at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008, China
NCT Number: NCT03068065
This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide, liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.
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Notify Me17 year–80 year
All sexes
Interventional
Phase 4
Nanjing, Jiangsu, 210008, China
Following enrollment, eligible participants were randomized (1:1:1) using computer-generated random numbers to the metformin (Glucophage, Bristol-Myers Squibb), liraglutide (Victoza, Novo Nordisk), or gliclazide (Diamicron, Servier) groups. All patients were informed about a proper diet and exercise. For the metformin group (n = 31), the dosage was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study. For the gliclazide group (n = 31), the initial dosage was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of <7.0 mmol/L. For the liraglutide group (n = 31), the dosage was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study.At the end of the study, data will be collected and analyzed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the dosage of liraglutide was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study
Other names: Victoza,Novo Nordisk
the dosage of metformin was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study
Other names: Glucophage,Bristol-Myers Squibb
the initial dosage of gliclazide was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of <7.0 mmol/L
Other names: Diamicron MR,Servier
Time frame: -7±3days; 168±3days
intrahepatic fat change from baseline by quantitative ultrasound
Time frame: -7±3days; 28±3days; 84±3days; 168±3days
serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST)
Time frame: -7±3days; 28±3days; 84±3days; 168±3days
total cholesterol (CH), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL)
Time frame: -7±3days; 168±3days
plasma glucose was measured at 0, 30, 60, and 120 min after ingestion of the meal
Time frame: -7±3days; 168±3days
plasma insulin was measured at 0, 30, 60, and 120 min after ingestion of the meal
Time frame: 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days
fasting blood glucose (FBG), postprandial blood glucose (PBG)
Time frame: -7±3days; 84±3days; 168±3days
glycosylated hemoglobin A 1c (HbA1c) was measured by high-performance liquid chromatography
Time frame: -7±3days; 168±3days
fat mass and lean tissue were measured by dual-energy X-ray absorptiometry
Time frame: 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days
body weight
Time frame: 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days
waist circumference
Time frame: -7±3days; 0±3days; 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3day;168±3days
adverse events caused by the drugs
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Comparison of Efficacy of Liraglutide, Metformin and Gliclazide MR on Hepatic Lipid Content in Patients With Type 2 Diabetes (T2DM) and Non-alcoholic Fatty Liver (NAFLD)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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