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
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
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
Subjects who satisfy the selection/exclusion criteria and agree to participate in the clinical trial are randomly assigned to receive clinical trial drugs in a 1:1 ratio based on Visit 2 (Baseline) and take it for 24 weeks.
After that, visits are made at 12 and 24 weeks, and necessary tests are performed to confirm the improvement of liver fibrosis and to evaluate safety.
[Number of subjects and basis for calculation] The target number of test subjects is 40 in total, with 20 in each group (including 10% dropout rate).
The study design is an interventional study design comparing two test drugs, and it is intended to be performed as an exploratory study on safety and efficacy to confirm the possibility of entering a therapeutic confirmation trial.
The number of subjects was assumed by referring to the study on the measurement of liver fibrosis in NAFLD patients with type 2 diabetes in Reference which was conducted as hepatitis B patients with type 2 diabetes, the target disease of this clinical trial.
Significance level: 0.05 (two-sided test) statistical power: 90% Difference in the amount of change before and after treatment: 3.7 Standard deviation: 4.416324172 (Utilizing previous research results, the standard deviation of the difference was calculated by calculating the inverse function of the t distribution.)
G-power was used to calculate the number of subjects, and since this study is an exploratory comparative study between two groups and two independent groups, 18 people are needed per group, so a total of 36 people are needed. Considering dropout of about 10%, a total of 40 subjects, 20 in each group, will participate in this study.
[randomization] Randomization is based on a randomization table previously generated by a medical statistician. Therefore, the suitability of the subject is judged before the subject is randomly assigned to the two groups. Randomization will be conducted at a ratio of 1:1 to Test Group 1 and Test Group 2, respectively, based on the number of subjects for each clinical trial participating institution.
During clinical trial registration, subjects who have signed the consent form can only be identified with a unique subject identification code given to each subject instead of their name, and a random number will be continuously assigned by the researcher.
The randomization number is determined according to a computer-generated randomization code, and the randomization number determines the study drug group for the subject.
Randomization numbers are assigned sequentially according to the order of subject registration, and subjects will be continuously supplied with drugs based on the same dosing number during the clinical trial period.
Each Principal Investigator or Investigator shall check the randomization number assigned to each subject whenever a subject is enrolled in serial number order, and then start administration of the study drug accordingly. If a subject withdraws from the clinical trial, the randomization number assigned to the subject cannot be reused, and the subject cannot participate again in the trial.
Inclusion Criteria:
first. For the first diagnosis of type 2 diabetes: 6.5% ≤ HbA1c < 10.0%; second. Diagnosed with type 2 diabetes: HbA1c < 10.0%;
Exclusion Criteria:
table. New York Heart Association Classification. Class I: Normal athletic ability; Class Ⅱ: Difficulty breathing, palpitations, chest pain, etc. appear due to daily exercise (fast walking or climbing a hill); Class Ⅲ: Symptoms appear with light exercise (walking on flat ground); Class IV: Symptoms appear even at rest;