Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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
Primary Completion Date
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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