Table 2.
Effects of canagliflozin vs placebo added to teneligliptin on primary and secondary endpoints at 24 weeks
| T + P (n = 68) | T + C (n = 70) | ||
|---|---|---|---|
| HbA1c (%) | n | 68 | 70 |
| Baseline | Mean (SD) | 7.87 (0.83) | 8.18 (0.90) |
| Change from baseline | LS mean (SE) | −0.10 (0.10) | −0.97 (0.10) |
| Difference vs placebo | LS mean (95% CI) | −0.88 (−1.15, −0.60) | |
| P value | <.001 | ||
| FPG1 (mg/dL) | n | 67 | 69 |
| Baseline | Mean (SD) | 167.0 (33.6) | 173.9 (30.6) |
| Change from baseline | LS mean (SE) | 3.9 (3.5) | −34.9 (3.4) |
| Difference vs placebo | LS mean (95% CI) | −38.8 (−48.5, −29.2) | |
| P value | <.001 | ||
| Body weight (kg) | n | 67 | 69 |
| Baseline | Mean (SD) | 73.35 (12.98) | 71.68 (15.79) |
| Change from baseline | LS mean (SE) | −0.78 (0.23) | −2.29 (0.22) |
| Difference vs placebo | LS mean (95% CI) | −1.51 (−2.15, −0.88) | |
| P value | <.001 | ||
| Percent change from baseline | LS mean (SE) | −0.99 (0.31) | −3.32 (0.31) |
| Difference (%) vs placebo | LS mean (95% CI) | −2.33 (−3.20, −1.45) | |
| P value | <.001 | ||
| Fasting proinsulin/C‐peptide | n | 67 | 69 |
| Baseline | Mean (SD) | 0.0166 (0.0080) | 0.0176 (0.0089) |
| Change from baseline | LS mean (SE) | 0.0002 (0.0005) | −0.0029 (0.0005) |
| Difference vs placebo | LS mean (95% CI) | −0.0031 (−0.0045, −0.0016) | |
| P value | < .001 | ||
| HOMA2‐%B | n | 67 | 69 |
| Baseline | Mean (SD) | 38.42 (15.47) | 34.20 (14.77) |
| Change from baseline | LS mean (SE) | −2.04 (1.41) | 10.83 (1.38) |
| Difference vs placebo | LS mean (95% CI) | 12.87 (8.95, 16.79) | |
| P value | <.001 | ||
| Fasting glucagon2 (pg/mL) | 67 | 69 | |
| Baseline | Mean (SD) | 121.4 (19.4) | 116.7 (21.3) |
| Change from baseline | LS mean (SE) | 8.5 (2.1) | 5.7 (2.1) |
| Difference vs placebo | LS mean (95% CI) | −2.7 (−8.6, 3.1) | |
| P value | .355 | ||
| Fasting total adiponectin (µg/mL) | n | 61 | 66 |
| Baseline | Mean (SD) | 3.488 (1.686) | 3.594 (1.714) |
| Change from baseline | LS mean (SE) | −0.234 (0.107) | 0.150 (0.103) |
| Difference vs placebo | LS mean (95% CI) | 0.384 (0.090, 0.677) | |
| P value | .011 | ||
| Fasting HMW adiponectin (µg/mL) | n | 61 | 66 |
| Baseline | Mean (SD) | 1.1135 (0.8935) | 1.2381 (0.9480) |
| Change from baseline | LS mean (SE) | 0.0628 (0.0697) | 0.2612 (0.0670) |
| Difference vs placebo | LS mean (95% CI) | 0.1984 (0.0068, 0.3899) | |
| P value | .043 |
LS mean by analysis of covariance (factor: treatment group; covariate: baseline value)
Abbreviations: CI, confidence interval; FPG, fasting plasma glucose; HbA1c, glycated haemoglobin; HMW, high‐molecular weight; HOMA, homeostatic model assessment; LS mean, least squares mean; n, number of patients with values at baseline or week 24 (last observation carried forward); SD, standard deviation; SE, standard error; T + C, teneligliptin plus canagliflozin; T + P, teneligliptin plus placebo.
1
FPG conversion factor: 1 mg/dL = 0.0555 mmol/L.
2
Fasting glucagon conversion factor: 1 pg/mL = 1 ng/L.