Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose
|ClinicalTrials.gov Identifier: NCT00150410|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : October 31, 2008
- 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 or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Drug: Inhaled insulin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||626 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2003|
|Actual Study Completion Date :||June 2007|
- Glycosylated hemoglobin
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150410
Show 120 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|