Official Title: “A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone”

The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Saxagliptin

Primary Measures

• Change in baseline A1C value after 24 weeks of treatment.

Secondary Measures

• Change from baseline in fasting plasma glucose
• Proportion of subjects achieving A1C < 7%
• Change from baseline in area under the curve for postprandial glucose response to an oral glucose tolerance test
• Proportion of subjects who rescue or discontinue for lack of efficacy

Inclusion Criteria:

• Type 2 Diabetes.
• Treated with a sulfonylurea for at least 2 months.
• Inadequate blood sugar control.
• Are not on any other medications to lower blood sugar.
• No major heart, liver or kidney problems.
• Age 18-77
• Male or female
• Women not pregnant or breast feeding.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 77 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bristol-Myers Squibb

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00313313

Study ID Number: CV181-040

ClinicalTrials.gov Identifier: NCT00313313

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm