Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Exenatide BID Compared With Insulin Glargine to Change Liver Fat Content in Non-alcoholic Fatty-liver Disease Patients With Type 2 Diabetes
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.
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