A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

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

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Intervention(s) in this Clinical Trial

• Drug: Saxagliptin
  • Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT])
• Drug: Saxagliptin
  • Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
• Drug: Glyburide
  • Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
• Drug: Placebo
  • Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)
• Drug: Glyburide
  • Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)
• Drug: Metformin
  • Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)
  • Metformin 500-2500 mg (as needed)
• Experimental: Saxagliptin 5 mg + Glyburide 7.5 mg (B)
  • Metformin 500-2500 mg (as needed)
• Placebo Comparator: Placebo + Glyburide 7.5 mg (C)
  • Metformin 500-2500 mg (as needed)

Primary Measures

• Change From Baseline in Hemoglobin A1c (A1C) at Week 24
  • Time Frame: Baseline, Week 24
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
  • Time Frame: Baseline, Week 24
    Safety Issue?: No
• Percentage of Participants Achieving A1C < 7% at Week 24
  • Time Frame: Week 24
    Safety Issue?: No
• Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
  • Time Frame: Baseline, Week 24
    Safety Issue?: No

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.
• 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 Investigator: Bristol-Myers Squibb Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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