It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels in both fasting and postprandial states and preserves pancreatic beta cell function in patients with type 2 diabetes. Their mechanism of action is derived from increased incretin (GLP-1) levels, which stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas. Recent studies reported that combination therapy with DPP-IV inhibitors and metformin have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. However, there have been few studies about the difference of glucose lowering effect of combination therapy of DPP-IV inhibitors and metformin according to the secretory capacity of pancreas. The researchers hypothesized that combination therapy with DPP-IV inhibitor and metformin may have more favorable glucose lowering effect in type 2 diabetic patients who have preserved pancreatic secretory function. The researchers plan to investigate the difference of glucose lowering effect of 24 weeks treatment with sitagliptin (DPP-IV inhibitor) in combination with metformin according to basal c-peptide and glucagon level in type 2 diabetic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The change of HbA1c
Time frame: 52 weeks
Fasting Plasma Glucose (FPG)
Time frame: 52 weeks
Postprandial Plasma Glucose (PPG)
Time frame: 52 weeks
C-peptide
Time frame: 52 weeks
Glucagon
Time frame: 52 weeks
Homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: 52 weeks
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