcome Measures:

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.

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150410

Sponsors and Collaborators

Pfizer

Sanofi-Aventis

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A2171017
Study First Received:	September 6, 2005
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00150410 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on February 08, 2010