Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Evaluate 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.
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).
- Screening of patients at Week -2
- Training for all complying patients in Diabetes Program School at Week -1 with
glucometer and patient diary distribution for SMBG
- Randomization in one of two groups in the ratio 1:1.
- The 1st stage includes 12 weeks of monotherapy with Gosogliptin or Vildagliptin.
- The 2nd stage includes 24 weeks of combination therapy with Gosogliptin and Metformin
or Vildagliptin and Metformin.
- Follow-up period of 4 weeks.
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