Status:
COMPLETED
Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose in lowering overal...
Eligibility Criteria
Inclusion
- Not currently on drug therapy for type 2 diabetes
- Body mass index (BMI) in the range 20-40
- Blood glucose criteria must be met
Exclusion
- Pregnancy or lactation
- Type 1 diabetes
- Evidence of significant diabetic complications
- Evidence of serious cardiovascular conditions
- Laboratory value abnormalities as defined by the protocol
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT00110240
Start Date
April 1 2005
End Date
October 1 2006
Last Update
May 7 2012
Active Locations (1)
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1
Novartis Pharmaceuticals
Basel, Switzerland