Baseline | 7 months | 10 months | |||||||
---|---|---|---|---|---|---|---|---|---|
Empagliflozin | Placebo | Empagliflozin | Placebo | PI(0−7) | Empagliflozin | Placebo | PI(7−10) | PI overall | |
Indexes of β-cell function | |||||||||
Insulinogenic index | 84.8 (58.8, 100.0) | 72.4 (48.0, 111.7) | 64.2 (57.1, 98.3) | 57.9 (48.8, 75.2) | 0.47 | 107.3 (78.3, 129.4) | 65.1 (47.8, 88.3) | 0.33 | 0.69 |
First phase Stumvoll | 800.2 (600.0) | 921.8 (596.0) | 897.1 (460.9) | 795.1 (617.3) | 0.55 | 1066.0 (525.5) | 844.0 (503.9) | 0.55 | 0.55 |
s phase Stumvoll | 242.0 (130.7) | 265.5 (137.0) | 253.5 (104.0) | 237.4 (140.9) | 0.47 | 297.3 (121.9) | 248.9 (117.8) | 0.47 | 0.47 |
C-peptide index | 2.82 (2.40, 3.39) | 2.85 (2.03, 3.44) | 2.58 (2.09, 3.69) | 2.56 (1.90, 3.64) | 0.33 | 2.69 (2.10, 3.79) | 2.98 (2.02, 3.44) | 0.33 | 0.40 |
totAUCIGI | 45.5 (23.3) | 51.1 (24.6) | 39.2 (15.2) | 42.3 (19.8) | 0.18 | 51.9 (19.7) | 43.3 (21.11) | 0.67 | 0.18 |
HOMA2-β (mU/l, mmol/l) | 72.6 (61.9, 94.2) | 73.5 (58.6, 101.8) | 70.5 (50.5, 117.0) | 76.5 (47.5, 123.5) | 0.55 | 83.5 (60.0, 92.4) | 88.4 (54.2, 104.2) | 0.55 | 0.55 |
Proinsulin/Insulin | 0.18 (0.07) | 0.17 (0.06) | 0.17 (0.07) | 0.16 (0.06) | 0.71 | - | - | - | 0.71 |
Indexes of insulin resistance | |||||||||
HOMA-IR (traditional) | 4.0 (1.8) | 4.3 (3.0) | 2.6 (1.3) | 4.0 (2.5) | 0.07 | 4.0 (2.8) | 4.5 (3.2) | 0.011 | 0.19 |
HOMA2-IR | 1.5 (1.1, 1.8) | 1.5 (1.0, 2.1) | 1.4 (0.6, 1.7) | 1.4 (0.9, 2.3) | 0.28 | 1.5 (1.0, 1.8) | 1.6 (1.0, 2.1) | 0.03 | 0.20 |
VAI | 1.39 (1.09, 1.63) | 1.64 (1.16, 2.44) | 1.08 (0.82, 1.82) | 1.63 (1.15, 2.02) | 0.82 | 1.12 (0.77, 1.90) | 1.45 (1.30, 2.22) | 0.82 | 0.82 |
LAP | 37.2 (26.9, 51.4) | 46.8 (32.7, 62.7) | 36.1 (19.4, 48.0) | 42.1 (30.2, 54.0) | 0.95 | 33.84 (28.5, 50.4) | 44.1 (35.3, 59.3) | 0.95 | 0.95 |
Indexes of insulin sensitivity | |||||||||
QUICKI | 0.32 (0.3, 0.33) | 0.32 (0.30, 0.34) | 0.33 (0.32, 0.36) | 0.32 (0.30, 0.33) | 0.0001 | 0.32 (0.31, 0.34) | 0.31 (0.30, 0.33) | 0.004 | 0.01 |
HOMA2-S | 66.8 (54.6, 88.3) | 68.5 (47.7, 101.3) | 71.1 (59.0, 171.3) | 70.5 (44.3, 108.5) | 0.001 | 68.9 (56.9, 96.8) | 64.6 (47.1, 99.0) | 0.014 | 0.03 |
Stumvoll MCR120 | 9.26 (8.43, 9.67) | 9.14 (8.27, 9.61) | 9.68 (8.46, 10.04) | 9.06 (8.22, 9.55) | 0.0001 | 9.22 (8.46, 10.04) | 9.06 (8.22, 9–55) | 0.004 | 0.003 |
Matsuda Index | 2.22 (1.48–3.15) | 2.53 (1.59–3.02) | 2.78 (2.29–4.36) | 3.13 (2.13–3.59) | 0.14 | 2.32 (1.82–2.51) | 3.04 (1.02–4.00) | 0.34 | 0.05 |