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It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas by increasing incretin (GLP-1) levels. Recent studies reported that combination therapy with DPP-IV inhibitors and other oral antidiabetic medication 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 glucose lowering effect of DPP-IV inhibitors in patients with type 2 diabetes on insulin treatment.
The researchers hypothesized that DPP-IV inhibitor add-on therapy to insulin treatment may have favorable effects on glucose control and endogenous insulin secretory function in type 2 diabetic patients. The researchers plan to compare between sitagliptin (DPP-IV inhibitor) add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sitagliptin | Experimental |
| |
| insulin dose increase | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin | Drug | sitagliptin 100mg once daily, orally, for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of HbA1C | 24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the number of patients in HbA1C <7% without hypoglycemia | 24 weeks | |
| hypoglycemia(symptoms consistent with hypoglycemia and confirmed by plasma glucose < 72 mg/dL) | 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea | ||
| Seoul National University Bundang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22443183 | Derived | Hong ES, Khang AR, Yoon JW, Kang SM, Choi SH, Park KS, Jang HC, Shin H, Walford GA, Lim S. Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study. Diabetes Obes Metab. 2012 Sep;14(9):795-802. doi: 10.1111/j.1463-1326.2012.01600.x. Epub 2012 Apr 18. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| 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 |
| D049528 | Insulin, Long-Acting |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| insulin dose increase | Drug | insulin dose increase |
|
|
| the change of C-peptide |
| 24 weeks |
| the change of body weight and waist circumference | 24 weeks |
| the change of insulin dose | 24 weeks |
| Seongnam |
| South Korea |
| D006946 | Hyperinsulinism |
| D011719 |
| Pyrazines |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |