Status:
COMPLETED
A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes
Detailed Description
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to ...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus
- Drug naive
- Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
- Fasting C-peptide ≥1.0 ng/mL
- Body mass index ≤40 kg/m²
Exclusion
- Recent cardiac or cerebrovascular event
- Elevated serum creatinine
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00374907
Start Date
September 1 2006
End Date
December 1 2009
Last Update
May 7 2015
Active Locations (3)
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1
Va San Diego Healthcare System
San Diego, California, United States, 92161
2
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
3
Diabetes & Glandular Disease Research Assoc,, Inc.
San Antonio, Texas, United States, 78229