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This is a randomized, placebo-controlled clinical trial of Teneligliptin as quadruple oral combination therapy for type 2 diabetes after failure of an oral triple anti-diabetic regimen. Patients with uncontrolled type 2 diabetes (7.1% ≤ HbA1c ≤ 9%) prescribed with triple combination of oral antidiabetic drugs more than 12 weeks with sufficient doses (metformin >= 1000mg/d, Glimepiride >=4 mg/day, Gliclazide >= 60 mg/day, SGLT-2 inhibitor with approved dose by Korea FDA) will be included. Using randomization, patients would take either teneligliptin (20mg) or placebo for 12 weeks. After 12 weeks of trial, all patients would receive teneligliptin for another 12 weeks. As outcomes, changes in HbA1c and fasting plasma glucose at 12th and 24th weeks compared with at baseline, and proportions of patients who achieved a glycemic goal (HbA1c <=7%) at 12th and 24th weeks will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| teneligliptin | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teneligliptin | Drug | teneligliptin 20mg PO qd for 24weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hb1Ac | Difference between baseline and HbA1c at 12 weeks after treatment with test drug | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Difference between baseline and HbA1c at 24 weeks after treatment with test drug | 24 weeks |
| Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) | Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) at 12 and 24 weeks after treatment with the test drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Severance Hospital | Seoul | South Korea |
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| Placebo |
| Drug |
teneligliptin 20mg PO qd for 12weeks after placebo 1T PO qd for 12 weeks |
|
| 12 weeks |
| Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) | Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) at 12 and 24 weeks after treatment with the test drug | 24 weeks |
| Fasting glucose | Fasting blood glucose (FPG) at 12 and 24 weeks after treatment with test drug | 12 weeks |
| Fasting glucose | Fasting blood glucose (FPG) at 12 and 24 weeks after treatment with test drug | 24 weeks |
| 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 |
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