Table 3. Statistical summary of treatment comparisons for plasma ertugliflozin AUC24 and UGE24 on day 6.
| Parameter (unit) | Comparison (test vs. reference) |
Adjusted (least-squares) geometric means | Ratio (BID:QD) of adjusted means | 90% CI for ratio | |
|---|---|---|---|---|---|
| BID (Test) |
QD (Reference) |
||||
| AUC24, ng×h/mL | Ertugliflozin 2.5 mg BID vs. 5 mg QD | 401.0 | 397.9 | 100.8 | 98.8, 102.8 |
| Ertugliflozin 7.5 mg BID vs. 15 mg QD | 1,190.0 | 1,193.0 | 99.7 | 97.1, 102.5 | |
| UGE24, g | Ertugliflozin 2.5 mg BID vs. 5 mg QD | 57.0 | 51.7 | 110.2 | 103.0, 117.9 |
| Ertugliflozin 7.5 mg BID vs. 15 mg QD | 58.8 | 57.3 | 102.8 | 97.7, 108.1 | |
Adjusted geometric means were obtained using a mixed-effects model (separate for each cohort) with sequence, period, and treatment as fixed effects and subject within sequence as a random effect. The adjusted mean difference and 90% CI were exponentiated to provide estimates of the geometric mean ratio (Test : Reference (BID : QD)) and 90% CI for the ratio. Ratios (and 90% CIs) are expressed as percentages. AUC24 = area under the plasma concentration-time curve over 24 hours; BID = twice daily; CI = confidence interval; QD = once daily; UGE24 = urinary glucose excretion over 24 hours.