Status:
COMPLETED
Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes
Eligibility Criteria
Inclusion
- Age from 65 years to the upper age limit recommended by local prescribing information for metformin
- Drug naive patients with type 2 diabetes.
- Body mass index (BMI) in the range of 22-40 kg/m2.
- HbA1c in the range of 7 to 9% inclusive
- FPG \<270 mg/dL (15 mmol/L)
Exclusion
- A history of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agents
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT00383578
Start Date
September 1 2006
Last Update
December 17 2020
Active Locations (2)
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1
Investigative Centers
Nuremberg, Germany
2
Novartis Pharmaceuticals
Basel, Switzerland