Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Metformin; Saxagliptin

Criteria

Inclusion Criteria:

• ≥18- and ≤77-years-old

• Type 2 diabetes

• Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy

• Glycosylated hemoglobin (A1C) ≥7% and ≤10%

• Body mass index (BMI) ≤40 kg/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