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

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ClinicalTrials.gov Identifier: NCT02147925
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jianping Weng, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Drug: Liraglutide combined with metformin Drug: Insulin glargine combined with metformin Drug: Sitagliptin combined with metformin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017


Arm Intervention/treatment
Active Comparator: Liraglutide
Liraglutide combined with metformin
Drug: Liraglutide combined with metformin
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
Other Name: Victoza®, Novo Nordisk

Active Comparator: Insulin glargine
Insulin glargine combined with metformin
Drug: Insulin glargine combined with metformin
The initial dose will be 0.2 unit/kg/d
Other Name: Lantus®, Sanofi

Active Comparator: Sitagliptin
Sitagliptin combined with metformin
Drug: Sitagliptin combined with metformin
The dose throughout the study will be 100mg per day.
Other Name: Januvia®, Merck & Co. Inc.




Primary Outcome Measures :
  1. Intrahepatic lipids (IHL) [ Time Frame: 26-week ]
    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 :
  1. Change of abdominal subcutaneous adipose tissue(SAT) [ Time Frame: 26 weeks ]
    To compare the change of SAT in type 2 diabetic patients

  2. Change of visceral adipose tissue(VAT) [ Time Frame: 26 weeks ]
    To compare the change of VAT in type 2 diabetic patients

  3. Change in hemoglobin A1c(HbA1c) [ Time Frame: 26 weeks ]
    To compare the change of HbA1c in type 2 diabetic patients



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02147925


Locations
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China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: Jianping Weng, Doctor Third Affiliated Hospital, Sun Yat-Sen University
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Responsible Party: Jianping Weng, professor, vice president, the third affiliated hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02147925    
Other Study ID Numbers: IIS201404
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: October 2017
Keywords provided by Jianping Weng, Sun Yat-sen University:
Non-alcoholic fatty liver disease
Glucagon-like peptide-1 receptor agonists
Diabetes mellitus, type 2
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Metformin
Insulin Glargine
Sitagliptin Phosphate
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action