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The clinical study determines the effect of Evogliptin in patients with type 2 diabetes mellitus and chronic hepatitis B to confirm the improvement of hepatic fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Experimental |
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| Evogliptin | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gluconon tab 15mg | Drug | frosting and formulation : a round, convex tablet of white to gray. path of administration : once a day, two tabs, oral Amount of raw material medication (1 pill) : Pioglitazone hydrochloride 16.53mg storage method : Store 15 to 30°C to avoid light-tight containers and moisture manufacturing source : DONG-A ST |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days) | Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms | Baseline |
| Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days) | Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms | Baseline to 24 weeks (±7days) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline CAP (Controlled Attenuation Parameter) at week 24 (±7days) within and between arms | Change from baseline at Week 24 (±7days) is defined as [(Baseline CAP value) - (Follow-up CAP value)] / (Baseline CAP value) * 100 (%) | 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Changes from baseline HbA1c at week 24 (±7days) within and between arms |
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Inclusion Criteria:
Adultes between 20 and 80 years of age
Patients who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes
Patients who have significant liver fibrosis of at least 7 kPa in a hepaticity test using fibroscan
Patients who voluntarily signed the consent form after informed on the object, method, benefits and risks of the clinical study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung Up Kim | Contact | +82-2228-1982 | ksukorea@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Seung Up Kim | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Not yet recruiting | Seoul | South Korea |
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| suganon tab 5mg | Drug | frosting and formulation : pink circular film coating tablets path of administration : once a day, one tabs, oral Amount of raw material medication (1 pill) : Evogliptin tartrate 6.869mg(5mg as evogliptin) storage method : Confidential containers, stored at room temperature (1-30°C) manufacturing source : DONG-A ST |
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Change from baseline at Week 24 (±7days) is defined as HbA1c at Week 24 (±7days) minus HbA1c at Week 0 |
| 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Changes from baseline Insulin at week 24 (±7days) within and between arms | Change from baseline at Week 24 (±7days) is defined as insulin at Week 24 (±7days) minus insulin at Week 0 | 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Changes from baseline lipid profile (total cholesterol, HDL, LDL, TG) at week 24 (±7days) within and between arms | Change from baseline at Week 24 (±7days) is defined as lipid profile (total cholesterol, HDL, LDL, TG) at Week 24 (±7days) minus lipid profile at Week 0 | 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Changes from baseline AST/ALT at week 24 (±7days) within and between arms | Change form baseline at Week 24 (±7days) is defined as the proportion of AST/ALT values who are normalized at Week 24 (±7days) | 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Changes from baseline Body weight at week 24 (±7days) within and between arms | Change from baseline at Week 24 (±7days) is defined as body weight at Week 24 minus body weight at Week 0 | 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Changes from baseline Liver fibrosis and fatty liver at week 24 (±7days) among the MRE+MRI PDFF enforcement arms within and between arms | Change from baseline at Week 24 (±7days) is defined by MRE+MRI PDFF | 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Proportions of adverse effects and drug interruptions or changes between baseline and week 24 (±7days) within and between arms | Compare between baseline at Week 24 (±7days) is defined as the occurrence rate of adverse events and drug interruptions or changes | 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Prognostic factor of the Improvement of Liver fibrosis between baseline and week 24 (±7days) within and between arms | Prediction Factor Analysis of the Improvement of Liver fibrosis after 24 (±7days) weeks compared to Baseline within and between arms | 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Prognostic factor of the Improvement of Fatty liver between baseline and week 24 (±7days) within and between arms | Prediction Factor Analysis of the Improvement of Fatty liver after 24 weeks (±7days) compared to Baseline within and between arms | 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Prognostic factor of the Improvement of HbA1 between baseline and week 24 (±7days) within and between arms | Prediction Factor Analysis of the Improvement of HbA1c after 24 weeks (±7days) compared to Baseline within and between arms | 1) Baseline, 2) Baseline to 24 weeks (±7days) |
| Samsung Hospital | Recruiting | Seoul | South Korea |
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| Seoul National University Hospital | Not yet recruiting | Seoul | South Korea |
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| Yonsei Severance Hospital | Not yet recruiting | Seoul | South Korea |
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