Table 2.
Assessment of Efficacy, Glucose Fluctuation, and Risk for Hypoglycemic Events for Insulin Lispro and Technosphere Insulin Across 100 Virtual Patients Derived from Expected Glucose Profiles After Isocaloric Meal
| Insulin Lispro | TI | |||||
|---|---|---|---|---|---|---|
| At-meal | Premeal | At-meal | At-meal | Postmeal | Split-dose | |
| Uptitration | ||||||
| Titration rule | ||||||
| PPG test time (min) | 120 | 120 | 90 | 150 | 150 | 150 |
| PPG limit (mg/dL) | 160 | 160 | 160 | 160 | 150 | 150 |
| #VP-BG70, uptitration | 45/100 | 30/100 | 1/100 | 3/100 | 4/100 | 5/100 |
| Results final dosing, mean (SD) | ||||||
| Dose (U) or (U TI) | 3.7 (1.7) | 3.7 (1.8) | 21.7 (13.0) | 29.4 (14.9) | 31.1 (15.5) | 31.7 (15.6) |
| PPG2h (mg/dL) | 167 (23) | 162 (20) | 158 (15) | 140 (13) | 134 (14) | 133 (16) |
| MPG6h (mg/dL) | 134 (13) | 134 (12) | 144 (17) | 129 (9) | 126 (9) | 124 (9) |
| PPGAUC4h (mg/dL·min) | 36,000 (3400) | 35,300 (3100) | 35,400 (3400) | 31,800 (2000) | 31,600 (2100) | 31,000 (2300) |
| Tt (%) | 93 (12) | 95 (11) | 91 (15) | 99 (4) | 100 (2) | 100 (1) |
| Ttt (%) | 50 (13) | 52 (15) | 45 (26) | 73 (19) | 78 (18) | 81 (18) |
| Hyporisk-LBGI, final dose | 0.73 (0.71) | 0.55 (0.65) | 0.09 (0.29) | 0.11 (0.26) | 0.19 (0.46) | 0.19 (0.47) |
Individual dose for each patient has been identified using virtual uptitration following the given titration rule. The number of virtual patients with a blood glucose <70 mg/dL during uptitration is given as “#VP-BG70, uptitration.” For the resulting individualized dose, the mean value across 100 virtual patients is given (standard deviation in parenthesis). The risk for hypoglycemia for each treatment/dosing regimen after virtual uptitration is derived using an established metric, the “LBGI.”14,15 The mean LBGI across all 100 virtual patients was calculated (“hyporisk-LBGI, final dose”). Tt and Ttt describe the average time in the given glucose target range (average for 100 virtual patients).
TI, Technosphere® insulin. VP, virtual patient.