Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Vildagliptin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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