Table 3.
Changes in estimated mean levels of continuous endpoints during follow-up and within-group comparisons (T6 versus T0) (EP and PP populations)
| Population | Outcome | Visit | Estimated mean and 95% CI | Estimated mean difference from T0 and 95% CI | Within group p-value* |
|---|---|---|---|---|---|
| EP | FBG (mg/dL) | T0 | 175.3 (165.6, 185.1) | – | – |
| T6 | 157.6 (149.0, 166.2) | −17.7 (−28.3, −7.2) | 0.001 | ||
| Body weight (kg) | T0 | 83.44 (80.93, 85.95) | – | – | |
| T6 | 82.96 (80.48, 85.44) | −0.48 (−1.11, 0.15) | 0.14 | ||
| iGlarLixi dose (IU) | T0 | 18.73 (17.58, 19.88) | – | – | |
| T6 | 23.86 (22.41, 25.31) | 5.14 (3.95, 6.33) | < 0.0001 | ||
| PP | FBG (mg/dL) | T0 | 177.05 (163.83, 190.27) | – | – |
| T6 | 148.6 (140.7, 156.5) | −28.4 (−41.2, −15.7) | <0.0001 | ||
| Body weight (kg) | T0 | 83.27 (79.94, 86.60) | – | – | |
| T6 | 82.06 (78.79, 85.33) | −1.21 (−1.95, −0.47) | 0.002 | ||
| iGlarLixi dose (IU) | T0 | 17.73 (16.49, 18.97) | – | – | |
| T6 | 22.12 (20.35, 23.89) | 4.40 (3.18, 5.62) | <0.0001 |
*Paired t-test derived from linear mixed models for repeated measurements. Statistically significant p-values (p < 0.05) are in bold
EP efficacy population: subset of the intention-to-treat population (ITT) having HbA1c valid values at T0 and T6, PP per-protocol population: subset of EP patients treated according to summary of product characteristics