iGlarLixi | iGlar | Lixisenatide | |||||||
NA n=136 | RoW n=332 | P value | NA n=155 | RoW n=311 | P value | NA n=80 | RoW n=153 | P value | |
HbA1c, mmol/mol | |||||||||
Baseline | 89.5 (7.5) | 87.8 (7.8) | 0.031 | 89.8 (7.8) | 87.6 (7.3) | 0.002 | 91.2 (8.5) | 87.7 (7.3) | 0.001 |
Change from baseline | –16.7 (9.9) | –16.7 (9.5) | 0.995 | –13.3 (9.3) | –13.6 (9.6) | 0.805 | –7.7 (9.7) | –9.2 (9.4) | 0.221 |
HbA1c, % | |||||||||
Baseline | 8.19 (0.69) | 8.03 (0.71) | 0.031 | 8.22 (0.71) | 8.01 (0.67) | 0.002 | 8.34 (0.78) | 8.02 (0.67) | 0.001 |
Change from baseline | −1.53 (0.91) | −1.53 (0.87) | 0.995 | −1.22 (0.85) | −1.24 (0.88) | 0.805 | −0.70 (0.89) | −0.84 (0.86) | 0.221 |
PPG,* mmol/L | n=115 | n=315 | n=132 | n=298 | n=62 | n=134 | |||
Baseline | 14.60 (3.71) | 15.41 (3.58) | 0.040 | 13.88 (3.27) | 14.93 (3.75) | 0.005 | 14.53 (3.09) | 14.81 (3.43) | 0.584 |
Change from baseline | –6.45 (4.40) | –5.90 (4.22) | 0.237 | –3.37 (3.43) | –3.22 (3.59) | 0.690 | –4.60 (3.94) | –4.79 (4.20) | 0.753 |
FPG, mmol/L | |||||||||
Baseline | 10.07 (2.39) | 9.79 (2.33) | 0.244 | 9.76 (2.41) | 9.75 (2.29) | 0.948 | 9.85 (2.24) | 9.76 (2.13) | 0.764 |
Change from baseline | –3.63 (2.59) | –3.37 (2.58) | 0.309 | –3.06 (2.86) | –3.18 (2.72) | 0.673 | –1.81 (2.95) | –1.22 (2.45) | 0.105 |
Weight† (kg) | |||||||||
Baseline | 91.8 (18.0) | 88.5 (16.8) | 0.055 | 89.8 (16.8) | 89.7 (16.2) | 0.944 | 89.5 (18.2) | 91.5 (15.2) | 0.378 |
Change from baseline | 0.3 (4.2) | –0.5 (3.4) | 0.034 | 1.8 (4.1) | 0.75 (4.1) | 0.008 | –1.48 (3.2) | –2.74 (3.4) | 0.006 |
Insulin dose (units) Week 30 | 40.6 (14.7) | 38.3 (15.2) | 0.128 | 40.6 (14.6) | 39.2 (15.4) | 0.342 | N/A | N/A | N/A |
Composite endpoint‡, n (%) | 35 (25.7) | 114 (34.3) | 0.060 | 17 (11.0) | 71 (22.8) | 0.001 | 11 (13.8) | 50 (32.7) | <0.001 |
iGlarLixi | iGlar | |||||
NA n=105 | RoW n=261 | P value | NA n=91 | RoW n=274 | P value | |
HbA1c, mmol/mol | ||||||
Baseline | 88.8 (7.8) | 88.0 (7.3) | 0.319 | 88.8 (8.0) | 88.1 (8.0) | 0.521 |
Change from baseline | –11.8 (11.1) | –12.0 (9.2) | 0.836 | –6.2 (9.2) | –6.4 (9.5) | 0.840 |
HbA1c, % | ||||||
Baseline | 8.12 (0.71) | 8.05 (0.67) | 0.319 | 8.12 (0.73) | 8.06 (0.73) | 0.521 |
Change from baseline | −1.08 (1.01) | −1.10 (0.84) | 0.836 | −0.57 (0.84) | −0.59 (0.87) | 0.840 |
PPG,* mmol/L | n=86 | n=246 | n=81 | n=259 | ||
Baseline | 13.78 (3.29) | 15.23 (3.92) | 0.002 | 13.59 (3.97) | 15.40 (3.47) | <0.001 |
Change from baseline | –4.50 (4.51) | –5.10 (4.48) | 0.286 | –1.09 (5.18) | –1.70 (3.85) | 0.254 |
FPG, mmol/L | ||||||
Baseline | 6.91 (2.04) | 7.49 (1.88) | 0.009 | 6.90 (2.00) | 7.46 (2.08) | 0.024 |
Change from baseline | –0.38 (2.92) | –0.49 (2.59) | 0.715 | –0.09 (3.05) | –0.77 (2.56) | 0.036 |
Weight, kg | ||||||
Baseline | 87.6 (14.0) | 87.9 (14.6) | 0.832 | 89.7 (16.1) | 86.2 (14.2) | 0.053 |
Change from baseline | –0.4 (3.8) | –0.6 (3.0) | 0.710 | 1.2 (2.9) | 0.7 (2.7) | 0.192 |
Insulin dose, units | ||||||
Baseline | 36.3 (9.1) | 34.43 (9.2) | 0.086 | 37.62 (8.0) | 34.43 (8.7) | 0.002 |
Change from baseline | 8.7 (11.5) | 11.49 (10.2) | 0.025 | 8.77 (9.5) | 12.37 (9.9) | 0.003 |
Composite endpoint‡, n (%) | 14 (13.3) | 59 (22.6) | 0.028 | 9 (9.9) | 24 (8.8) | 0.751 |
Data are mean (SD).
*Measured 2 hours after standard liquid meal in a subset of patients.
†iGlarLixi arm: NA, n = 135; RoW, n = 332.
‡Composite endpoint of HbA1c <42 mmol/mol (<7.0%), no weight gain or symptomatic hypoglycemia (blood glucose ≤3.9 mmol/L (≤70 mg/dL)).
FPG, fasting plasma glucose; iGlar, insulin glargine; iGlarLixi, insulin glargine/lixisenatide; NA, North America; PPG, postprandial plasma glucose; RoW, rest of the world.