Status:
COMPLETED
Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
70+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).
Eligibility Criteria
Inclusion
- age: ≥ 70 years inclusive at Visit 1.
- patients with a confirmed diagnosis of T2DM
- HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled
- body mass index (BMI) in the range of 19-45kg/m2
Exclusion
- FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
- previous or current participation in any vildagliptin clinical study.
- history of hypersensitivity to DPP-4 inhibitors.
- concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
- donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT01257451
Start Date
December 1 2010
End Date
March 1 2012
Last Update
December 18 2012
Active Locations (46)
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1
Novartis Investigative Site
Wichelen, Belgium, Belgium, 9260
2
Novartis Investigative Site
Buizingen, Belgium, 1501
3
Novartis Investigative Site
De Pinte, Belgium, 9840
4
Novartis Investigative Site
Genk, Belgium, 3600