Table 2 Clinical responses of study groups to lixisenatide add-on treatment to basal insulin therapy ± oral antidiabetic drugs
Subgroups | BMI <25 kg/m2 | BMI 25–<30 kg/m2 | BMI 30–<35 kg/m2 | BMI ≥35 kg/m2 | p value |
|---|---|---|---|---|---|
HbA1c, % (SD) | |||||
Baseline | 8.23 (0.81) | 8.24 (0.82) | 8.06 (0.92) | 8.06 (0.84) | 0.07* |
Week 24 | 7.61 (1.25) | 7.56 (1.17) | 7.38 (1.07) | 7.33 (1.09) | 0.10* |
Mean change from baseline | −0.63 (1.19) | −0.68 (1.08) | −0.68 (0.92) | −0.73 (0.92) | 0.88* |
Patients with endpoint HbA1c n (%) | 0.09** | ||||
<7 % | 47 (35.3) | 77 (34.7) | 69 (41.6) | 66 (46.8) | |
≥7 % | 86 (64.7) | 145 (65.3) | 97 (58.4) | 75 (53.2) | |
FPG mg/dL (SD) | |||||
Baseline | 129.2 (41.1) | 133.7 (44.2) | 136.5 (40.7) | 137.7 (41.7) | 0.35* |
Week 24 | 132.5 (46.9) | 135.4 (54.2) | 132.7 (42.5) | 135.6 (45.3) | 0.90* |
Mean change from baseline | 3.2 (52.7) | 1.7 (59.8) | −3.9 (46.6) | −2.1 (40.8) | 0.60* |
Patients with endpoint FPG n (%) | 0.63** | ||||
<110 mg/dL | 48 (36.6) | 81 (37.2) | 54 (32.5) | 44 (31.7) | |
≥110 mg/dL | 83 (63.4) | 137 (62.8) | 112 (67.5) | 95 (68.4) | |
PPG mg/dL (SD)a | |||||
Baseline | 301.5 (75.2) | 287.5 (77.3) | 279.0 (82.2) | 252.6 (75.2) | <0.0001* |
Week 24 | 175.0 (86.8) | 184.7 (83.8) | 197.3 (82.0) | 185.5 (68.9) | 0.15* |
Mean change from baseline | −126.6 (109.7) | −103.5 (109.2) | −82.0 (103.1) | −67.2 (84.0) | <0.0001* |
Percent change from baseline | −42 % | −36 % | −29 % | −27 % | |
Basal insulin dose U (SD) | |||||
Baseline | 26.2 (11.6) | 36.5 (15.5) | 50.3 (24.8) | 63.9 (41.2) | <0.0001* |
Week 24 | 25.5 (12.1) | 36.2 (17.0) | 50.4 (26.1) | 62.1 (31.6) | <0.0001* |
Mean change from baseline | −0.7 (4.8) | −0.3 (6.8) | 0.2 (10.0) | −1.8 (29.8) | 0.72* |
Body weight kg (SD) | |||||
Baseline | 61.0 (9.0) | 73.8 (9.9) | 88.9 (11.8) | 110.4 (18.6) | <0.0001* |
Week 24 | 60.8 (9.3) | 73.1 (10.0) | 87.9 (12.2) | 109.4 (19.1) | <0.0001* |
Mean change from baseline | −0.2 (2.0) | −0.7 (2.4) | −1.0 (3.3) | −1.0 (3.5) | 0.06* |
BMI kg/m2 (SD) | |||||
Baseline | 23.1 (1.5) | 27.6 (1.5) | 32.4 (1.4) | 40.3 (5.0) | |
Week 24 | 23.1 (1.7) | 27.4 (1.7) | 32.0 (1.8) | 39.9 (5.3) | <0.0001* |
Mean change from baseline | −0.1 (0.8) | −0.2 (0.9) | −0.4 (1.2) | −0.4 (1.3) | 0.07* |