drugset / Trial / NCT01238978

Phase 4 Study in the Elderly Patients With T2DM

NCT01238978 ↗

Phase 4 Completed 46 enrolled Novartis
RandomizedParallel-groupOpen-labelTreatment

Summary

The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin

Timeline

Start
2010-10
Primary completion
2011-12
Completion
2011-12

Outcome

Met primary endpoint

paper The incidence of hypoglycaemia/severe hypoglycaemia was significantly higher over 6months in the COAD cohort (20.1%/2.4% vs. 6.4%/0.1%; P<0.001) PMID 22996038 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vildagliptin Other / unclassified — —