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.

NCT03088670

Phase 3 Completed 299 enrolled SatRx LLC
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

EvaluationDrugModalityDoseRoute
Subject Gosogliptin Small molecule 30 mg Oral
Comparator Vildagliptin Other / unclassified 100 mg Oral
Background Metformin Small molecule 2000 mg Oral