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Clinical Trial Details

Trial ID: L1807
Source ID: NCT02303730
Associated Drug: Exenatide
Title: Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Non-alcoholic Fatty Liver Disease
Interventions: DRUG: Exenatide|DRUG: insulin glargine
Outcome Measures: Primary: Change in liver fat content(%) measured by MRS, Change in liver fat content(%) measured by MRS, baseline and 24 weeks | Secondary: Change in intra-abdominal visceral fat content (cm2), abdominal subcutaneous fat content (cm2), and ratio between intra-abdominal visceral fat and subcutaneous fat area by MRI, Change in intra-abdominal visceral fat content (cm2), abdominal subcutaneous fat content (cm2), and ratio between intra-abdominal visceral fat and subcutaneous fat area by MRI, baseline and 24 weeks|Change in glucose metabolism (fasting blood glucose, postprandial plasma glucose, HbA1c), Change in glucose metabolism (fasting blood glucose, postprandial plasma glucose, HbA1c), baseline and 24 weeks|Change in blood lipid profile (total cholesterol, triglyceride, HDL, LDL), Change in blood lipid profile (total cholesterol, triglyceride, HDL, LDL), baseline and 24 weeks|Change in body weight,waist circumference and hip circumference, Change in body weight,waist circumference and hip circumference, baseline and 24 weeks | Other: Change in cardiac function measured by echocardiography, Change in cardiac function measured by echocardiography, baseline and 24 weeks|Change in β-cell function (fasting C-peptide, 2-hour postprandial C-peptide), Change in β-cell function (fasting C-peptide, 2-hour postprandial C-peptide), baseline and 24 weeks|Change in liver enzymes and laboratory parameters (hematology, biochemical tests), Change in liver enzymes and laboratory parameters (hematology, biochemical tests), baseline and 24 weeks|Incidence of hypoglycaemia events, Incidence of hypoglycaemia events, up to 24 weeks|Incidence of adverse events(AEs)and Severe adverse events(SAEs), Incidence of adverse events(AEs)and Severe adverse events(SAEs), up to 24 weeks
Sponsor/Collaborators: Sponsor: Fudan University | Collaborators: Huadong Hospital|Shanghai Minhang Central Hospital|Shanghai 6th People's Hospital|Shanghai Changzheng Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 76
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-03
Completion Date: 2017-11
Results First Posted:
Last Update Posted: 2019-08-28
Locations: Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, 200032, China|Department of Endocrinology and Metabolism, Shanghai Minhang Central Hospital, Shanghai, Shanghai, China|Department of Endocrinology and Metabolism,Huadong Hospital, Shanghai, Shanghai, China|Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital, Shanghai, Shanghai, China|Department of Endocrinology and Metabolism,Shanghai Changzheng Hospital, Shanghai, Shanghai, China
URL: https://clinicaltrials.gov/show/NCT02303730