Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects
NCT ID: NCT02147925
Last Updated: 2018-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
75 participants
INTERVENTIONAL
2014-08-31
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sitagliptin
Sitagliptin combined with metformin
Sitagliptin combined with metformin
The dose throughout the study will be 100mg per day.
Liraglutide
Liraglutide combined with metformin
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
Insulin glargine
Insulin glargine combined with metformin
Insulin glargine combined with metformin
The initial dose will be 0.2 unit/kg/d
Interventions
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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
Insulin glargine combined with metformin
The initial dose will be 0.2 unit/kg/d
Sitagliptin combined with metformin
The dose throughout the study will be 100mg per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Jianping Weng
professor, vice president, the third affiliated hospital of Sun Yat-sen University
Principal Investigators
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Jianping Weng, Doctor
Role: STUDY_DIRECTOR
Third Affiliated Hospital, Sun Yat-Sen University
Locations
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The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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IIS201404
Identifier Type: -
Identifier Source: org_study_id
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