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The objective of this study is to evaluate efficacy and safety of initial combination therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment naïve patients with type 2 diabetes, In other words, to proof superiority of initial combination therapy with Gemigliptin and Metformin than each monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental | Gemigliptin 50mg + Metformin Once daily with dinner |
|
| Arm 2 | Experimental | Gemigliptin 50mg + Placebo(Metformin)Once daily with dinner |
|
| Arm3 | Experimental | Metformin+ Placebo(Gemigliptin 50mg)Once daily with dinner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin 50mg | Drug |
| ||
| Placebo(Metformin) |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Evaluation variables at week 24 to baseline(Visit 2(randomization), week 0) | 24weeks |
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Inclusion Criteria:
Patients with type 2 diabetes mellitus
Adults over 20 of age
Patients with hemoglobin A1c (HbA1c) over 7.5% at Visit1(screening) and no previous antidiabetic drugs before Visit 1(screening) or patients with hemoglobin A1c (HbA1c) between 7%~10.5%, Patients treated with metformin monotherapy before Visit 1(screening).
Patients with no previous antidiabetic drugs
Patients with hemoglobin A1c (HbA1c) between 7.5%~11% at Visit 2(randomization)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LG Life Sciences | Seoul | 110-062 | South Korea |
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|
| Metformin | Drug |
|
| Placebo(Gemigliptin) | Drug |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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 |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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