Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| evogliptin 5mg | Experimental | evogliptin 5mg QD |
|
| placebo | Placebo Comparator | Placebo QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| evogliptin 5mg | Drug | evogliptin 5mg, QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | unit: % | Change from baseline at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| fasting plasma glucose | unit: mg/dL | Change from baseline at 24 weeks |
| HbA1c response rate | unit: % | Change from baseline at 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Doo Man Kim, M.D., Ph.D. | Kangdong Sacred Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangdong Sacred Heart Hospital | Seoul | 134-701 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C557982 | 4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo, QD |
|
| D004700 | Endocrine System Diseases |