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

• Status: Completed
• Trial end date: 2016-04-01

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.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Metformin; Vildagliptin