Table 2. Glycemic and Cardiometabolic Parameters at Week 52.
| Parameter | Tirzepatide | Insulin lispro (n = 708) | |||
|---|---|---|---|---|---|
| 15 mg (n = 236) | 10 mg (n = 238) | 5 mg (n = 242) | Pooled (n = 716) | ||
| Primary end point | |||||
| HbA1c, %a,b | |||||
| Baseline, mean (SD) | 8.80 | 8.80 | |||
| Week 52, mean (95% CI) | 6.69 (−2.2 to −2.0) | 7.67 (−1.3 to −1.0) | |||
| Change from baseline at week 52 (95% CI) | −2.11 (−2.2 to −2.0) | −1.13 (−1.3 to −1.0) | |||
| Difference vs insulin lispro (95% CI) | −0.98 (−1.17 to −0.79) | ||||
| P value | <.001 | ||||
| Confirmatory secondary end points | |||||
| HbA1c, %a,b | |||||
| Baseline, mean (SD) | 8.74 | 8.78 | 8.88 | ||
| Week 52, mean (95% CI) | 6.53 (−2.4 to −2.1) | 6.65 (−2.3 to −2.0) | 6.88 (−2.1 to −1.8) | ||
| Change from baseline at week 52 (95% CI) | −2.27 (−2.4 to −2.1) | −2.15 (−2.3 to −2.0) | −1.92 (−2.1 to −1.8) | ||
| Difference vs insulin lispro (95% CI) | −1.13 (−1.37 to −0.90) | −1.01 (−1.26 to −0.77) | −0.79 (−1.01 to −0.56) | ||
| P value | <.001 | <.001 | <.001 | ||
| Participants met HbA1c target <7.0% at week 52, No. (%)a,c | 172 (73) | 171 (72) | 140 (58) | 483 (68) | 256 (36) |
| Odds ratio vs insulin lispro (95% CI) | 5.2 (3.6 to 7.5) | 5.1 (3.5 to 7.4) | 2.8 (2.0 to 3.9) | 4.2 (3.2 to 5.5) | |
| P value | <.001 | <.001 | <.001 | <.001 | |
| Body weight, kga,b | |||||
| Baseline, mean (SD) | 91.2 | 89.1 | 91.7 | 90.7 | 90.3 |
| Week 52, mean (95% CI) | 79.5 (−11.9 to −10.0) | 81.2 (−10.2 to −8.3) | 83.8 (−7.7 to −5.7) | 81.5 (−9.5 to −8.4) | 93.6 (2.1 to 4.2) |
| Change from baseline at week 52 (95% CI) | −11.0 (−11.9 to −10.0) | −9.2 (−10.2 to −8.3) | −6.7 (−7.7 to −5.7) | −9.0 (−9.5 to −8.4) | 3.2 (2.1 to 4.2) |
| Difference vs insulin lispro (95% CI) | −14.2 (−15.6 to −12.7) | −12.4 (−13.9 to −11.0) | −9.9 (−11.4 to −8.4) | −12.2 (−13.4 to −10.9) | |
| P value | <.001 | <.001 | <.001 | <.001 | |
Abbreviations: HbA1c, glycated hemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein; VLDL, very-low-density lipoprotein.
a
Data presented are using the treatment-regimen estimand.
b
Tested for superiority and controlled for type I error.
c
Tested for superiority; controlled for type I error only for pooled tirzepatide vs insulin lispro.