Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis \& glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Ertugliflozin 5/15mg once daily in addition to standard of care
North west general hospital
Peshawar, KPK, Pakistan
RECRUITINGRadiologic liver parameters
Number of participants reported change in liver fat content from baseline, as quantified by fibroscan
Time frame: up to 24 weeks
HbA1c% levels compare with baseline in 6 months
Efficacy
Time frame: up to 24 weeks
Change in body weight compare with baseline in 6 months
Body Weight
Time frame: up to 24 weeks
Change in waist circumference compare with baseline in 6 months
Waist Circumference
Time frame: up to 24 weeks
Fibrosis 4 score levels compare with baseline in 6 months
Fibrosis Scoring \< 1.45 indicates Fibrosis Stage 0-2, 1.45 to 3.25 is deemed indeterminate fibrosis stage, \> 3.25 indicates Fibrosis stage 3-4
Time frame: up to 24 weeks
Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months
Non-Alchoholic Fatty Liver Disease Fibrosis Scoring, \< -1.455 indicates Fibrosis Stage 0-2, -1.455 to 0.676 is considered indeterminate fibrosis stage, \> 0.676 indicates Fibrosis Stage 3-4
Time frame: up to 24 weeks
Frequency of adverse events in 6 months
Safety
Time frame: up to 24 weeks
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