A study to compare combination regimen with vildagliptin & metformin versus metformin in treatment-naive patients with type 2 diabetes mellitus

Update Il y a 4 ans
Reference: EUCTR2011-003712-23

Woman and Man

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Extract

- Demonstrate the superiority of combination of vildagliptin 50mg bid and metformin over metformin monotherapy in treatment-naive patients with T2DM by testing the hypothesis that the risk of initial treatment failure (defined as HbA1c ≥ 7.0%) is lower with the combination of vildagliptin and metformin compared to that with metformin monotherapy - Demonstrate the long-term efficacy of combination of Vildagliptin 50mg bid and metformin over metformin monotherapy in treatment-naive patients with T2DM by testing the hypothesis that the rate of loss in glycemic control over time (estimated annualized slope of HbA1c over time using a random coefficient model) is lower with the combination vildagliptin plus metformin compared to that with metformin monotherapy


Inclusion criteria

  • Type 2 diabetes mellitus