Non-alcoholic Fatty Liver DiseasePhase 4LIGHT-ONNCT02147925
Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects
A Phase 4 study testing Liraglutide combined with metformin, Insulin glargine combined with metformin and Sitagliptin combined with metformin in people with Non-alcoholic Fatty Liver Disease, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Liraglutide combined with metformin, Insulin glargine combined with metformin and Sitagliptin combined with metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Apr 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
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
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.
Read the 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.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Liraglutide combined with metformin, Insulin glargine combined with metformin, Sitagliptin combined with metformin
- Keywords
- Non-alcoholic fatty liver disease, Glucagon-like peptide-1 receptor agonists, Diabetes mellitus, type 2
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide combined with metforminDrug
Also called Victoza®, Novo Nordisk
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
Insulin glargine combined with metforminDrug
Also called Lantus®, Sanofi
The initial dose will be 0.2 unit/kg/d
Sitagliptin combined with metforminDrug
Also called Januvia®, Merck & Co. Inc.
The dose throughout the study will be 100mg per day.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Active comparator | Liraglutide combined with metformin Receives: Drug: Liraglutide combined with metformin |
| Insulin glargine | Active comparator | Insulin glargine combined with metformin Receives: Drug: Insulin glargine combined with metformin |
| Sitagliptin | Active comparator | Sitagliptin combined with metformin Receives: Drug: Sitagliptin combined with metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26-week
Secondary outcomes (3)
Change of abdominal subcutaneous adipose tissue(SAT)
To compare the change of SAT in type 2 diabetic patients
Measured: 26 weeks
Change of visceral adipose tissue(VAT)
To compare the change of VAT in type 2 diabetic patients
Measured: 26 weeks
Change in hemoglobin A1c(HbA1c)
To compare the change of HbA1c in type 2 diabetic patients
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianping Weng, Sun Yat-sen University
- Investigators
- Jianping Weng, Doctor, Study director, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147925
- Sponsor's protocol ID
- IIS201404
- Acronym
- LIGHT-ON
- Status last verified
- Oct 2017
- First submitted
- 16 May 2014
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02147925
- Acronym / sponsor ID
- LIGHT-ON / IIS201404
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Non-alcoholic fatty liver disease, Glucagon-like peptide-1 receptor agonists, Diabetes mellitus, type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Active comparator | Drug: Liraglutide combined with metforminLiraglutide combined with metformin |
| Insulin glargine | Active comparator | Drug: Insulin glargine combined with metforminInsulin glargine combined with metformin |
| Sitagliptin | Active comparator | Drug: Sitagliptin combined with metforminSitagliptin combined with metformin |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide combined with metforminAlso: Victoza®, Novo NordiskLiraglutide, 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 | Drug | Liraglutide |
| Insulin glargine combined with metforminAlso: Lantus®, SanofiThe initial dose will be 0.2 unit/kg/d | Drug | Insulin glargine |
| Sitagliptin combined with metforminAlso: Januvia®, Merck & Co. Inc.The dose throughout the study will be 100mg per day. | Drug | Sitagliptin |
Primary outcome
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.
3 secondary outcomes
Change of abdominal subcutaneous adipose tissue(SAT)
Time frame: 26 weeks
Change of visceral adipose tissue(VAT)
Time frame: 26 weeks
Change in hemoglobin A1c(HbA1c)
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianping Weng, Doctor study director
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide combined with metformin, Insulin glargine combined with metformin and Sitagliptin combined with metformin in people with Non-alcoholic Fatty Liver Disease, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahepatic lipids (IHL) (time frame: 26-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.