Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)
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Multi-center, Open-label, 24-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin 50/500 or 50/1000 mg Twice Daily in Patients With T2DM Inadequately Controlled With Metformin
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
HbA1c reduction [ Time Frame: 24 weeks after treatment ]
Secondary Outcome Measures :
Proportion of patients who achieve target of HbA1c<6.5% at the end of study [ Time Frame: 24 weeks after treatment ]
To evaluate the effect of combination therapy of vildagliptin (50 mg) plus metformin (500 or 1000 mg) twice daily on FPG and BMI, safety and tolerability profiles [ Time Frame: 24 weeks after treatment ]
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Ages Eligible for Study:
18 Years to 78 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
The patient is required to have HbA1c 6.5-11.0%
BMI in the range of 22-48 kg/m2
Severe or uncontrolled Type 2 diabetes mellitus (HbA1c> 11.0%)
Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months