drugset / Trial / NCT01871558

Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

NCT01871558 ↗

Phase 3 Completed 42 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-06
Primary completion
2015-02
Completion
2015-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Metformin/Vildagliptin + Basal Insulin vs SU+Metformin + Basal Insulin; p = 0.139; Chi-squared NCT01871558 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vildagliptin Other / unclassified 50 mg —
Background Metformin Small molecule — —