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

September 6, 2005
October 28, 2008
January 2003
Not Provided
Glycosylated hemoglobin
Same as current
Complete list of historical versions of study NCT00150410 on ClinicalTrials.gov Archive Site
  • 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.
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
Not Provided
Not Provided
 
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
  • 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Drug: Inhaled insulin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
626
June 2007
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Canada,   Mexico
 
NCT00150410
A2171017
Not Provided
Not Provided
Pfizer
Sanofi
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

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