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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02285205
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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 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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Non-alcoholic Fatty Liver Disease Drug: Oral administration of Lobeglitazone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015


Arm Intervention/treatment
Experimental: Lobeglitazone Drug: Oral administration of Lobeglitazone
Lobeglitazone 0.5mg/tablet, orally, 1 tablet once daily for 24 weeks




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type Ⅱ diabetes mellitus
  2. Non-alcoholic fatty liver disease: subjects who have CAP(Controlled Attenuation Parameter) ≥ 250dB/m measured by transient elastography (fibroscan) at screening test
  3. Age ≥ 20 years
  4. 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
  5. Agreement with written informed consent

Exclusion Criteria:

  1. Patients whose alcohol consumption >210g/week for males and 140g/week for females
  2. chronic B viral hepatitis, chronic C viral hepatitis, Type I diabetes, or secondary diabetes
  3. having a history of acute or chronic metabolic acidosis including diabetic ketoacidosis
  4. patients who have been taking other oral hypoglycemic agents except metformin or insulin within recent 8 weeks
  5. who experienced hypersensitivity reaction against metformin or glitazone drugs
  6. who has been treated with corticosteroids for at least 14 days within 2 month prior to Screening
  7. having a history of lactic acidosis
  8. having genetic predispositions such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  9. who are in condition of malnutrition, starvation, cachexia, severe infection, major trauma, hypopituitarism, or adrenal insufficiency
  10. diagnosed with cancer within 2 years or having chemo or radiotherapy for cancer treatment
  11. a history of drug abuse or chronic alcoholism
  12. a history of heart failure (NYHA class III and IV) or uncontrolled arrhythmia
  13. 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)
  14. Renal dysfunction: Serum creatinine greater than 1.5mg/dl for males and 1.4mg/dl for females.
  15. Anemia less than 10.5g/dl for any reason
  16. Pregnant women or nursing mothers
  17. Fertile women who not practice contraception with appropriate methods
  18. in treatment concomitant drug from other clinical trials within 4 weeks from enrollment
  19. who did not agree with written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285205


Locations
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Korea, Republic of
Severance Hospital, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02285205    
Other Study ID Numbers: 4-2014-0778
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases