Table 3.
Summary of changes in indices of β-cell function from baseline to week 26 (main study)*
| PBO | CANA 100 mg | CANA 300 mg | |
|---|---|---|---|
| HOMA2-%B, n | 116 | 133 | 130 |
| Mean (s.d.) baseline | 59.1 (29.7) | 50.2 (31.5) | 53.5 (29.9) |
| LS mean (s.e.) change | −2.5 (2.1) | 9.9 (2.0) | 20.3 (2.0) |
| Difference versus PBO (95% CI) | 12.4 (6.6, 18.1) | 22.8 (17.0, 28.6) | |
| Proinsulin/insulin ratio, n | 92 | 107 | 92 |
| Mean (s.d.) baseline (pmol/mIU) | 3.8 (2.3) | 3.8 (1.6) | 4.5 (4.1) |
| LS mean (s.e.) change | 0.5 (0.2) | 0.0 (0.2) | −0.3 (0.2) |
| Difference versus PBO (95% CI) | −0.5 (−1.1, 0.2) | −0.8 (−1.4, –0.1) | |
| Proinsulin/C-peptide ratio, n | 111 | 120 | 106 |
| Mean (s.d.) baseline (nmol/nmol) | 0.04 (0.02) | 0.05 (0.02) | 0.05 (0.02) |
| LS mean (s.e.) change | 0.007 (0.00) | −0.003 (0.00) | −0.003 (0.00) |
| Difference versus PBO (95% CI) | −0.01 (−0.02, 0.00) | −0.01 (−0.02, 0.00) | |
| AUCC/AUCG ratio, n† | 35 | 52 | 48 |
| Mean (s.d.) baseline (pmol/mmol) | 200.6 (97.6) | 160.6 (92.7) | 165.3 (66.5) |
| LS mean (s.e.) change | −18.8 (26.7) | 22.2 (25.4) | 31.9 (26.3) |
| Difference versus PBO (95% CI) | 41.0 (19.0, 63.0) | 50.7 (28.5, 72.9) |
AUCC, C-peptide area under the curve; AUCG, glucose area under the curve; CANA, canagliflozin; CI, confidence interval; FS-MMTT, frequently-sampled mixed-meal tolerance test; HOMA, Homeostasis Model Assessment; LS, least squares; PBO, placebo; s.d., standard deviation; s.e., standard error.
*
Statistical comparison for CANA 100 and 300 mg versus PBO not performed (not pre-specified).
†
Assessed only for subjects who participated in the FS-MMTT.