Outcome variables
| Saxagliptin group N=33 | Basal-bolus insulin group N=33 | p Value* | |
|---|---|---|---|
| Mean BG on day 1 mg/dL | 154.8±28.2 | 156.0±32.1 | 1.0 |
| Mean daily BG day 2-5 mg/dL† | 149.8±22.0 | 146.9±30.5 | 0.59 |
| BGs in 70–140, N (%) | 102 (42) | 105 (37) | 0.16 |
| Number of patient days with at least one BG >200, N (%) | 14 (15) | 22 (19) | 0.27 |
| BGs >200, N (%) | 17 (6) | 31 (10) | 0.16 |
| Number of patient days with at least one BG <70 | 1 | 1 | |
| BGs <70 (%) | 0.4 | 0.3 | NS |
| Number of patient days with at least one BG <50 | 0 | 0 | |
| BGs <50 (%) | 0 | 0 | |
| LOS, days | 8.0±14.6 | 6.4±5.4 | 0.87 |
| Mean daily insulin dose, units | |||
| Total | 2.4±3.3 | 13.3±12.9 | <0.001 |
| Basal | 0 | 6.1±7.2 | |
| Bolus | 2.4±3.3 | 7.4±7.1 | <0.001 |
| Mean number of injections per day | 1.2±1.9 | 2.3±1.7 | <0.001 |
| DTSQ IP composite score (range 0–84) | 70±12 | 75±11 | 0.19 |
| DTSQ IP Q2+Q3 score (range 0–12) | 3.9±3.7 | 2.5±3.0 | 0.12 |
*Tests of superiority include the Wilcoxon rank sum test and χ2 test.
†Main study outcome for the non-inferiority test. With group difference of 2.9 mg/dL and a priori margin of 20 mg/dL, we reject inferiority of saxagliptin in favor of non-inferiority (p=0.007).
BG, blood glucose.