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The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin and metformin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teneligliptin 20 mg | Experimental | Once daily for 24 weeks |
|
| Teneligliptin placebo | Placebo Comparator | Once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet | Drug | To be orally administered once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline HbA1c at week 24 | Baseline (week 0) and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline FPG at week 24 | Baseline (week 0) and week 24 | |
| Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24 | Baseline (week 0) and week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Teneligliptin Placebo Oral Tablet | Drug | To be orally administered once daily |
|
| Changes from baseline in BMI at week 24 |
| Baseline (week 0) and week 24 |
| 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 |
|---|---|
| C579035 | 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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