Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Metformin; Saxagliptin

Criteria

Inclusion Criteria:

• Type 2 diabetes mellitus

• Drug naive

• Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)

• Fasting C-peptide >= 1 ng/mL

• Body mass index <= 40 kg/m2

Exclusion Criteria:

• Symptomatic poorly controlled diabetes

• Recent cardiac or cerebrovascular event

• Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing Potential