Status:
COMPLETED
Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes
Lead Sponsor:
Novartis
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ 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 monotherapy.
Eligibility Criteria
Inclusion
- Patients at least 18 years of age at Visit 1
- Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
- HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
- Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1
Exclusion
- Pregnant or lactating female
- FPG ≥ 270 mg/dL (≥15 mmol/L)
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT00821977
Start Date
November 1 2008
End Date
October 1 2010
Last Update
December 17 2020
Active Locations (176)
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1
Advanced Clinical Research
Pell City, Alabama, United States, 35128
2
Horizon Clinical Research Associates, PLLC
Gilbert, Arizona, United States, 85206
3
Vista Medical Research, Inc
Mesa, Arizona, United States, 85206
4
Clinical Research Advantage
Mesa, Arizona, United States, 85213