Type 2 Diabetes Mellitus Clinical Trial
Official title:
A 24-week, Open-label, Randomized, Multi-center, Parallel-group Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Prior Metformin Monotherapy in Comparison to up Titrating Metformin Dose.
The study design of this trial is open-label, randomized, multi-center, parallel-group study.
- The progressive nature of T2DM will require the use of combination therapy in many
patients over time to achieve and maintain glycemic control. Early combination,
compared with maximal dose of monotherapy, could be more effective in lowering glycemia
with better tolerability.
- Vildagliptin is a new oral antidiabetic drug acting as a potent and selective inhibitor
of dipeptidyl peptidase-4(DPP-4), the enzyme responsible for the rapid degradation of
circulating glucagon-like peptide-1. Vildagliptin improves islet function by a
mechanism of increasing plasma levels of the active forms of the incretin hormones,
GLP-1 and GIP.
- Metformin improves hyperglycemia primarily through its suppression of hepatic
gluconeogenesis as well as enhancement of peripheral glucose update. Metformin is the
most commonly prescribed first-line antidiabetic drug worldwide, but due to the
progressive worsening of blood glucose control during the natural history of type 2
diabetes, combination therapy usually becomes necessary.
- Thus their combination therapy with complimentary action mechanism could be as
effective as up titration of monotherapy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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