A 24 Week, Multicenter, Prospective, Open-labeled, Single-arm, Exploratory Phase 4 Clinical Trial to Evaluate the Safety and Efficacy of Lobeglitazone in Decreasing Intrahepatic Fat Contents in Type 2 Diabetes With NAFLD

Study Overview
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Brief Summary
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Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It demonstrates that Lobeglitazone improves even more glycemic and lipid control in comparison to rosiglitazone and pioglitazone. Currently, thiazolidinediones such as pioglitazone is the only drug which is considered as an effective therapeutic agent for improving non-alcoholic fatty liver disease (NALFD) in type 2 diabetes (T2D). The aim of this multicenter, prospective, open-labeled, single-arm, exploratory phase 4 study is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on intrahepatic fat contents assessed by transient elastography (fibroscan) in T2D with NAFLD. Fifty subjects with T2D and NAFLD will take Lobeglitazone (0.5mg/tablet, orally, 1 tablet once daily) for 24 weeks. Primary endpoint is changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone. Secondary endpoints are changes from baseline in glycemic profiles (HbA1c, Glycated albumin), Lipid parameters (Total Cholesterol, Triglycerides, HDL-C, LDL-C), Liver function parameters (AST, ALT, r-GT), and adverse events during the trial.

Conditions
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Type 2 Diabetes, Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: Oral administration of Lobeglitazone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type Ⅱ diabetes mellitus Non-alcoholic fatty liver disease: subjects who have CAP(Controlled Attenuation Parameter) ≥ 250dB/m measured by transient elastography (fibroscan) at screening test Age ≥ 20 years Patients who have not been taking any oral hypoglycemic agent for more than 12 weeks with HbA1c 7.0 to 8.5% at screening test or who have been taking metformin monotherapy for at least 8 weeks with HbA1c 7 to 9% at screening test Agreement with written informed consent Exclusion Criteria: Patients whose alcohol consumption >210g/week for males and 140g/week for females chronic B viral hepatitis, chronic C viral hepatitis, Type I diabetes, or secondary diabetes having a history of acute or chronic metabolic acidosis including diabetic ketoacidosis patients who have been taking other oral hypoglycemic agents except metformin or insulin within recent 8 weeks who experienced hypersensitivity reaction against metformin or glitazone drugs who has been treated with corticosteroids for at least 14 days within 2 month prior to Screening having a history of lactic acidosis having genetic predispositions such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption who are in condition of malnutrition, starvation, cachexia, severe infection, major trauma, hypopituitarism, or adrenal insufficiency diagnosed with cancer within 2 years or having chemo or radiotherapy for cancer treatment a history of drug abuse or chronic alcoholism a history of heart failure (NYHA class III and IV) or uncontrolled arrhythmia a history of acute cardiovascular or cerebrovascular disease within 12 weeks prior to Screening (unstable angina, myocardial infarction, transient ischemic attack, cerebral infarct, cerebral hemorrhage, coronary bypass, percutaneous coronary intervention) Renal dysfunction: Serum creatinine greater than 1.5mg/dl for males and 1.4mg/dl for females. Anemia less than 10.5g/dl for any reason Pregnant women or nursing mothers Fertile women who not practice contraception with appropriate methods in treatment concomitant drug from other clinical trials within 4 weeks from enrollment who did not agree with written informed consent

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lobeglitazone<br> | Drug: Oral administration of Lobeglitazone<br>* Lobeglitazone 0.5mg/tablet, orally, 1 tablet once daily for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes from baseline in controlled attenuation parameters (CAP) | Changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone | 24 weeks |