None listed
Conditions
Interventions
carnitine orotate complex(brand name: GODEX cap.), 412mg/cap., 2cap. tid, peroral
2) Oral antidiabetics
All oral antidiabetics except for TZD(thiazolidinedione). No change in dosage and administration for diabetic medications.
2. Monotherapy treatment group
1) Placebo
412mg/cap., 2cap. tid, peroral
2) Oral antidiabetics
All oral antidiabetics except for TZD(thiazolidinedione). No change in dosage and administration for diabetic medications.
Sponsors
Celltrion Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age at least 20 year and under 70 years 2. Subjects with non-alcoholic fatty liver disease(NAFLD) at screening: 1) 50U/L = ALT = 250U/L and 2) subject was diagnosed with fatty liver in CT scan by radiologic imaging expert. 3. subject should be diagnosed with type 2 diabetes at least 3 months before prior to study entry and should be meet the below conditions. 1) 130mg/dL = fasting glucose = 300mg/dL or HbA1c = 6.5% at screening 2) No change in dosage and administration for diabetic medications during the treatment periods. 3) Must be willing to abide by the dietary and therapeutic exercise treatment for the diabetes control. 4. Informed consent
Exclusion criteria
Exclusion criteria: 1. Subject with allergy to study agents or their formulations 2. Chronic alcoholism 3. Subject with current viral hepatitis(HAV, HBV, HCV, etc.), alcoholic liver disease, drug or other liver injury that affects study results 4. Subject with taking oral antidiabetics of thiazolidinedione(TZD) 5. Subject with progressive disease such as malignant tumor 6. Subject with active bleeding 7. Pregnant or breastfeeding women 8. Subject who participated in any clinical studies within 90 days prior to study entry 9. Subject who has taken obesity treatment within 30 days prior to study entry 10. Subject with cardiopathy such as below severe heart diseases within 6 months prior to study entry - coronary artery bypass, blood vessel stents - acute myocardiac infarction - angina - congestive heart failure - unmodulated hypertension(BP > 180/110 mmHg) - unmodulated ventricular arrhythmia or arrhythmia requiring continuous treatment 11. Subject with inability or unwillingness to give informed consent or abide by the study protocol 12. Subject with whole body disorder that affects daily life(eg. COPD, chronic obstructive pulmonary disease) 13. Subject with unable and unwilling to comply with the informed consent process, to meet study requirements including following insturctions on study treatment, and to return for follow-up visits are required by the protocol. 14. Subject with disease histories such as drug abuse or alcoholism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of ALT normalization | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes and change rate of glycemic control (fasting glucose, fasting insulin, C-peptide, HbA1c);The changes of insulin resistance(HOMA-IR, beta);The changes of non-alcoholic fatty liver disease(CT, NFS; NAFLD fibrosis score);The evaluation of non-invasive arteriosclerotic degree(PWV; pulse wave velosity);The changes of waist circumference | — |
Countries
Korea, Republic of
Contacts
Public ContactMoon-Kyu Lee
Samsung Medical Center
Outcome results
None listed