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

This study has been completed.

Sponsor:

Collaborator:

Sanofi

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00150410

First received: September 6, 2005

Last updated: October 28, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

October 28, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Glycosylated hemoglobin

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00150410 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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 clinic

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Drug: Inhaled insulin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

626

Completion Date

June 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Brazil, Canada, Mexico

Administrative Information

NCT Number ^ICMJE

NCT00150410

Other Study ID Numbers ^ICMJE

A2171017

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Sanofi

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top