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To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemigliptin + Metformin | Experimental | Gemigliptin 50 mg + Metformin 500 mg to 1000mg for 12 weeks |
|
| Sitagliptin + Metformin | Active Comparator | Sitagliptin 100 mg + Metformin 500 mg to 1000mg for 12 weeks |
|
| Glimepiride + Metformin | Active Comparator | Glimepiride 2 mg + Metformin 500 mg to 1000mg for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Amplitude Glycemic Excursion | Change of MAGE at Week 12 from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon | Change of Glucagon at Week 12 from baseline | |
| Active GLP-1 | Change of Active GLP-1 at Week 12 from baseline | |
| CRP |
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Inclusion Criteria:
Patients with Type 2 Diabetes Mellitus
adults aged ≥ 20 and aged ≤ 70 years old
Patients who had not taken anti diabetes drug for 8 weeks prior to screening visit with HbA1c ≥ 7.5%
All patients give written informed consent
Patients applicable to any one of following 3 categories
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SE Park | Kangbuk Samsung Hospital | Principal Investigator |
| BW Lee | Severance Hospital | Principal Investigator |
| JH Jo | Seoul St. Mary's Hospital | Principal Investigator |
| JH Kim | Samsung Medical Center | Principal Investigator |
| JH Jung | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Seoul | 120-752 | South Korea |
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| Change of CRP at Week 12 from baseline |
| Nitrotyrosine | Change of nitrotyrosine at Week 12 from baseline |
| Glycated albumin | Change of glycated albumin at Week 4 from baseline |
| Fructosamine | Change of fructosamine at Week 4 from baseline |
| Glucose Standard Deviation in CGMS data | Change of Glucose SD at Week 12 from baseline |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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 |
|---|---|
| C534891 | LC15-0444 |
| D008687 | Metformin |
| D000068900 | Sitagliptin Phosphate |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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