Table 6.
Summary of changes from baseline in glucose-related FS-MMTT end-points and indices of β-cell function at week 26 (LOCF)*
| PBO | CANA 100 mg | CANA 300 mg | |
|---|---|---|---|
| Two-hour PPG, n† | 38 | 46 | 38 |
| Mean ± SD baseline (mmol/l) | 15.5 ± 3.4 | 16.5 ± 3.7 | 16.0 ± 4.0 |
| LS mean ± SE change | –1.1 ± 0.6 | –2.6 ± 0.6 | –3.1 ± 0.6 |
| Difference vs. PBO (95% CI) | –1.5 (–3.0, –0.1) | –2.1 (–3.6, –0.5) | |
| AUCG(0–3 h), n† | 34 | 41 | 36 |
| Mean ± SD baseline (mmol/l·h) | 41.4 ± 8.2 | 44.0 ± 9.3 | 43.3 ± 8.9 |
| LS mean ± SE change | –4.3 ± 1.4 | –6.3 ± 1.3 | –9.2 ± 1.4 |
| Difference vs. PBO (95% CI) | –2.0 (–5.5, 1.6) | –4.9 (–8.5, –1.3) | |
| ΔAUCG(0–3 h), n† | 34 | 41 | 36 |
| Mean ± SD baseline (mmol/l·h) | 13.6 ± 4.5 | 14.5 ± 4.7 | 14.6 ± 4.8 |
| LS mean ± SE change | –1.8 ± 0.8 | –2.5 ± 0.8 | –3.3 ± 0.8 |
| Difference vs. PBO (95% CI) | –0.8 (–2.8, 1.2) | –1.6 (–3.6, 0.5) | |
| HOMA2-%B, n | 129 | 133 | 133 |
| Mean ± SD baseline | 55.4 ± 38.1 | 51.3 ± 32.3 | 53.0 ± 28.0 |
| LS mean ± SE change | –1.0 ± 4.8 | 12.3 ± 4.9 | 25.9 ± 4.8 |
| Difference vs. PBO (95% CI) | 13.3 (1.1, 25.5) | 26.9 (14.7, 39.1) | |
| AUCC(0–3 h), n† | 33 | 41 | 36 |
| Mean ± SD baseline (nmol/l·h) | 4.9 ± 2.0 | 5.3 ± 2.4 | 4.9 ± 2.5 |
| LS mean ± SE change | –0.4 ± 0.2 | –0.1 ± 0.2 | –0.3 ± 0.2 |
| Difference vs. PBO (95% CI) | 0.3 (–0.2, 0.8) | 0.1 (–0.4, 0.7) | |
| AUCC/AUCG ratio, n† | 33 | 40 | 35 |
| Mean ± SD baseline (pmol/mmol) | 123.1 ± 51.6 | 131.7 ± 79.8 | 122.5 ± 72.3 |
| LS mean ± SE change | –3.4 ± 10.6 | 23.7 ± 10.5 | 24.0 ± 11.1 |
| Difference vs. PBO (95% CI) | 27.1 (–0.2, 54.4) | 27.4 (–0.7, 55.6) |
FS-MMTT, frequently-sampled mixed-meal tolerance test; LOCF, last observation carried forward; PBO, placebo; CANA, canagliflozin; PPG, postprandial glucose; SD, standard deviation; LS, least squares; SE, standard error; CI, confidence interval; AUCG, glucose area under the curve; ΔAUCG, incremental glucose area under the curve; HOMA, Homeostasis Model Assessment; AUCC, C-peptide area under the curve.
*
Statistical comparison for CANA 100 and 300 mg vs. PBO not performed (not prespecified).
†
Assessed in patients who participated in the FS-MMTT.