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Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects (LIGHT-ON)

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Liraglutide combined with metformin

Insulin glargine combined with metformin

Sitagliptin combined with metformin

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Non-alcoholic fatty liver disease, Glucagon-like peptide-1 receptor agonists, Diabetes mellitus, type 2

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Recorded Type 2 diabetes diagnosed at least 3 months before the study; At least 3 months treatment on a stable dose（≧1500mg/d）of metformin before the study
6.5%<HbA1c ≤10%
Clinically diagnosed simple liver steatosis
30-75 years old
Female subjects should be postmenopausal, surgically sterile, or using contraceptives for 3 months before screening and continuing throughout the study;
BMI 20~35 kg/m2 and with a history of stable body weight (≤10%variation for ≥3 months)
intrahepatic lipids (IHL) >10%

Exclusion Criteria:

Type 1 diabetes
Treatment within the last 3 months with Thiazolidinediones(TZDs), orlistat, insulin, any history of incretin based therapy or any other drugs associated with hepatic steatosis (including but not limited to glucocorticoids, tamoxifen, amiodarone or methotrexate)
History or current episode of pancreatitis or other disease of the pancrea; Impaired liver function, defined as plasma alanine transaminase(ALT) >2.5 times of upper normal limit
Moderate and severe renal insufficiency defined as MDRD formula glomerular filtration rate<60ml/min/1.73m2
Weekly alcohol intake>14 units for women or >21 units for men
Any history of liver disease including metabolic or auto-immune liver diseases or viral hepatitis
History or family history of medullary thyroid cancer(MTC), or multiple endocrine neoplasia type 2(MEN-2)
Congestive heart failure(NYHA III~IV)
Severe gastric-intestinal diseases
Pregnancy and/or intention of becoming pregnant
Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator; Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content. Herbal traditional Chinese medicine or other local herbal medicines may, at the Investigator's discretion, be continued throughout the trial at an unchanged dose

Sites / Locations

The Third Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Liraglutide

Insulin glargine

Sitagliptin

Arm Description

Liraglutide combined with metformin

Insulin glargine combined with metformin

Sitagliptin combined with metformin

Outcomes

Primary Outcome Measures

Intrahepatic lipids (IHL)

To compare the change of intrahepatic lipids (IHL) in type 2 diabetic patients with non-alcoholic fatty-liver disease after a 26-week treatment of liraglutide, sitagliptin or insulin glargine per day combined with metformin.

Secondary Outcome Measures

Change of abdominal subcutaneous adipose tissue(SAT)

To compare the change of SAT in type 2 diabetic patients

Change of visceral adipose tissue(VAT)

To compare the change of VAT in type 2 diabetic patients

Change in hemoglobin A1c(HbA1c)

To compare the change of HbA1c in type 2 diabetic patients

Full Information

NCT ID

NCT02147925

First Posted

May 16, 2014

Last Updated

May 17, 2018

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02147925

Brief Title

Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects

Acronym

LIGHT-ON

Official Title

Efficacy of Liraglutide vs. Sitagliptin vs. Insulin Glargine Per Day on Liver Fat When Combined With Metformin in T2DM Subjects With Non-alcoholic Fatty-liver Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to explore the effectiveness of liraglutide combined with metformin in non-alcoholic fatty-liver disease patients with type 2 diabetes mellitus (T2DM) compared to sitagliptin and insulin glargine in combination with metformin.

Detailed Description

This is a 26-week, randomized, open-label, active controlled, parallel group, multi-centre trial.To compare the change of intrahepatic lipids (IHL) as measured by magnetic resonance spectroscopy(MRS) or MRI estimated proton density fat fraction (MRI-PDFF) as measured by MRI IDEAL IQ (Iterative Decomposition of water andfat with Echo Asymmetryand Least-squares estimation) in type 2 diabetic patients with non-alcoholic fatty-liver disease after a 26-week treatment of liraglutide, sitagliptin or insulin glargine per day combined with metformin.The primary endpoint will be defined by intrahepatic lipids (IHL) as measured by magnetic resonance spectroscopy (MRS) or MRI-PDFF as measured by MRI IDEAL IQ.

6. Conditions and Keywords

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

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic fatty liver disease, Glucagon-like peptide-1 receptor agonists, Diabetes mellitus, type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liraglutide

Arm Type

Active Comparator

Arm Description

Liraglutide combined with metformin

Arm Title

Insulin glargine

Arm Type

Active Comparator

Arm Description

Insulin glargine combined with metformin

Arm Title

Sitagliptin

Arm Type

Active Comparator

Arm Description

Sitagliptin combined with metformin

Intervention Type

Drug

Intervention Name(s)

Liraglutide combined with metformin

Other Intervention Name(s)

Victoza®, Novo Nordisk

Intervention Description

Liraglutide, 0.6mg per day for the first week, and will be increased to 1.2mg per day for the second week, and finally 1.8mg per day since the third week

Intervention Type

Drug

Intervention Name(s)

Insulin glargine combined with metformin

Other Intervention Name(s)

Lantus®, Sanofi

Intervention Description

The initial dose will be 0.2 unit/kg/d

Intervention Type

Drug

Intervention Name(s)

Sitagliptin combined with metformin

Other Intervention Name(s)

Januvia®, Merck & Co. Inc.

Intervention Description

The dose throughout the study will be 100mg per day.

Primary Outcome Measure Information:

Title

Intrahepatic lipids (IHL)

Description

Time Frame

26-week

Secondary Outcome Measure Information:

Title

Change of abdominal subcutaneous adipose tissue(SAT)

Description

To compare the change of SAT in type 2 diabetic patients

Time Frame

26 weeks

Title

Change of visceral adipose tissue(VAT)

Description

To compare the change of VAT in type 2 diabetic patients

Time Frame

26 weeks

Title

Change in hemoglobin A1c(HbA1c)

Description

To compare the change of HbA1c in type 2 diabetic patients

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Recorded Type 2 diabetes diagnosed at least 3 months before the study; At least 3 months treatment on a stable dose（≧1500mg/d）of metformin before the study 6.5%<HbA1c ≤10% Clinically diagnosed simple liver steatosis 30-75 years old Female subjects should be postmenopausal, surgically sterile, or using contraceptives for 3 months before screening and continuing throughout the study; BMI 20~35 kg/m2 and with a history of stable body weight (≤10%variation for ≥3 months) intrahepatic lipids (IHL) >10% Exclusion Criteria: Type 1 diabetes Treatment within the last 3 months with Thiazolidinediones(TZDs), orlistat, insulin, any history of incretin based therapy or any other drugs associated with hepatic steatosis (including but not limited to glucocorticoids, tamoxifen, amiodarone or methotrexate) History or current episode of pancreatitis or other disease of the pancrea; Impaired liver function, defined as plasma alanine transaminase(ALT) >2.5 times of upper normal limit Moderate and severe renal insufficiency defined as MDRD formula glomerular filtration rate<60ml/min/1.73m2 Weekly alcohol intake>14 units for women or >21 units for men Any history of liver disease including metabolic or auto-immune liver diseases or viral hepatitis History or family history of medullary thyroid cancer(MTC), or multiple endocrine neoplasia type 2(MEN-2) Congestive heart failure(NYHA III~IV) Severe gastric-intestinal diseases Pregnancy and/or intention of becoming pregnant Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator; Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content. Herbal traditional Chinese medicine or other local herbal medicines may, at the Investigator's discretion, be continued throughout the trial at an unchanged dose

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianping Weng, Doctor

Organizational Affiliation

Third Affiliated Hospital, Sun Yat-Sen University

Official's Role

Study Director

Facility Information:

Facility Name

The Third Affiliated Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510630

Country

China

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects

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