Status:
COMPLETED
Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-78 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin
Eligibility Criteria
Inclusion
- Patients 18-78 years old inclusive at Visit 1
- T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1
- Patient agreement to maintain same dose of metformin throughout study
- HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
- Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1
Exclusion
- Pregnant or nursing (lactating) women
- FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1988 Patients enrolled
Trial Details
Trial ID
NCT00860288
Start Date
February 1 2009
End Date
March 1 2011
Last Update
December 29 2020
Active Locations (187)
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1
Instituto de Investigaciones Biomedicas
Buenos Aires, Santa Fe Province, Argentina, 3000FNF
2
Grupo Colaborative Rosario
Rosario, Santa Fe Province, Argentina, S2002OJP
3
Grupo Medico Alem
Buenos Aires, Argentina, B1642DCD
4
DIM Clinical Privada
Buenos Aires, Argentina, B1704ETD