Status:
COMPLETED
Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone
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 added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not su...
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 requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
- HbA1c \>= 7.0% and \<= 10.0 %
- Body mass index \<= 40 kg/m2
- Fasting C-peptide \>= 1 ng/dL
Exclusion
- Symptomatic poorly controlled diabetes
- Recent cardiac or cerebrovascular event
- Serum creatinine \>= 1.5 mg/dL for males and \>= 1.4 mg/dL for females
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
1462 Patients enrolled
Trial Details
Trial ID
NCT00121667
Start Date
August 1 2005
End Date
February 1 2010
Last Update
April 29 2015
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Calera, Alabama, United States
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Haleyville, Alabama, United States