TABLE 3.
Summary of changes in continuous glucose monitoring (CGM) variables from baseline at week 12
| Evogliptin | Linagliptin | P‐value | |||
|---|---|---|---|---|---|
| (n = 100) | (n = 104) | ||||
| Mean glucose for 0‐24 h (mg/dL) | |||||
| Baseline (n, mean ± SD) | 82 a | 164.2 ± 34.2 | 87 a | 165.2 ± 32.3 | |
| At week 12 (n, mean ± SD) | 77 b | 146.6 ± 28.2 | 68 b | 142.8 ± 24.8 | |
| Change from baseline to week 12 (n, mean ± SD) | 68 | −17.3 ± 27.5 | 62 | −19.0 ± 29.9 | .660 e |
| P‐value for mean difference | <.0001 c | <.0001 f | |||
| SD (mg/dL) | |||||
| Baseline (n, mean ± SD) | 82 a | 36.8 ± 12.0 | 87 a | 36.2 ± 12.6 | |
| At week 12 (n, mean ± SD) | 77 b | 27.8 ± 10.4 | 68 b | 27.0 ± 9.7 | |
| Change from baseline to week 12 (n, mean ± SD) | 68 | −9.8 ± 12.7 | 62 | −8.3 ± 11.6 | .482 d |
| P‐value for mean difference | <.0001 c | <.0001 c | |||
| Mean amplitude of glucose excursions | |||||
| Baseline (n, mean ± SD) | 82 a | 95.1 ± 29.4 | 87 a | 90.0 ± 28.5 | |
| At week 12 (n, mean ± SD) | 77 b | 71.6 ± 25.9 | 68 b | 70.2 ± 25.0 | |
| Change from baseline to week 12 (n, mean ± SD) | 68 | −24.6 ± 34.5 | 62 | −16.7 ± 29.7 | .166 d |
| P‐value for mean difference | <.0001 c | <.0001 c | |||
| Coefficient of variance (%) | |||||
| Baseline (n, mean ± SD) | 82 a | 22.4 ± 5.6 | 87 a | 21.9 ± 6.2 | |
| At week 12 (n, mean ± SD) | 77 b | 19.0 ± 6.2 | 68 b | 18.8 ± 5.7 | |
| Change from baseline to week 12 (n, mean ± SD) | 68 | −3.9 ± 7.1 | 62 | −3.0 ± 6.0 | .464 d |
| P‐value for mean difference | <.0001 c | .0002 c | |||
| Mean of daily differences (mg/dL) | |||||
| Baseline (n, mean ± SD) | 82 a | 32.6 ± 16.0 | 87 a | 31.9 ± 11.6 | |
| At week 12 (n, mean ± SD) | 77 b | 25.5 ± 11.1 | 68 b | 24.9 ± 9.6 | |
| Change from baseline to week 12 (n, mean ± SD) | 68 | −7.2 ± 15.6 | 62 | −6.4 ± 13.0 | .759 d |
| P‐value for mean difference | .0003 c | .0002 c | |||
| Proportion of time in hypoglycaemia (< 54 mg/dL) | |||||
| Baseline (n, mean ± SD) | 82 a | 0.08 ± 0.58 | 87 a | 0.07 ± 0.44 | |
| At week 12 (n, mean ± SD) | 77 b | 0.22 ± 1.15 | 68 b | 0.24 ± 1.10 | |
| Change from baseline to week 12 (n, mean ± SD) | 68 | 0.06 ± 1.23 | 62 | 0.17 ± 1.28 | .522 e |
| P‐value for mean difference | .8750 f | .4688 f | |||
| Proportion of time in hypoglycaemia (<70 mg/dL) | |||||
| Baseline (n, mean ± SD) | 82 a | 0.45 ± 2.04 | 87 a | 0.69 ± 2.30 | |
| At week 12 (n, mean ± SD) | 77 b | 0.42 ± 1.73 | 68 b | 0.65 ± 2.37 | |
| Change from baseline to week 12 (n, mean ± SD) | 68 | −0.19 ± 2.66 | 62 | −0.05 ± 2.71 | .927 e |
| P‐value for mean difference | .5342 f | .4729 f | |||
| Proportion of time in range (70‐180 mg/dL) | |||||
| Baseline (n, mean ± SD) | 82 a | 67.7 ± 26.0 | 87 a | 68.1 ± 22.6 | |
| At week 12 (n, mean ± SD) | 77 b | 81.6 ± 22.3 | 68 b | 84.6 ± 18.6 | |
| Change from baseline to week 12 (n, mean ± SD) | 68 | 13.9 ± 21.8 | 62 | 15.0 ± 23.7 | .390 e |
| P‐value for mean difference | <.0001 f | <.0001 f | |||
| Proportion of time in hyperglycaemia (>180 mg/dL) | |||||
| Baseline (n, mean ± SD) | 82 a | 31.9 ± 26.2 | 87 a | 31.2 ± 23.1 | |
| At week 12 (n, mean ± SD) | 77 b | 18.0 ± 22.5 | 68 b | 14.7 ± 18.4 | |
| Change from baseline to week 12 (n, mean ± SD) | 68 | −13.7 ± 21.8 | 62 | −14.9 ± 23.8 | .413 e |
| P‐value for mean difference | <.0001 f | <.0001 f | |||
| Proportion of time in hyperglycaemia (>250 mg/dL) | |||||
| Baseline (n, mean ± SD) | 82 a | 7.2 ± 11.0 | 87 a | 6.6 ± 12.7 | |
| At week 12 (n, mean ± SD) | 77 b | 2.6 ± 6.7 | 68 b | 1.6 ± 5.9 | |
| Change from baseline to week 12 (n, mean ± SD) | 68 | −4.9 ± 9.6 | 62 | −3.0 ± 10.0 | .805 e |
| P‐value for mean difference | <.0001 f | .0014 f | |||
Abbreviation: SD, standard deviation.
a
Subjects whose measurement data of 0‐24 h on day −2 and day −1 at week 0 were all available.
b
Subjects whose measurement data of 0‐24 h on day ‐2 and day ‐1 at week 12 were all available.
c
P‐values were derived from a paired t‐test.
d
P‐values were derived from a two‐sample t‐test.
e
P‐values were derived from a Wilcoxon rank‐sum test.
f
P‐values were derived from a Wilcoxon signed‐rank test.