Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Exenatide; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): 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%.
Other intervention name(s): Byetta; Lantus
Intervention MeSH terms: Insulin Glargine; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Non-alcoholic Fatty Liver Disease