Variable | Be | Bi | BB | Placebo | P value | Pchange value | ||||
---|---|---|---|---|---|---|---|---|---|---|
16 weeks | Change | 16 weeks | Change | 16 weeks | Change | 16 weeks | Change | |||
Primary efficacy endpoint | ||||||||||
 FBG, mmol/L | 6.20 ± 0.80 | − 0.37 (− 0.69, − 0.06)a | 6.43 ± 0.93 | − 0.06 (− 0.28, 0.16)b | 6.16 ± 0.91 | − 0.42 (− 0.73, − 0.12)a | 6.67 ± 1.34 | 0.13 (− 0.09, 0.35) | 0.067 | 0.004 |
Secondary efficacy endpoint | ||||||||||
 2-hr PPG, mmol/L | 9.84 ± 2.93 | − 1.16 (− 2.09, − 0.23)a | 11.33 ± 3.50 | 0.01 (− 0.64, 0.65)b | 9.79 ± 2.49 | − 1.37 (− 2.27, − 0.48)a | 11.49 ± 3.66 | 0.21 (− 0.44, 0.87) | 0.004 | 0.004 |
 HbA1c, % | 6.08 ± 0.52 | − 0.05 (− 0.19, 0.08) | 6.15 ± 0.61 | 0.02 (− 0.07, 0.12)b | 5.90 ± 0.52 | − 0.22 (− 0.36, − 0.09)a | 6.14 ± 0.66 | 0.00 (− 0.10, 0.10) | 0.111 | 0.016 |
 TG, mmol/L | 1.77 (1.19–2.47) | − 0.14 (− 0.46, 0.19) | 1.81 (1.32–2.54) | 0.04 (− 0.18, 0.27) | 1.41 (0.99–2.05) | − 0.18 (− 0.50, 0.15) | 1.73 (1.12–2.13) | − 0.06 (− 0.29, 0.17) | 0.514 | 0.605 |
 TC, mmol/L | 4.64 ± 1.15 | − 0.25 (− 0.50, 0.00)a | 4.81 ± 1.03 | 0.02 (− 0.15, 0.19)b | 4.14 ± 0.94 | − 0.38 (− 0.63, − 0.13)a | 4.79 ± 0.94 | 0.06 (− 0.12, 0.24) | 0.002 | 0.004 |
 HDL-C, mmol/L | 1.14 ± 0.26 | 0.00 (− 0.06, 0.07)a | 1.21 ± 0.33 | 0.04 (0.00, 0.09)a | 1.15 ± 0.22 | 0.03 (− 0.03, 0.10)a | 1.25 ± 0.31 | 0.11 (0.07, 0.16) | 0.161 | 0.012 |
 LDL-C, mmol/L | 2.76 ± 0.81 | − 0.15 (− 0.34, 0.05) | 2.90 ± 0.81 | − 0.00 (0.14, 0.14)b | 2.41 ± 0.76 | − 0.32 (− 0.52, − 0.12)a | 2.85 ± 0.85 | 0.01 (− 0.13, 0.15) | 0.011 | 0.018 |
 BMI, kg/m2 | 24.47 ± 2.78 | − 0.42 (− 0.70, − 0.14) | 24.90 ± 2.19 | − 0.37 (− 0.56, − 0.17) | 24.96 ± 2.81 | − 0.30 (− 0.57, − 0.03) | 24.88 ± 2.61 | − 0.19 (− 0.39, 0.01) | 0.797 | 0.409 |
 BW, kg | 66.69 ± 10.12 | − 1.29 (− 2.09, − 0.48) | 68.39 ± 8.56 | − 1.03 (− 1.59, − 0.46) | 68.67 ± 10.74 | − 0.93 (− 1.71, − 0.15) | 69.31 ± 10.64 | − 0.42 (− 0.99, 0.16) | 0.576 | 0.204 |
 Waist circumference, cm | 86.64 ± 8.75 | − 2.19 (− 3.41, − 0.96) | 89.78 ± 7.40 | − 1.26 (− 2.11, − 0.41) | 90.50 ± 8.32 | − 0.81 (− 2.00, 0.37) | 90.22 ± 8.22 | − 0.92 (− 1.79, − 0.05) | 0.087 | 0.284 |
 HOMA-IR | 2.56 (1.87–3.36) | 0.04 (− 0.62, 0.71) | 2.70 (1.89–4.25) | − 0.10 (− 0.58, 0.38) | 2.28 (1.78–3.02) | − 0.63 (− 1.29, 0.03) | 2.72 (1.58–3.86) | − 0.12 (− 0.61, 0.36) | 0.815 | 0.446 |
 HOMA-β | 68.8 (51.98–111.85) | 6.52 (− 4.59, 17.62) | 67.51 (49.80–101.45) | 0.49 (− 7.56, 8.54) | 69.03 (46.59–111.06) | 4.42 (− 6.54, 15.38) | 61.51 (43.24–95.42) | − 5.78 (− 13.87, 2.31) | 0.313 | 0.215 |
 Fasting GLP-1, pmol/L | 2.26 (1.08–4.63) | 1.36 (− 0.64, 3.36) | 1.93 (1.27–3.89) | − 1.67 (− 3.10, − 0.25) | 2.40 (1.34–3.68) | − 1.71 (− 3.66, 0.23) | 2.23 (1.20–5.16) | − 0.87 (− 2.32, 0.57) | 0.901 | 0.055 |
 30 min post-GLP-1, pmol/L | 3.17 (1.77–7.81) | − 0.70 (− 4.11, 2.71) | 3.03 (1.98–6.11) | − 1.54 (− 3.96, 0.88) | 3.18 (2.31–6.07) | − 0.72 (− 4.04, 2.59) | 2.33 (1.54–5.73) | 0.77 (− 1.67, 3.21) | 0.572 | 0.529 |
 2-hr post-GLP-1, pmol/L | 3.17 (2.26–5.22) | 0.94 (− 0.25, 2.12) | 2.31 (1.93–4.10) | − 0.89 (− 1.73, − 0.05) | 2.68 (1.83–3.91) | − 0.70 (− 1.86, 0.45) | 2.78 (1.80–4.08) | − 0.40 (− 1.25, 0.44) | 0.153 | 0.062 |
 AUC GLP-1 | 6.43 (3.81–11.75) | − 0.25 (− 4.34, 3.83) | 6.02 (4.05–9.67) | − 2.83 (− 5.75, 0.09) | 5.70 (4.22–7.62) | − 2.31 (− 6.24, 1.62) | 5.48 (3.68–11.54) | 0.02 (–2.93, 2.97) | 0.470 | 0.427 |