Status:
COMPLETED
Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-77 years
Phase:
PHASE3
Brief Summary
This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00683657
Start Date
July 1 2008
End Date
February 1 2009
Last Update
June 1 2015
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Dedicated Phase I, Inc.
Phoenix, Arizona, United States, 85013
2
Amcr Institute, Inc
Escondido, California, United States, 92026
3
Irvine Center For Clinical Research, Inc.
Irvine, California, United States, 92618
4
Pacific Sleep Medicine Services (Avastra Clinical Trials)
Redlands, California, United States, 92373