At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Exenatide BID Compared With Insulin Glargine to Change Liver Fat Content in Non-alcoholic Fatty-liver Disease Patients With Type 2 Diabetes
In Brief
A Phase 4 clinical trial evaluating Exenatide and insulin glargine for Diabetes Mellitus, Type 2 and Non-alcoholic Fatty Liver Disease. Completed, enrolled 76 participants across 5 sites.
Detailed 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).
Study Details
Timeline
Interventions
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%.