Status:
COMPLETED
Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glyca...
Eligibility Criteria
Inclusion
- Diagnosed with Type 2 diabetes
- Treatment with metformin at a stable dose \>1500 mg/day
- HbA1c ≥ 7.0% and ≤10.0%
Exclusion
- Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
- Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT00661362
Start Date
June 1 2008
End Date
September 1 2009
Last Update
March 8 2012
Active Locations (30)
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1
Research Site
Hefei, Anhui, China
2
Research Site
Beijing, China, China
3
Research Site
Chongqing, China, China
4
Research Site
Guangzhou, Guangdong, China