This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,988
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment
Time frame: 24 weeks
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of sitagliptin added to metformin after 24 weeks of treatment.
Time frame: 24 weeks
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment.
Time frame: 24 weeks
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of sitagliptin added to metformin.
Time frame: 24 weeks
To evaluate the safety and tolerability of vildagliptin compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.
Time frame: 24 weeks
To evaluate the long-term safety and tolerability of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.
Time frame: 76 weeks
To evaluate the body weight change from baseline with vildagliptin compared to placebo and sitagliptin after 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Instituto de Investigaciones Biomedicas
Buenos Aires, Santa Fe Province, Argentina
Grupo Colaborative Rosario
Rosario, Santa Fe Province, Argentina
Grupo Medico Alem
Buenos Aires, Argentina
DIM Clinical Privada
Buenos Aires, Argentina
Clinica Medica Sin Internacion
Buenos Aires, Argentina
Fundación de Estudios Farmacológicos y de Medicamentos
Buenos Aires, Argentina
Universitaetsklinik Graz medizinische Universitaetsklinik;
Graz, Austria
LKH Salzburg Landesklinik fuer Innere Medizin I
Salzburg, Austria
Millergasse 7
Vienna, Austria
Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment
Vienna, Austria
...and 177 more locations
To evaluate the long-term efficacy of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.
Time frame: 76 weeks