The purpose of this study is to evaluate whether exenatide is superior to insulin glargine (after 24 weeks) in reducing liver fat content (by MRS) in patients with newly diagnosed type 2 diabetes mellitus and concomitant non-alcoholic fatty-liver disease(NAFLD).
This is a randomized, open-label, parallel-group, active controlled, multi-center clinical trial to investigate whether exenatide is superior to insulin glargine in reducing liver fat content in patients with newly diagnosed type 2 diabetes mellitus and concomitant NAFLD.Patients with type 2 diabetes and concomitant NAFLD from 18-70 years of age, with inadequate glycaemic control defined as 7% ≤ HbA1c ≤ 10% and BMI≥24kg/ m2 at the time of screening. Patients should be on diet and exercise but drug treatment naive, no use of any glucagon-like peptide-1(GLP-1) analogues or insulin within 3 months before enrolment.Patients will have an screening period 2 weeks, and a 24-week open label treatment period. All demographic data variables collected by descriptive analysis tests are used. Qualitative variables use absolute frequency and percentage, and numeric variables use average, mean, median, standard deviation, maximum, minimum, quartiles, etc. Unless specifically stated, statistical significance will be defined as P\<0.05 in the whole analysis procedure.For the primary endpoint of this study, superiority test will be applied to the quantitative data of these two groups. For secondary and exploratory efficacy variables, difference test will be used to analyse repeated measurement data from two groups. For essential Safety parameters, difference test will be used to analyse the differences between two groups.The analysis of all primary and secondary endpoints of efficacy and safety must be based on the Full Analysis Set (FAS). As supporting evidence, the analysis of primary endpoint variables must also comply with the Pre-protocol (PPS) Analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
The starting dose of exenatide is 5 ug bid, subcutaneously, for 4 weeks, followed by 10 ug bid, subcutaneously, for 20 weeks. If hypoglycaemia (blood glucose\<2.9 mmol/l or \< 3.9 mmol/l at least 2 times) or serious intolerance occurs, the dose will be adjusted to 5 ug bid, subcutaneously.
The starting dose of insulin glargine will depend upon the HbA1c level at screening(HbA1c \<8% use 0.1 -0.2 U/kg per day;HbA1c \>8% use 0.2 -0.3 U/kg per day). Dose adjustment protocol for insulin glargine (at least 3 determinations of fasting blood glucose per week): fasting blood glucose(FBG) \> 180 mg/dL(10 mmol/l): add 4 U; FBG 140-180 mg/dL(7.8-10 mmol/l): add 2 U; FBG 126-139 mg/dL(7.0-7.8 mmol/l): add 1 U. If hypoglycemia, reduce insulin glargine by: blood glucose \<70mg/dl（3.9mmol/l）: 10%-20%; blood glucose \<40mg/dl（2.2mmol/l）: 20%-40%.
Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Department of Endocrinology and Metabolism, Shanghai Minhang Central Hospital
Shanghai, Shanghai Municipality, China
Department of Endocrinology and Metabolism,Huadong Hospital
Shanghai, Shanghai Municipality, China
Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital
Change in liver fat content（%） measured by MRS
Change in liver fat content（%） measured by MRS
Time frame: baseline and 24 weeks
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
Time frame: 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)
Time frame: baseline and 24 weeks
Change in blood lipid profile (total cholesterol, triglyceride, HDL, LDL)
Change in blood lipid profile (total cholesterol, triglyceride, HDL, LDL)
Time frame: baseline and 24 weeks
Change in body weight,waist circumference and hip circumference
Change in body weight,waist circumference and hip circumference
Time frame: baseline and 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Shanghai, Shanghai Municipality, China
Department of Endocrinology and Metabolism,Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China