Table 2.
Clinical responses to lixisenatide (LIXI) or placebo (PBO) add-on treatment to basal insulin therapy±oral antidiabetic drugs in the overall pooled population and by baseline body mass index (BMI) subgroup
| BMI <25 kg/m2 | BMI 25–<30 kg/m2 | BMI ≥30 kg/m2 | All pooled participants | Interaction P value |
|||||
| PBO (n=79) |
LIXI (n=104) |
PBO (n=142) |
LIXI (n=134) |
PBO (n=42) |
LIXI (n=54) |
PBO (n=263) |
LIXI (n=291) |
||
| HbA1c, % | |||||||||
| Mean±SD at baseline | 7.89±0.67 | 8.00±0.73 | 7.97±0.72 | 8.01±0.78 | 8.10±0.84 | 7.97±0.77 | 7.97±0.73 | 8.00±0.76 | 0.345 |
| Mean±SD at week 24 | 8.08±1.20 | 7.57±1.09 | 7.88±0.98 | 7.57±1.28 | 8.21±1.24 | 7.46±1.21 | 7.99±1.10 | 7.55±1.20 | |
| LSM±SE change from baseline | 0.29±0.14 | –0.33±0.13 | –0.11±0.12 | –0.53±0.11 | –0.04±0.19 | –0.61±0.17 | 0.02±0.08 | –0.49±0.08 | |
| LSM difference (95% CI) | –0.62 (–0.93 to –0.31) | –0.42 (–0.67 to –0.17) | –0.58 (–1.02 to –0.13) | –0.51 (–0.68 to –0.33) | |||||
| P value | <0.001 | 0.001 | 0.013 | <0.001 | |||||
| HbA1c <7% at week 24, n (%) | 9 (11.4) | 34 (33.3) | 21 (15.0) | 42 (33.1) | 4 (9.5) | 18 (34.0) | 34 (13.0) | 94 (33.3) | 0.852 |
| Risk difference (SE) | 21.9 (5.9) | 18.1 (5.2) | 24.4 (7.9) | 20.3 (3.5) | |||||
| OR (95% CI) | 5.98 (2.24 to 15.97) | 4.18 (2.08 to 8.37) | 4.71 (1.20 to 18.51) | 4.35 (2.66 to 7.12) | |||||
| P value | <0.001 | <0.001 | 0.027 | <0.001 | |||||
| FPG, mmol/L | |||||||||
| Mean±SD at baseline | 6.81±1.81 | 7.12±2.31 | 6.71±1.83 | 7.17±2.25 | 7.14±2.09 | 6.80±1.70 | 6.81±1.86 | 7.08±2.18 | 0.156 |
| Mean±SD at week 24 | 7.49±2.23 | 7.19±2.13 | 7.31±2.23 | 7.63±2.82 | 8.60±2.55 | 7.14±2.45 | 7.57±2.32 | 7.38±2.52 | |
| LSM±SE change from baseline | 0.45±0.30 | 0.06±0.27 | 0.57±0.26 | 0.48±0.25 | 1.09±0.42 | –0.12±0.38 | 0.58±0.17 | 0.23±0.16 | |
| LSM difference (95% CI) | –0.39 (–1.03 to 0.25) | –0.10 (–0.65 to 0.46) | –1.21 (–2.21 to –0.21) | –0.34 (–0.72 to 0.03) | |||||
| P value | 0.234 | 0.731 | 0.019 | 0.074 | |||||
| 2-hour PPG, mmol/L | |||||||||
| Mean±SD at baseline | 14.02±3.51 | 14.79±5.01 | 14.17±3.92 | 13.90±4.19 | 13.82±3.61 | 12.68±3.87 | 14.07±3.74 | 13.99±4.49 | 0.180 |
| Mean±SD at week 24 | 14.84±4.34 | 10.58±5.16 | 13.8±3.95 | 10.76±4.48 | 13.94±3.79 | 10.22±5.46 | 14.14±4.06 | 10.60±4.90 | |
| LSM±SE change from baseline | –0.42±0.67 | –4.63±0.62 | –1.07±0.49 | –4.20±0.49 | 0.04±0.95 | –3.34±0.83 | –0.59±0.36 | –4.11±0.34 | |
| LSM difference (95% CI) | –4.21 (–5.71 to –2.71) | –3.13 (–4.18 to –2.08) | –3.38 (–5.66 to –1.11) | –3.52 (–4.31 to –2.73) | |||||
| P value | <0.001 | <0.001 | 0.004 | <0.001 | |||||
| 2-hour PPG excursion, mmol/L | |||||||||
| Mean±SD at baseline | 7.29±3.64 | 7.62±4.10 | 7.27±3.24 | 6.72±3.34 | 6.44±2.67 | 5.52±3.53 | 7.15±3.29 | 6.81±3.72 | 0.162 |
| Mean±SD at week 24 | 7.43±3.89 | 3.60±5.00 | 6.63±3.46 | 3.39±4.04 | 5.45±3.45 | 3.14±4.14 | 6.70±3.64 | 3.42±4.40 | |
| LSM±SE change from baseline | –0.88±0.63 | –4.46±0.59 | –1.45±0.45 | –4.48±0.45 | –0.97±0.78 | –2.95±0.67 | –1.04±0.33 | –4.13±0.31 | |
| LSM difference (95% CI) | –3.58 (–4.98 to –2.18) | –3.03 (–3.99 to –2.08) | –1.98 (–3.83 to –0.13) | –3.09 (–3.81 to –2.38) | |||||
| P value | <0.001 | <0.001 | 0.036 | <0.001 | |||||
| Body weight, kg | |||||||||
| Mean±SD at baseline | 62.00±7.41 | 61.76±7.33 | 72.88±9.92 | 73.63±9.69 | 89.39±10.49 | 85.57±11.77 | 72.28±12.89 | 71.60±12.67 | 0.726 |
| Mean±SD at week 24 | 62.62±7.70 | 61.41±7.69 | 73.09±10.65 | 72.64±9.91 | 89.36±10.25 | 84.64±11.83 | 72.58±13.07 | 70.85±12.67 | |
| LSM±SE change from baseline | 0.63±0.25 | –0.28±0.23 | 0.35±0.28 | –0.78±0.27 | 0.25±0.48 | –0.71±0.44 | 0.39±0.18 | –0.61±0.17 | |
| LSM difference (95% CI) | –0.92 (–1.44 to –0.39) | –1.14 (–1.71 to –0.56) | –0.96 (–2.12 to 0.19) | –1.00 (–1.38 to –0.62) | |||||
| P value | <0.001 | <0.001 | 0.100 | <0.001 | |||||
| BMI, kg/m2 | |||||||||
| Mean±SD at baseline | 23.07±1.24 | 23.22±1.31 | 27.36±1.46 | 27.13±1.40 | 33.38±2.53 | 32.91±2.54 | 27.05±3.73 | 26.80±3.79 | 0.779 |
| Mean±SD at week 24 | 23.29±1.31 | 23.07±1.40 | 27.43±1.71 | 26.77±1.61 | 33.39±2.60 | 32.56±2.85 | 27.15±3.74 | 26.52±3.81 | |
| LSM±SE change from baseline | 0.22±0.09 | –0.12±0.08 | 0.05±0.10 | –0.36±0.10 | 0.13±0.19 | –0.24±0.17 | 0.12±0.07 | –0.25±0.06 | |
| LSM difference (95% CI) | –0.34 (–0.54 to –0.15) | –0.41 (–0.63 to –0.20) | –0.37 (–0.81 to 0.07) | –0.37 (–0.51 to –0.23) | |||||
| P value | <0.001 | <0.001 | 0.101 | <0.001 | |||||
FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; LSM, least squares mean; PPG, postprandial glucose.