Status:
COMPLETED
Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-77 years
Phase:
PHASE3
Brief 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 ...
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 (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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
1035 Patients enrolled
Trial Details
Trial ID
NCT00121641
Start Date
July 1 2005
End Date
February 1 2010
Last Update
April 3 2015
Active Locations (134)
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Local Institution
Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Calera, Alabama, United States
4
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Jonesboro, Arizona, United States