Table 2. Changes in Insulin Use and HbA1c, Baseline to End of Study.
|
Overall
(N=415) |
V-Go
(n=169) |
STO
(n=246) |
p-Value | |
| Insulin Dose | ||||
| Baseline TDD (U/day), mean (SD) | 71.3 (26.1)a | 72.2 (27.7) | ||
| Min, Max | 30, 120 | 30, 120 | ||
| Baseline TDD (U/kg), mean (SD) | 0.76 (0.31)a | 0.72 (0.28) | ||
| Min, Max | 0.24, 1.78 | 0.24, 1.74 | ||
| EOS TDD (U/day), mean (SD) | 54.0 (13.3) | 71.8 (28.5) | ||
| Min, Max | 26, 76 | 26, 155 | ||
| EOS TDD (U/kg), mean (SD) | 0.57 (0.16)b | 0.72 (0.28)c | ||
| Min, Max | 0.20, 0.95 | 0.23, 1.50 | ||
| Change (EOS – baseline) TDD (U/kg), mean (SD) | -0.20 (0.27)a,b | 0.00 (0.08)c | ||
| Min, Max | -0.84, 0.40 | -0.56, 0.50 | ||
| p-valued | <.001 | .397 | ||
| HbA1c | ||||
| Baseline HbA1c (%), mean (SD) | 9.6 (1.4) | 9.9 (1.4) | 9.3 (1.3) | <.001e |
| Min, Max | 7.9, 14.2 | 8.0, 14.2 | 7.9, 13.9 | |
| EOS HbA1c (%), mean (SD) | 8.9 (1.6) | 8.9 (1.5) | 8.9 (1.6) | .747e |
| Min, Max | 5.6, 6.0 | 6.3, 15.0 | 5.6, 16.0 | |
| Change (EOS – baseline) HbA1c (%), mean (SD) | -0.7 (1.6) | -1.0 (1.6) | -0.5 (1.6) | .002e |
| Min, Max | -6.8, 5.9 | -6.7, 3.0 | -6.8, 5.9 | |
| p-valuef | <.001 | <.001 | <.001 |
EOS: end of study; HbA1c: glycated hemoglobin; SD: standard deviation; STO: standard treatment optimized; TDD: total daily dose a Excludes 3 patients in the V-Go group for whom baseline insulin data was unavailable b Excludes 4 patients in the V-Go group for whom EOS weight was unavailable c Excludes 10 patients in the STO group for whom EOS weight was unavailable d p-value based on a paired t-test e p-value is based on an independent t-test to test the difference in change in HbA1c values between treatment groups f p-value is based on a paired t-test to test the difference in change in HbA1c values from baseline within each treatment group