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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Non-Alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral administration of Lobeglitazone

Drug

Lobeglitazone 0.5mg/tablet, orally, 1 tablet once daily for 24 weeks

Primary outcomes

changes from baseline in controlled attenuation parameters (CAP)

Time frame: 24 weeks

Changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 6, 2014
Registry last updated: Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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