Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose
Phase 3
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT00150410
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 626
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Glycosylated hemoglobin
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇲🇽Mexico Df, Mexico