Efficacy and Long-Term Safety of Vildagliptin as Add-on T... | NCT00860288 | Trialant

Efficacy and Long-Term Safety of Vildagliptin as Add-on T... | NCT00860288 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vildagliptin Dose 1	Experimental		Drug: Vildagliptin Drug: Metformin
Vildagliptin Dose 2	Experimental		Drug: Vildagliptin Drug: Metformin
Placebo	Placebo Comparator		Drug: Metformin Drug: Placebo
Sitagliptin	Active Comparator		Drug: Metformin Drug: Sitagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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 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.

Contacts/Locations Module

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D014230	Triazoles
D001393	Azoles
D011719	Pyrazines