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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemigliptin | Small molecule | — | Oral |
| Comparator | Vildagliptin | Other / unclassified | — | Oral |
| Background | Metformin | Small molecule | — | Oral |