Status:
COMPLETED
Evaluate Saxagliptin in Adult Indian 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 Indian patients with inadequate gl...
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 :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00918879
Start Date
May 1 2009
End Date
July 1 2010
Last Update
September 26 2011
Active Locations (9)
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1
Research Site
Gujarat, Ahmedabad, India
2
Research Site
Karnataka, Bangalore, India
3
Research Site
Tamil Nadu, Chennai, India
4
Research Site
Tamil Nadu, Coimbatore, India