drugset / Trial / NCT01910441

Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients

NCT01910441 ↗

Phase 4 Terminated 95 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.

Timeline

Start
2013-07
Primary completion
2014-09
Completion
2014-09

Outcome

Outcome not reported

Stopped: “The study was terminated due to the unavailability of Continuous Glucose Monitoring sensors (CGMS) which were required to assess the primary end-point.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glimepiride Small molecule 1 mg —
Comparator Glimepiride Small molecule 6 mg —
Subject Vildagliptin Other / unclassified 50 mg —
Background Metformin Small molecule 1000 mg —
Background Metformin Small molecule 1500 mg —