Status:
COMPLETED
A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
Lead Sponsor:
Novartis
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fast...
Eligibility Criteria
Inclusion
- Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
- Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
- Body mass index 22-40 kg/meter squared
- HbA1c \> 11% and/or FPG \>270 mg/dL
Exclusion
- Pregnant or lactating female
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agent
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
March 6 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2008
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00468039
Start Date
March 6 2007
End Date
June 6 2008
Last Update
December 19 2020
Active Locations (1)
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1
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States, 78229