Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Prospective, Multicenter, Randomized, and Comparative Clinical Trials to Compare the Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
Verified date | July 2022 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An exploratory comparison of changes in liver fibrosis through glycemic control within and between groups after administration of Pioglitazone and Evogliptin in chronic hepatitis B patients with type 2 diabetes and liver fibrosis
Status | Active, not recruiting |
Enrollment | 28 |
Est. completion date | February 19, 2023 |
Est. primary completion date | January 19, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - Adult aged 20 or over and under 80 years of age - Those who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes. first. For the first diagnosis of type 2 diabetes: 6.5% = HbA1c < 10.0%; second. Diagnosed with type 2 diabetes: HbA1c < 10.0%; - Subjects who show significant liver fibrosis of 7 kilopascal or more in liver elasticity test using Fibroscan. - Subjects who voluntarily sign the informed consent form after understanding the clinical study and being informed of the risks and benefits. Exclusion Criteria: - Those who are currently taking Pioglitazone or Evogliptin, or those who have stopped taking medication for less than 4 weeks. - Patients meeting the criteria for alcoholic fatty liver (if alcohol intake exceeds 210 g per week for men and 140 g per week for women for the past 2 years) - Cirrhosis patients with decreased liver function (CTP class B and C) - Those taking drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.) - Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis (within 24 weeks) - In case of allergy or hypersensitivity reaction to the target drug or its components. - Patients treated with oral or parenteral corticosteroids chronically (>14 consecutive days) within 8 weeks prior to screening - Malnutrition, starvation, and debilitating conditions (including patients with severe infections and severe trauma before and after surgery) - Patients receiving or receiving radiation and chemotherapy for malignancy for less than 2 years. - Heart failure (class III-IV in New York Heart Association classification) or uncontrolled arrhythmias within 24 weeks table. New York Heart Association Classification. Class I: Normal athletic ability; Class ?: Difficulty breathing, palpitations, chest pain, etc. appear due to daily exercise (fast walking or climbing a hill); Class ?: Symptoms appear with light exercise (walking on flat ground); Class IV: Symptoms appear even at rest; - Patients with acute cardiovascular disease within 12 weeks (patients with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or coronary intervention) - Patients with renal failure, chronic renal disease (estimated glomerular filtration rate <60 mL/min/1.73 m2) or patients on dialysis. - Anemic patients with an Hb level of less than 10.5 g/dl. - Pregnant or lactating women - Patients who do not consent to the use of appropriate contraceptive methods during the clinical trial period only for women or men of childbearing potential. - Patients who have taken clinical trial drugs from other clinical trials within 4 weeks of consenting to the document. - Persons unable to participate in clinical trials due to the judgment of other researchers. - Persons who cannot read consent forms (eg illiterate, foreigners, etc.) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | 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 |
Lead Sponsor | Collaborator |
---|---|
Seung Up Kim |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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