Table 3.
Summary of secondary endpoints
| Variable | Adjusted mean (SE) | Adjusted mean difference (95% Cl) | P-value | |
|---|---|---|---|---|
| Dapagliflozin group (n = 168) | Sitagliptin group (n = 163) | |||
| ΔBody weight (kg) | − 2.8 (0.3) | − 0.5 (0.3) | − 2.3 (− 2.9, − 1.7) | < 0.001 |
| ΔBMI (kg/m2) | − 1.0 (0.1) | − 0.2 (0.1) | − 0.9 (− 1.1, − 0.6) | < 0.001 |
| ΔSystolic blood pressure (mmHg) | − 3.8 (1.5) | − 1.9 (1.5) | − 1.9 (− 5.1, 1.4) | 0.26 |
| ΔDiastolic blood pressure (mmHg) | − 2.0 (1.0) | − 1.0 (1.1) | − 1.0 (− 3.3, 1.3) | 0.39 |
| ΔFasting plasma glucose (mg/dL) | − 23.0 (2.6) | − 15.1 (2.6) | − 7.9 (− 13.6, − 2.2) | 0.006 |
| ΔFasting plasma insulin (μU/mL)a | − 1.3 (0.9) | 1.0 (0.9) | − 2.3 (− 4.1, − 0.5) | NA |
| ΔFasting plasma insulin [ln(μU/mL)]a | − 0.17 (0.06) | 0.17 (0.06) | − 0.34 (− 0.46, − 0.21) | < 0.001 |
| ΔHbA1c (NGSP%) | − 0.9 (0.1) | − 0.9 (0.1) | 0.0 (− 0.1, 0.2) | 0.85 |
| ΔHbA1c (mmol/mol) | − 9.5 (0.8) | − 9.6 (0.8) | 0.2 (− 1.4, 1.7) | 0.85 |
| ΔHDL cholesterol (mg/dL)a | 4.5 (0.8) | 0.2 (0.8) | 4.3 (2.6, 6.0) | NA |
| ΔHDL cholesterol [ln(mg/dL)]a | 0.07 (0.01) | 0.00 (0.01) | 0.07 (0.04, 0.10) | < 0.001 |
| ΔLDL cholesterol (mg/dL)a | − 0.4 (3.0) | − 3.8 (2.9) | 3.4 (− 3.4, 10.1) | NA |
| ΔLDL cholesterol [ln(mg/dL)]a | 0.00 (0.02) | − 0.04 (0.02) | 0.04 (− 0.01, 0.09) | 0.15 |
| ΔTriglycerides (mg/dL)a | − 17.6 (11.0) | − 12.2 (11.1) | − 5.5 (− 30.0, 19.1) | NA |
| ΔTriglycerides [ln(mg/dL)]a | − 0.11 (0.04) | − 0.05 (0.04) | − 0.06 (− 0.15, 0.04) | 0.25 |
| ΔAST (IU/L)a | − 3.6 (0.9) | 1.4 (0.9) | − 5.0 (− 6.9, − 3.1) | NA |
| ΔAST [ln(IU/L)]a | − 0.12 (0.03) | 0.03 (0.03) | − 0.15 (− 0.21, − 0.09) | <0.001 |
| ΔALT (IU/L)a | − 7.4 (1.3) | 0.5 (1.3) | − 7.9 (− 10.8, − 5.0) | NA |
| ΔALT [ln(IU/L)]a | − 0.23 (0.03) | − 0.02 (0.03) | − 0.21 (− 0.28, − 0.13) | < 0.001 |
| ΔHematocrit (%) | 2.3 (0.2) | − 0.4 (0.2) | 2.7 (2.2, 3.2) | < 0.001 |
| ΔUA (mg/dL) | − 0.5 (0.1) | 0.3 (0.1) | − 0.7 (− 0.9, − 0.5) | < 0.001 |
| ΔBUN (mg/dL)a | 1.2 (0.4) | 0.0 (0.4) | 1.1 (0.3, 2.0) | NA |
| ΔBUN [ln(mg/dL)]a | 0.10 (0.02) | 0.02 (0.02) | 0.08 (0.03, 0.13) | 0.001 |
| ΔCreatinine (mg/dL)a | 0.0 (0.0) | 0.0 (0.0) | 0.0 (0.0, 0.0) | NA |
| ΔCreatinine [ln(mg/dL)]a | 0.02 (0.01) | 0.04 (0.01) | − 0.02 (− 0.05, 0.00) | 0.025 |
| ΔeGFR (mL/min/1.73 m2) | − 1.4 (0.8) | − 3.5 (0.8) | 2.0 (0.2, 3.9) | 0.032 |
| ΔGlucose > 10.0 mmol/L (180 mg/dL) within 24 h | ||||
| Duration (h) | − 4.4 (0.4) | − 3.9 (0.4) | − 0.5 (− 1.5, 0.4) | 0.29 |
| ΔSD of glucose (mg/dL) | − 6.0 (0.9) | − 8.6 (0.9) | 2.6 (0.7, 4.5) | 0.006 |
| ΔCV glucose (%) | 1.0 (0.4) | − 1.4 (0.4) | 2.4 (1.5, 3.2) | < 0.001 |
| ΔMAGE (mg/dL) | − 14.9 (2.2) | − 22.9 (2.2) | 7.9 (3.1, 12.8) | 0.002 |
| ΔCONGA for 2 h (mg/dL) | − 5.5 (0.9) | − 9.5 (0.9) | 3.9 (1.9, 6.0) | < 0.001 |
| ΔCONGA for 6 h (mg/dL) | − 9.0 (1.3) | − 13.2 (1.3) | 4.2 (1.2, 7.1) | 0.006 |
Data are presented as adjusted mean (SE) and adjusted mean difference (95% CI). P-values for between-group comparisons were obtained using analysis of covariance
SE standard error, CI confidence interval, Δ amount of change from baseline to 24 weeks, BMI body mass index, HbA1c glycated hemoglobin, NGSP National Glycohemoglobin Standardization Program, HDL high-density lipoprotein, LDL low-density lipoprotein, AST aspartate aminotransferase, ALT alanine aminotransferase, UA uric acid, BUN blood urea nitrogen, eGFR estimated glomerular filtration rate, SD standard deviation, CV coefficient of variation, MAGE mean amplitude of glycemic excursion, CONGA continuous overall net glycemic action, NA not applicable
aVariables with skewed distributions were performed log-transformed and were analyzed using log-transformed data