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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

Primary Purpose

Type 2 Diabetes, Non-alcoholic Fatty Liver Disease

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Oral administration of Lobeglitazone

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lobeglitazone

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02285205

First Posted

November 4, 2014

Last Updated

January 31, 2016

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02285205

Brief Title

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 Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Non-alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lobeglitazone

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Oral administration of Lobeglitazone

Intervention Description

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

Primary Outcome Measure Information:

Title

changes from baseline in controlled attenuation parameters (CAP)

Description

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

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

27914133

Citation

Lee YH, Kim JH, Kim SR, Jin HY, Rhee EJ, Cho YM, Lee BW. Lobeglitazone, a Novel Thiazolidinedione, Improves Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes: Its Efficacy and Predictive Factors Related to Responsiveness. J Korean Med Sci. 2017 Jan;32(1):60-69. doi: 10.3346/jkms.2017.32.1.60.

Results Reference

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