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| Name | Class |
|---|---|
| JW Pharmaceutical | INDUSTRY |
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Explore pharmacodynamics
Assess Safety
Pharmacodynamic assessment
CGMS data is obtained from day 1 to day 3 (48 hours)
PD is measured before (day 1) and after drug administration (day 2)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Active Comparator |
| |
| Mitiglinide | Active Comparator |
| |
| Sitagliptin + Mitiglinide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Single oral administration of sitagliptin 100 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (area under the curve) of plasma glucose | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period |
| AUC of insulin | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period |
| AUC of intact GLP-1 | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period |
| AUC of C-peptide | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period |
| AUC of glucagon | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period |
| MAGE | Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period |
| AUC of DPP-4 activity | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wooseong Hur, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24249434 | Derived | Jung JA, Kaku K, Kim JH, Kim JR, Ko JW, Lee SY, Huh W. Additive postprandial glucose-lowering effects of mitiglinide and sitagliptin in patients with type 2 diabetes mellitus. Adv Ther. 2013 Nov;30(11):1018-29. doi: 10.1007/s12325-013-0072-x. Epub 2013 Nov 19. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| C087255 | mitiglinide |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Mitiglinide |
| Drug |
Single oral administration of mitiglinide 10 mg |
|
| Sitagliptin, Mitiglinide | Drug | Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg |
|
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |