Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: type 2 diabetes basal insulin vildagliptin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 42
Healthy volunteers: no

Brief summary:
To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.

Detailed description:
This study, conducted in T2DM patients failing a dual therapy with metformin/SU in whom the decision to start basal insulin has been taken, will compare vildagliptin+metformin versus the previously used SU+met combination (regimen kept unchanged) in association with basal insulin, up-titrated as per usual algorithms primarily based on FPG to obtain a similar improvement in glycemic control in both arms, on the incidence of hypoglycemic episodes over 24 weeks.

Arms:
arm 1: Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG arm 2: Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG

Interventions: intervention 1: Vildagliptin intervention 2: Metformin intervention 3: sulfonylurea (SU) intervention 4: Basal Insulin
Intervention descriptions: intervention 1: 50 mg b.i.d intervention 2: metformin is to be kept unchanged intervention 3: None intervention 4: None

Protocol document: