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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin+Sitagliptin | Experimental | Initial combination of metformin and sitagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin, metformin | Drug | sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of HbA1c | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose (FPG) | 52 weeks | |
| Postprandial Plasma Glucose (PPG) | 52 weeks | |
| C-peptide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo Lim, MD, MPH, PHD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 52 weeks |
| Glucagon | 52 weeks |
| Homeostatic model assessment of insulin resistance (HOMA-IR) | 52 weeks |
| D011719 |
| Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |