Proportion of patients achieving plasma K-18 change ≥50 and ≥100 U/L
| 26 Weeks | 52 Weeks | 78 Weeks | |||||||
| GL | BIL | P Value* | GL | BIL | P Value* | GL | BIL | P Value* | |
| Type 1 diabetes | |||||||||
| N | 60 | 114 | 58 | 103 | 38 | 74 | |||
| K-18 change ≥50 U/L | 6 (10.0) | 28 (24.6) | 0.031 | 7 (12.1) | 28 (27.2) | 0.024 | 5 (13.2) | 12 (16.2) | 0.671 |
| K-18 change ≥100 U/L | 1 (1.7) | 14 (12.3) | 0.017 | 2 (3.4) | 13 (12.6) | 0.062 | 3 (7.9) | 9 (12.2) | 0.491 |
| K-18 change ≥100 U/L and K-18 ≥600 U/L | 0 (0.0) | 0 (0.0) | – | 0 (0.0) | 2 (1.9) | 0.318 | 1 (2.6) | 1 (1.4) | 0.630 |
| Type 2 diabetes, insulin-naïve | |||||||||
| N | 51 | 106 | 48 | 99 | 18 | 38 | |||
| K-18 change ≥50 U/L | 6 (11.8) | 27 (25.5) | 0.060 | 7 (14.6) | 30 (30.3) | 0.044 | 2 (11.1) | 17 (44.7) | 0.016 |
| K-18 change ≥100 U/L | 3 (5.9) | 20 (18.9) | 0.032 | 1 (2.1) | 20 (20.2) | 0.002 | 1 (5.6) | 11 (28.9) | 0.079 |
| K-18 change ≥100 U/L and K-18 ≥600 U/L | 1 (2.0) | 5 (4.7) | 0.665 | 0 (0.0) | 5 (5.1) | 0.173 | 1 (5.6) | 2 (5.3) | >0.999 |
| Type 2 diabetes, previously treated with insulin | |||||||||
| N | 47 | 103 | 45 | 97 | – | – | – | ||
| K-18 change ≥50 U/L | 4 (8.5) | 51 (49.5) | <0.001 | 12 (26.7) | 48 (49.5) | 0.011 | – | – | – |
| K-18 change ≥100 U/L | 1 (2.1) | 36 (35.0) | <0.001 | 7 (15.6) | 35 (36.1) | 0.017 | – | – | – |
| K-18 change ≥100 U/L and K-18 ≥600 U/L | 0 (0.0) | 11 (10.7) | 0.018 | 1 (2.2) | 11 (11.3) | 0.104 | – | – | – |
Data are presented as n (%).
*P values are for between-treatment comparisons at each time-point.
N, number of patients randomized; BIL, basal insulin peglispro; GL, insulin glargine; K-18, cytokeratin-18; T1D, type 1 diabetes; T2D, type 2 diabetes.