drugset / Trial / NCT03088670
Efficacy and Safety of Gosogliptin as Monotherapy and in Combination With Metformin vs. Vildagliptin as Monotherapy and in Combination With Metformin in Drug-naive Type 2 Diabetic Patients.
RandomizedParallel-groupOpen-labelTreatment
Summary
To demonstrate that efficacy of Gosogliptin as Monotherapy and in Combination with Metformin is non-inferior to efficacy of Vildagliptin as Monotherapy and in combination with Metformin in the effects on glycosilated hemoglobin (HbA1c) at Week 12 and Week 36 compared to baseline (Week 0).
Timeline
- Start
- 2013-04-23
- Primary completion
- 2014-03-30
- Completion
- 2014-10-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gosogliptin | Small molecule | 30 mg | Oral |
| Comparator | Vildagliptin | Other / unclassified | 100 mg | Oral |
| Background | Metformin | Small molecule | 2000 mg | Oral |