Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Randomized, Parallel-group, Open Study to Compare the Efficacy and Safety of Early Combination Therapy With Amaryl M to Metformin Uptitration in Type 2 DM Patients Inadequately Controlled on Metformin HCL
The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin.
Treatment algorithms for type 2 DM generally employ monotherapy as a first-line
pharmacologic treatment option. Disease progression renders monotherapy less effective in
controlling blood glucose over time, with approximately half of the patients requiring
additional therapy by 3 years after diagnosis. As a result, the use of multiple
pharmacologic agents to control blood glucose is well accepted.
In combination therapy, selection of suitable drug may be individualized depending on their
health conditions. However, it is advisable to select drugs having different mechanism
considering their complimentary action with each other. Therefore, sulfonylureas and
metformin HCL is the best combination in which "insulin deficiency" and "insulin
resistance", the basic two pathophysiologies in type 2 diabetes could be targeted. The
efficacy and safety of the combination with sulfonylureas and metformin HCL have been proven
in numerous clinical studies as combination is more effective than monotherapy using each
drug in blood glucose control.
Also, new approaches are required in order to attain and maintain good glycaemic control
over time and aggressive earlier introduction of combination therapy is being increasingly
recommended over conventional stepwise strategies.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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