Efficacy over 26 weeks (mITT population)
| . | iGlarLixi (n = 252) . | GLP-1 RA (n = 253) . |
|---|---|---|
| HbA1c (primary end point) | ||
| Baseline | ||
| % | 7.8 ± 0.6 | 7.8 ± 0.6 |
| mmol/mol | 62 | 62 |
| Week 26 | ||
| % | 6.7 ± 0.8 | 7.4 ± 0.8 |
| mmol/mol | 50 | 57 |
| LS mean change ± SE | −1.0 ± 0.05 | −0.4 ± 0.05 |
| LS mean difference ± SE | −0.6 ± 0.07 | |
| 95% CI | −0.8, −0.5 | |
| P value | <0.0001 | |
| Reached target HbA1c <7% (53 mmol/mol) | ||
| n (%) | 156 (62) | 65 (26) |
| Proportion difference | 36.1 | |
| 95% CI | 28.1, 44.0 | |
| P value | <0.0001 | |
| Reached target HbA1c ≤6.5% (48 mmol/mol) | ||
| n (%) | 102 (41) | 25 (10) |
| Proportion difference | 30.6 | |
| 95% CI | 23.6, 37.6 | |
| P value | <0.0001 | |
| FPG (mg/dL) | ||
| Baseline | 163 ± 38 | 170 ± 35 |
| Week 26 | 124 ± 30 | 156 ± 36 |
| LS mean change ± SE | −41 ± 2 | −11 ± 2 |
| LS mean difference ± SE | −30 ± 3 | |
| 95% CI | −36, −24 | |
| P value | <0.0001 | |
| FPG (mmol/L) | ||
| Baseline | 9.1 ± 2.1 | 9.5 ± 1.9 |
| Week 26 | 6.9 ± 1.7 | 8.7 ± 2.0 |
| LS mean change ± SE | −2.3 ± 0.12 | −0.6 ± 0.12 |
| LS mean difference ± SE | −1.7 ± 0.17 | |
| 95% CI | −2.0, −1.3 | |
| P value | <0.0001 | |
| 2-h PPG during standardized meal test (mg/dL) | ||
| Baseline | 245 ± 60 | 248 ± 58 |
| Week 26 (LOCF) | 174 ± 56 | 227 ± 59 |
| LS mean change (LOCF) ± SE | −71 ± 4 | −20 ± 4 |
| LS mean difference ± SE | −51 ± 5 | |
| 95% CI | −61, −41 | |
| P value | <0.0001 | |
| 2-h PPG during standardized meal test, mmol/L | ||
| Baseline | 13.6 ± 3.3 | 13.8 ± 3.3 |
| Week 26 (LOCF) | 9.7 ± 3.1 | 12.6 ± 3.3 |
| LS mean change (LOCF) ± SE | −4.0 ± 0.2 | −1.1 ± 0.2 |
| LS mean difference ± SE | −2.9 ± 0.29 | |
| 95% CI | −3.4, −2.3 | |
| P value | <0.0001 | |
| HbA1c <7% (53 mmol/mol) with no documented (≤70 mg/dL) symptomatic hypoglycemia, n (%) | 109 (43.3) | 64 (25.3) |
| HbA1c <7% (53 mmol/mol) with no documented (<54 mg/dL) symptomatic hypoglycemia, n (%) | 143 (56.7) | 64 (25.3) |
| . | iGlarLixi (n = 252) . | GLP-1 RA (n = 253) . |
|---|---|---|
| HbA1c (primary end point) | ||
| Baseline | ||
| % | 7.8 ± 0.6 | 7.8 ± 0.6 |
| mmol/mol | 62 | 62 |
| Week 26 | ||
| % | 6.7 ± 0.8 | 7.4 ± 0.8 |
| mmol/mol | 50 | 57 |
| LS mean change ± SE | −1.0 ± 0.05 | −0.4 ± 0.05 |
| LS mean difference ± SE | −0.6 ± 0.07 | |
| 95% CI | −0.8, −0.5 | |
| P value | <0.0001 | |
| Reached target HbA1c <7% (53 mmol/mol) | ||
| n (%) | 156 (62) | 65 (26) |
| Proportion difference | 36.1 | |
| 95% CI | 28.1, 44.0 | |
| P value | <0.0001 | |
| Reached target HbA1c ≤6.5% (48 mmol/mol) | ||
| n (%) | 102 (41) | 25 (10) |
| Proportion difference | 30.6 | |
| 95% CI | 23.6, 37.6 | |
| P value | <0.0001 | |
| FPG (mg/dL) | ||
| Baseline | 163 ± 38 | 170 ± 35 |
| Week 26 | 124 ± 30 | 156 ± 36 |
| LS mean change ± SE | −41 ± 2 | −11 ± 2 |
| LS mean difference ± SE | −30 ± 3 | |
| 95% CI | −36, −24 | |
| P value | <0.0001 | |
| FPG (mmol/L) | ||
| Baseline | 9.1 ± 2.1 | 9.5 ± 1.9 |
| Week 26 | 6.9 ± 1.7 | 8.7 ± 2.0 |
| LS mean change ± SE | −2.3 ± 0.12 | −0.6 ± 0.12 |
| LS mean difference ± SE | −1.7 ± 0.17 | |
| 95% CI | −2.0, −1.3 | |
| P value | <0.0001 | |
| 2-h PPG during standardized meal test (mg/dL) | ||
| Baseline | 245 ± 60 | 248 ± 58 |
| Week 26 (LOCF) | 174 ± 56 | 227 ± 59 |
| LS mean change (LOCF) ± SE | −71 ± 4 | −20 ± 4 |
| LS mean difference ± SE | −51 ± 5 | |
| 95% CI | −61, −41 | |
| P value | <0.0001 | |
| 2-h PPG during standardized meal test, mmol/L | ||
| Baseline | 13.6 ± 3.3 | 13.8 ± 3.3 |
| Week 26 (LOCF) | 9.7 ± 3.1 | 12.6 ± 3.3 |
| LS mean change (LOCF) ± SE | −4.0 ± 0.2 | −1.1 ± 0.2 |
| LS mean difference ± SE | −2.9 ± 0.29 | |
| 95% CI | −3.4, −2.3 | |
| P value | <0.0001 | |
| HbA1c <7% (53 mmol/mol) with no documented (≤70 mg/dL) symptomatic hypoglycemia, n (%) | 109 (43.3) | 64 (25.3) |
| HbA1c <7% (53 mmol/mol) with no documented (<54 mg/dL) symptomatic hypoglycemia, n (%) | 143 (56.7) | 64 (25.3) |
Data are mean ± SD unless otherwise indicated. LOCF, last observation carried forward.