Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Phase 2

Completed

Interventions: Drug: Vildagliptin
Drug: Sitagliptin
Drug: Metformin
Drug: Placebo

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

Patients 18-78 years old inclusive at Visit 1
T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1
Patient agreement to maintain same dose of metformin throughout study
HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1

Exclusion Criteria

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
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	24 weeks

Secondary Outcome Measures

Name	Time	Method
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.	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.	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.	76 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.	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.	24 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.	24 weeks
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.	76 weeks

Locations (183): Instituto de Investigaciones Biomedicas
🇦🇷
Buenos Aires, Santa Fe, Argentina
Grupo Colaborative Rosario
🇦🇷
Rosario, Santa Fe, Argentina
Fundación de Estudios Farmacológicos y de Medicamentos
🇦🇷
Buenos Aires,, Argentina
Grupo Medico Alem
🇦🇷
Buenos Aires, Argentina
DIM Clinical Privada
🇦🇷
Buenos Aires, Argentina
Clinica Medica Sin Internacion
🇦🇷
Buenos Aires, Argentina
Universitaetsklinik Graz medizinische Universitaetsklinik;
🇦🇹
Graz, Austria
LKH Salzburg Landesklinik fuer Innere Medizin I
🇦🇹
Salzburg, Austria
Kindlergasse 4
🇦🇹
Wiener Neustadt, Austria
Millergasse 7
🇦🇹
Wien, Austria
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Instituto de Investigaciones Biomedicas
🇦🇷Buenos Aires, Santa Fe, Argentina