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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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
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
Gangnam Severance Hospital
Seoul, South Korea
NOT_YET_RECRUITINGSamsung Hospital
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
NOT_YET_RECRUITINGChanges 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
Time frame: 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
Time frame: Baseline to 24 weeks (±7days)
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 (%)
Time frame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline HbA1c at week 24 (±7days) within and between arms
Change from baseline at Week 24 (±7days) is defined as HbA1c at Week 24 (±7days) minus HbA1c at Week 0
Time frame: 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
Time frame: 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
Time frame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
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Yonsei Severance Hospital
Seoul, South Korea
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1) Baseline, 2) Baseline to 24 weeks (±7days)