Status:
COMPLETED
Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
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 with inadequate glycaemic...
Eligibility Criteria
Inclusion
- Diagnosed with Type 2 diabetes
- Patients should be drug naïve ie, not received medical treatment for diabetes,
- HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)
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 :
October 1 2009
Estimated Enrollment :
568 Patients enrolled
Trial Details
Trial ID
NCT00698932
Start Date
June 1 2008
End Date
October 1 2009
Last Update
September 21 2011
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
Fuzhou, Fujian, China