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Clinical Trial Details

Trial ID: L4616
Source ID: NCT05473806
Associated Drug: Pioglitazone 15 Mg Oral Tablet
Title: Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Hepatitis B, Chronic|Fibrosis, Liver|Diabetes Mellitus, Type 2
Interventions: DRUG: Pioglitazone 15 Mg Oral Tablet|DRUG: Evogliptin 5mg
Outcome Measures: Primary: Changes in Liver Stiffness Measurement at 24 weeks compared to baseline., It is measured based on the CAP score(db/m) and kilopascal from the liver fibroscan and evaluated by performing the paired-sample t-test or Wilcoxon signed test., 24 weeks | Secondary: Changes in Controlled Attenuation Parameter(CAP) value at 24 weeks compared to baseline., The rate of decrease in the amount of fatty liver (CAP Value) measured at the end of the evaluation compared to the baseline is a descriptive statistic defined as \[(Baseline CAP Value)- (Follow-up CAP Value)\] / (Baseline CAP Value) × 100 (%) (mean, standard deviation, median, range (minimum, maximum)) are presented., 24 weeks|Changes in HbA1c at 24 weeks compared to baseline., After 24 weeks of treatment, the degree of change in HbA1c compared to baseline is defined as absolute difference = \[= (Baseline HbA1c)-(Follow-up HbA1c)\] and evaluated by performing paired-sample t-test or Wilcoxon signed-rank test., 24 weeks|Changes in Insulin at 24 weeks compared to baseline., After 24 weeks of treatment, the degree of change in Insulin compared to baseline is defined as absolute difference = \[= (Baseline Insulin)-(Follow-up Insulin)\] and evaluated by performing paired-sample t-test or Wilcoxon signed-rank test., 24 weeks|Changes in lipid profile at 24 weeks compared to baseline., After 24 weeks of treatment, the degree of change in lipid profile compared to baseline is defined as absolute difference = \[= (Baseline lipid profile)-(Follow-up lipid profile)\] and evaluated by performing paired-sample t-test or Wilcoxon signed-rank test., 24 weeks|Changes in aspartate aminotransferase(AST)/alanine aminotransferase(ALT) at 24 weeks compared to baseline., It is evaluated by performing paired-sample t-test or Wilcoxon signed rank test. The proportion of subjects whose aspartate aminotransferase(AST)/alanine aminotransferase(ALT) recovered to normal values compared to baseline was Frequency and percentages are given and assessed using either the chi-square test or Fisher's exact test., 24 weeks|Changes in Body weight at 24 weeks compared to baseline., It is evaluated by performing paired-sample t-test or Wilcoxon signed rank test., 24 weeks|Rate of side effects and discontinuation or change of drug after 24 weeks compared to baseline, It is evaluated by performing paired-sample t-test or Wilcoxon signed rank test., 24 weeks|Analysis of predictors of improvement in liver fibrosis after 24 weeks compared to baseline., It is analyzed the subject's fibroscan(CAP score(db/m) and kilopascal), body weight, aminotransferase(AST)/alanine aminotransferase(ALT), lipid profile, hepatitis serum markers(Hepatitis B surface antigen(HBsAg),Hepatitis B e-antigen(HBeAg),Anti-Hepatitis B e-antigen(Anti-HBe),Anti-Hepatitis B surface antigen(Anti-Hbs),Anti-hepatitis C virus(Anti-HCV)), drug compliance., 24 weeks|Analysis of predictors of improvement of fatty liver after 24 weeks compared to baseline., It is analyzed the subject's fibroscan(CAP score(db/m) and kilopascal), body weight, aminotransferase(AST)/alanine aminotransferase(ALT), lipid profile, hepatitis serum markers(Hepatitis B surface antigen(HBsAg),Hepatitis B e-antigen(HBeAg),Anti-Hepatitis B e-antigen(Anti-HBe),Anti-Hepatitis B surface antigen(Anti-Hbs),Anti-hepatitis C virus(Anti-HCV)), drug compliance., 24 weeks|Analysis of predictors of HbA1c improvement after 24 weeks compared to baseline., It is analyzed the subject's fibroscan(CAP score(db/m) and kilopascal), body weight, Homeostatic Model Assessment for Insulin Resistance, drug compliance., 24 weeks
Sponsor/Collaborators: Sponsor: Seung Up Kim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-09-18
Completion Date: 2023-02-19
Results First Posted:
Last Update Posted: 2022-07-26
Locations: Gangnam Severance Hospital, Seoul, Korea, Republic of|Samsung seoul Hospital, Seoul, Korea, Republic of|Seoul National University Hospital, Seoul, Korea, Republic of|Severance Hospital, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05473806