Table 1.
Changes from baseline and intraclass correlation coefficient values for different measuresa
| Baseline Median (IQR) | Percent change from baseline Median (IQR) | ICC for change from baseline values | Inter‐subject variability, σβ b | Intra‐subject variability, σɛ b | |
|---|---|---|---|---|---|
| BHB, μM | 55 (34;97) | 78 (2;236) | 0.33 | 135 | 193 |
| AcAc, μM | 28 (19;44) | 62 (0;180) | 0.34 | 43 | 60 |
| TKB, μM | 82 (53;141) | 73 (1;216) | 0.33 | 177 | 251 |
| FPG, mmol/L | 8.5 (7.4;9.8) | −17 (−27;–9) | 0.83 | 1.5 | 0.66 |
| HbA1c, % | 7.9 (7.4;8.6) | −11 (−16;–6) | 0.91c | 0.68 | 0.22 |
| FFA, μM | 510 (380;660) | 10 (−15;46) | 0.47 | 149 | 157 |
| Insulin, pmol/L | 47 (30;74) | −22 (−40;2) | 0.73 | 26 | 16 |
| TG, mmol/L | 1.4 (1.0;2.0) | −15 (−33;9) | 0.53 | 0.76 | 0.72 |
| LDL cholesterol, mmol/L | 3.1 (2.6;3.6) | 4 (−6;15) | 0.55 | 0.39 | 0.36 |
| HDL cholesterol, mmol/L | 1.3 (1.1;1.6) | 9 (0;19) | 0.55 | 0.14 | 0.13 |
| UGE, g/g creatinine | 0.15 (0.08;0.66) | 29400 (7900;51500) | 0.68 | 17000 | 12000 |
Abbreviations: AcAc, acetoacetate; BHB, β‐hydroxybutyrate; FFA, free fatty acids; FPG, fasting plasma glucose; HbA1c, glycated haemoglobin; ICC, intraclass correlation coefficient; IQR, interquartile range; TG, triglycerides; TKB, total ketone bodies; UGE, urinary glucose excretion.
a
Data for both canagliflozin doses were pooled in this analysis.
b
The σβ and σɛ values provide measures of inter‐ and intra‐subject variability, respectively, as described in the methods section.
c
For HbA1c, only changes after week 12 were included in the analysis to avoid variability associated with the time lag required for equilibration of HbA1c.