Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin in Type 2 Diabetes Mellitus Patients ≥ 70 Years (Drug-naive or Inadequately Controlled on Oral Agents)
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo [ Time Frame: 24 weeks ]
Secondary Outcome Measures :
To evaluate the safety and tolerability of vildagliptin in elderly patients with T2DM who are drug-naive or inadequately controlled with oral antidiabetic drugs (OADs) including physical exam, vital sign, hematology, chemistry and electrocardiogram. [ Time Frame: 24 weeks ]
To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo [ Time Frame: 24 weeks ]
To assess the responder rates of patients treated with vildagliptin as compared to placebo [ Time Frame: 24 weeks ]
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Ages Eligible for Study:
70 Years and older (Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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