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A multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and non-alcoholic fatty liver diseases
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evogliptin | Experimental | evogliptin 5mg |
|
| Pioglitazone | Active Comparator | pioglitazone 15mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evogliptin | Drug | evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline intrahepatic fat (%) | Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung Wan Lee | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Changwon | South Korea | ||||
| Soonchunhyang University Hospital |
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| Pioglitazone | Drug | pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd |
|
|
| Cheonan |
| South Korea |
| Keimyung Dongsan University Medical Center | Daegu | South Korea |
| Hanyang University Guri Hospital | Guri-si | South Korea |
| Catholic University of Seoul ST.Mary's Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C557982 | 4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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