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Therapeutic Areas: Endocrinology
Disease Category: Diabetes Mellitus, Type 2

Trial Information

A 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination With Metformin XR 1500 mg Versus Uptitrated Metformin XR to 2000 mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg

The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR versus uptitrated Metformin XR

Inclusion Criteria:

• Type 2 diabetes
• 18-78 years of age
• Taking stable dose of metformin IR or XR ≥1000 mg and ≤1500 mg as monotherapy for at lease 8 weeks prior to screening
• A1C: 7.5-11% (at screening)
• C-peptide: ≥1.0 ng/mL
• BMI: ≤ 40kg/m²

Exclusion Criteria:

• Women of childbearing potential unable or unwilling to use acceptable birth control
• Women who are pregnant or breastfeeding
• Significant cardiovascular history
• Active liver disease
• Renal impairment

Tracy Critchfield, MSM, Marketing/Recruitment Specialist
Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr., Suite 700
San Antonio, TX 78229
Phone: 210.949.0122
Fax: 210.949.0181

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