Status:
COMPLETED
Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with ty...
Eligibility Criteria
Inclusion
- Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
- Body mass index in the range 22-40
- Blood glucose criteria must be met
Exclusion
- Pregnancy or lactation
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT00351884
Start Date
May 1 2006
Last Update
November 18 2016
Active Locations (2)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
2
Novartis Investigative Site
Investigative Centers, Germany