drugset / Trial / NCT02343926

Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin

NCT02343926

Phase 3 Completed 443 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to metformin in terms of change in Hemoglobin A1c (HbA1c) reduction. Secondary Objectives: To compare the safety and tolerability of gemigliptin and vildagliptin: * Number of patients who experience at least one episode of hypoglycemia. * Number of patients experiencing adverse event (AE), serious adverse event (SAE). * Assessment of patients compliance defined as number tablets returned by patients.

Timeline

Start
2014-12
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemigliptin Small molecule Oral
Comparator Vildagliptin Other / unclassified Oral
Background Metformin Small molecule Oral