Table 2

Baseline and change from baseline at Week 30 in glycemic parameters and body weight, and achievement of composite endpoint, for North American and RoW patients in LixiLan-O (A) and LixiLan-L (B)

iGlarLixiiGlarLixisenatide
NA
n=136
RoW
n=332
P valueNA
n=155
RoW
n=311
P valueNA
n=80
RoW
n=153
P value
HbA1c, mmol/mol
 Baseline89.5 (7.5)87.8 (7.8)0.03189.8 (7.8)87.6 (7.3)0.00291.2 (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, %
 Baseline8.19 (0.69)8.03 (0.71)0.0318.22 (0.71)8.01 (0.67)0.0028.34 (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/Ln=115n=315n=132n=298n=62n=134
 Baseline14.60 (3.71)15.41 (3.58)0.04013.88 (3.27)14.93 (3.75)0.00514.53 (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
 Baseline10.07 (2.39)9.79 (2.33)0.2449.76 (2.41)9.75 (2.29)0.9489.85 (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)
 Baseline91.8 (18.0)88.5 (16.8)0.05589.8 (16.8)89.7 (16.2)0.94489.5 (18.2)91.5 (15.2)0.378
 Change from baseline0.3 (4.2)–0.5 (3.4)0.0341.8 (4.1)0.75 (4.1)0.008–1.48 (3.2)–2.74 (3.4)0.006
Insulin dose (units) Week 3040.6 (14.7)38.3 (15.2)0.12840.6 (14.6)39.2 (15.4)0.342N/AN/AN/A
Composite endpoint‡, n (%)35 (25.7)114 (34.3)0.06017 (11.0)71 (22.8)0.00111 (13.8)50 (32.7)<0.001
iGlarLixiiGlar
NA
n=105
RoW
n=261
P valueNA
n=91
RoW
n=274
P value
HbA1c, mmol/mol
 Baseline88.8 (7.8)88.0 (7.3)0.31988.8 (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, %
 Baseline8.12 (0.71)8.05 (0.67)0.3198.12 (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/Ln=86n=246n=81n=259
 Baseline13.78 (3.29)15.23 (3.92)0.00213.59 (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
 Baseline6.91 (2.04)7.49 (1.88)0.0096.90 (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
 Baseline87.6 (14.0)87.9 (14.6)0.83289.7 (16.1)86.2 (14.2)0.053
 Change from baseline–0.4 (3.8)–0.6 (3.0)0.7101.2 (2.9)0.7 (2.7)0.192
Insulin dose, units
 Baseline36.3 (9.1)34.43 (9.2)0.08637.62 (8.0)34.43 (8.7)0.002
 Change from baseline8.7 (11.5)11.49 (10.2)0.0258.77 (9.5)12.37 (9.9)0.003
Composite endpoint‡, n (%)14 (13.3)59 (22.6)0.0289 (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.