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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Active Comparator | Liraglutide combined with metformin |
|
| Insulin glargine | Active Comparator | Insulin glargine combined with metformin |
|
| Sitagliptin | Active Comparator | Sitagliptin combined with metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide combined with metformin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 26-week |
| Measure | Description | Time Frame |
|---|---|---|
| Change of abdominal subcutaneous adipose tissue(SAT) | To compare the change of SAT in type 2 diabetic patients | 26 weeks |
| Change of visceral adipose tissue(VAT) | To compare the change of VAT in type 2 diabetic patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianping Weng, Doctor | Third Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069450 | Liraglutide |
| D000069036 | Insulin Glargine |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D052216 |
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|
| Insulin glargine combined with metformin | Drug | The initial dose will be 0.2 unit/kg/d |
|
|
| Sitagliptin combined with metformin | Drug | The dose throughout the study will be 100mg per day. |
|
|
| 26 weeks |
| Change in hemoglobin A1c(HbA1c) | To compare the change of HbA1c in type 2 diabetic patients | 26 weeks |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |