Fig. 1Flow diagram for selection of study participants. T2DM, type 2 diabetes mellitus; NAFLD, non-alcoholic fatty liver disease; OAD, oral antidiabetic drugs; DPP4i, dipeptidyl peptidase-4 inhibitor.
Fig. 2Comparison of alanine aminotransferase (ALT) reduction between two groups. ALT decreased significantly in both groups but decreased more in the dapagliflozin group than in the dipeptidyl peptidase-4 (DPP4) inhibitor group. The difference in the ALT reduction between the two groups was statistically significant (−21.1 U/L vs. −9.5 U/L, P=0.008).
Fig. 3The proportion of patients with alanine aminotransferase (ALT) normalization. The percentage of ALT normalization was significantly higher in the dapagliflozin group than in the dipeptidyl peptidase-4 (DPP4) inhibitor group (80.0% vs. 61.5%, P=0.041).
Table 1Demographic and Baseline Characteristics of Non-alcoholic Fatty Liver Disease Patients with T2DM
Characteristic |
Metformin+DPP4i (n=52) |
Metformin+dapagliflozin (n=50) |
P value |
Age, yr |
56.6±7.4 |
50.7±10.2 |
0.001 |
Sex |
|
|
0.441 |
Male |
34 (65.4) |
31 (62.0) |
Female |
18 (34.6) |
19 (38.0) |
Body weight, kg |
73.7±12.8 |
79.8±14.6 |
0.028 |
Height, cm |
166.4±7.9 |
166.8±9.4 |
0.804 |
BMI, kg/m2
|
26.47±3.35 |
28.56±3.92 |
0.005 |
Duration of T2DM, yr |
5.5±5.3 |
4.0±4.5 |
0.540 |
HbA1c, % |
7.4±1.5 |
8.3±1.7 |
0.005 |
FBS, mg/dL |
133.6±33.1 |
175.1±57.3 |
<0.001 |
HOMA-IR |
2.6±1.8 |
6.4±2.3 |
0.003 |
AST, U/L |
35.6±9.6 |
36.3±11.2 |
0.740 |
ALT, U/L |
49.6±10.4 |
51.9±14.7 |
0.362 |
Total cholesterol, mg/dL |
160.9±32.5 |
186.2±43.8 |
0.002 |
LDL-C, mg/dL |
93.3±27.4 |
102.3±40.7 |
0.205 |
HDL-C, mg/dL |
43.3±10.6 |
48.5±16.1 |
0.071 |
Triglycerides, mg/dL |
155.7±67.6 |
217.9±131.3 |
0.005 |
Hypertension |
32 (61.5) |
34 (68.0) |
0.040 |
Estimated GFRa, mL/min/1.73 m2
|
70.5±10.8 |
75.4±14.1 |
0.055 |
Table 2Changes in Clinical Parameters Compared between Baseline and after Treatment
Parameter |
Metformin+DPP4i (n=52) |
Metformin+dapagliflozin(n=50) |
P value |
Body weight, kg |
|
|
|
Baseline |
73.7±12.8 |
79.8±14.6 |
0.028 |
Post-treatment |
73.1±12.6 |
76.9±14.5 |
0.172 |
Change from baseline |
−0.4±2.7 |
−2.9±5.4 |
0.005 |
HbA1c, % |
|
|
|
Baseline |
7.4±1.5 |
8.3±1.7 |
0.005 |
Post-treatment |
7.2±1.1 |
7.7±1.4 |
0.036 |
Change from baseline |
−0.2±1.5 |
−0.6±1.2 |
0.170 |
FBS, mg/dL |
|
|
|
Baseline |
133.6±33.1 |
175.1±57.3 |
<0.001 |
Post-treatment |
137.0±36.6 |
148.5±43.8 |
0.150 |
Change from baseline |
3.35±37.6 |
−26.5±53.2 |
0.002 |
AST, U/L |
|
|
|
Baseline |
35.6±9.6 |
36.3±11.2 |
0.740 |
Post-treatment |
29.6±13.1 |
24.9±14.4 |
0.086 |
Change from baseline |
−6.0±13.8 |
−11.4±16.6 |
0.077 |
ALT, U/L |
|
|
|
Baseline |
49.6±10.4 |
51.9±14.7 |
0.362 |
Post-treatment |
40.1±22.7 |
30.8±15.6 |
0.018 |
Change from baseline |
−9.5±22.8 |
−21.1±20.1 |
0.008 |
Total cholesterol, mg/dL |
|
|
|
Baseline |
160.9±32.5 |
186.2±43.8 |
0.002 |
Post-treatment |
156.4±28.7 |
177.2±33.8 |
0.001 |
Change from baseline |
−4.5±34.9 |
−9.8±43.9 |
0.510 |
LDL-C, mg/dL |
|
|
|
Baseline |
93.3±27.4 |
102.3±40.7 |
0.205 |
Post-treatment |
84.6±28.0 |
90.8±28.8 |
0.286 |
Change from baseline |
−8.4±28.4 |
−12.0±40.1 |
0.620 |
HDL-C, mg/dL |
|
|
|
Baseline |
43.3±10.6 |
48.5±16.1 |
0.071 |
Post-treatment |
45.5±9.0 |
48.0±8.9 |
0.185 |
Change from baseline |
2.2±8.9 |
−0.4±14.0 |
0.280 |
Triglycerides, mg/dL |
|
|
|
Baseline |
155.7±67.6 |
217.9±131.3 |
0.005 |
Post-treatment |
164.0±82.4 |
214.7±123.4 |
0.023 |
Change from baseline |
9.0±81.1 |
−2.7±128.7 |
0.598 |
Table 3Odds Ratios for Alanine Aminotransferase Normalization in Type 2 Diabetic Patients with Non-alcoholic Fatty Liver Disease