Status:
COMPLETED
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
Lead Sponsor:
Yonsei University
Conditions:
Type 2 Diabetes
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02285205
Start Date
November 1 2014
End Date
November 1 2015
Last Update
February 2 2016
Active Locations (1)
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1
Severance Hospital, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, Seoul, South Korea, 120-752