Table 3.
Clinical outcomes at study end
| Parameter | Control | Basal plus bolus | p value |
|---|---|---|---|
| n | 57 | 49 | |
| HbA1c | |||
| <7%, n (%) | 5 (8.8) | 11 (22.4) | 0.0499* |
| Total (%) | 7.8 ± 0.9 | 7.5 ± 0.6 | — |
| Adjusted change (%) (Endpoint–randomization) | −0.11 ± 0.08 | −0.37 ± 0.09 | 0.0290† |
| Daily mean PG, mg/dl (mmol/l) | |||
| Randomization | 167.4 ± 39.4 | 170.2 ± 27.9 | — |
| (9.3 ± 2.2) | (9.5 ± 1.6) | ||
| Endpoint | 165.8 ± 37.5 | 154.7 ± 28.6 | — |
| (9.2 ± 2.1) | (8.6 ± 1.6) | ||
| Adjusted change | −2.1 ± 3.4 | −15.0 ± 3.7 | 0.0109† |
| (Endpoint–randomization) | (−0.1 ± 0.2) | (−0.8 ± 0.2) | |
| Daily variability in PG, mg/dl (mmol/l) | |||
| Randomization | 50.6 ± 26.9 | 49.1 ± 18.4 | — |
| (2.8 ± 1.5) | (2.7 ± 1.0) | ||
| Endpoint | 50.0 ± 21.7 | 44.7 ± 21.0 | 0.043‡ |
| (2.8 ± 1.2) | (2.5 ± 1.2) | ||
| Daily insulin dose, U (U/kg) | |||
| Insulin glargine | |||
| Randomization | 55.2 ± 28.3 | 52.8 ± 31.3 | — |
| (0.59 ± 0.26) | (0.57 ± 0.31) | ||
| Endpoint | 62.2 ± 34.9 | 54.7 ± 34.8 | — |
| (0.65 ± 0.32) | (0.59 ± 0.35) | ||
| Insulin glulisine | |||
| Randomization | — | 5.4 ± 1.0 | — |
| (0.06 ± 0.01) | |||
| Endpoint | — | 12.8 ± 6.6 | — |
| (0.14 ± 0.07) | |||
Data are n (%), means ± standard deviation, or adjusted means ± standard error for change.
*
Chi square test.
†
Analysis of covariance (ANCOVA) analysis on change adjusted on randomization value.
‡
ANCOVA analysis on the rank variability at endpoint adjusted on the rank randomization variability. PG, plasma glucose.