Type 2 Diabetes Mellitus Clinical Trial
Official title:
Mechanism of Reduced Response to DPP-4 Inhibitor in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to confirm the mechanism of reduced response to DPP-4 inhibitor in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-4 inhibitor
Sitagliptin, a DPP-4 inhibitor was used as an incretin enhancer in clinical practice first.
In clinical trials, sitagliptin showed effective control of blood glucose level in type 2
diabetes and 100 mg once daily with metformin was similar to sulfonylurea (glipizide) with
metformin in lowering HbA1c. Mostly in practice, stable blood glucose levels were maintained
after change of sulfonylurea to sitagliptin in type 2 diabetes treatment. However, in some
cases, there were abrupt severe hyperglycemia and uncontrolled blood glucose level after
drug change to sitagliptin.
Several mechanism could be considered for reduced response to DPP-4 inhibitor in some type 2
diabetes patients. Firstly, significantly reduced secretion of glucagon-like peptide 1
(GLP-1) more than expected in diabetes or functional defect of GLP-1 activity could be the
mechanism of loss of GLP-1 effect irrespective of DPP-4. Secondly, mutation or functional
defect of DPP-4 enzyme could not be inhibited by DPP-4 inhibitor. Thirdly, GLP-1 receptor
mutation or other defect in β-cell responsiveness to GLP-1 leads to reduction of response to
DPP-4 inhibitor.
;
Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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