Status:
COMPLETED
Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately c...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- 18-78 years of age
- Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
- Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
- Fasting C-peptide: ≥1.0 ng/mL
- FPG≥126 mg/dl obtained at the Day -7 visit
- Body mass index (BMI): ≤ 40kg/m²
- A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization
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 :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00918138
Start Date
August 1 2009
End Date
May 1 2010
Last Update
May 21 2015
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Dedicated Phase I, Inc.
Phoenix, Arizona, United States, 85013
2
Pacific Sleep Medicine Services (Avastra Clinical Trials)
Redlands, California, United States, 92373
3
Orange County Research Center
Tustin, California, United States, 92780
4
Clinical Research Of South Florida
Coral Gables, Florida, United States, 33134