drugset / Trial / NCT03958591

Impact of Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification

NCT03958591

Phase 4 Completed 274 enrolled Yanbing Li
RandomizedParallel-groupOpen-labelTreatment

Summary

Despite advances in diabetes management, many patients with type 2 diabetes in China fail to achieve optimal glycemic control. One of the possible reasons is associated with the delay in therapeutic decision making that lags behind glycemic rise. The investigators design this study and presume that using vildagliptin and metformin in combination with basal insulin as sequential treatment after intensive insulin therapy, might better modulate the dual islet hormone dysfunction than traditionally stepwise upgrading therapy pattern in patients with poorly controlled T2DM, and thus lead to a glucose normalization, β-cell function improvement and therapy simplification.

Timeline

Start
2019-05-01
Primary completion
2025-01-01
Completion
2026-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 1 g Oral
Subject Metformin Small molecule 2 g Oral
Subject Vildagliptin Other / unclassified 100 mg Oral