Table 2

Effects of imeglimin versus placebo on primary and secondary efficacy end points

ImegliminPlacebo
HbA1c (%), n106106
 Baseline, mean (SD)7.99 (0.764)7.93 (0.684)
 Change from baseline, LSM (SE)−0.72 (0.07)0.15 (0.07)
 Difference vs. placebo, LSM (95% CI)−0.87 (−1.041, −0.691)
P < 0.0001
HbA1c (mmol/mol), n106106
 Baseline, mean (SD)64 (8.4)63 (7.5)
 Change from baseline, LSM (SE)−7.9 (0.8)1.6 (0.8)
 Difference vs. placebo, LSM (95% CI)−9.5 (−11.4, −7.5)
P < 0.0001
FPG (mmol/L), n106106
 Baseline, mean (SD)9.09 (1.587)8.85 (1.370)
 Change from baseline, LSM (SE)−0.31 (0.16)0.71 (0.16)
 Difference vs. placebo, LSM (95% CI)−1.03 (−1.357, −0.700)
P < 0.0001
Fasting proinsulin-to-insulin ratio, n106106
 Baseline, mean (SD)0.1542 (0.08168)0.1816 (0.10990)
 Change from baseline, LSM (SE)−0.0138 (0.0088)0.0036 (0.0092)
 Difference vs. placebo, LSM (95% CI)−0.0173 (−0.03520, 0.00059)
P = 0.0579
Fasting proinsulin-to-c-peptide ratio, n106106
 Baseline, mean (SD)0.0031 (0.00171)0.0034 (0.00149)
 Change from baseline, LSM (SE)−0.0003 (0.0002)0.0002 (0.0002)
 Difference vs. placebo, LSM (95% CI)−0.0005 (−0.00083, −0.00021)
P = 0.0012
HOMA-IR, n106106
 Baseline, mean (SD)2.4700 (1.85368)2.3298 (1.67803)
 Change from baseline, LSM (SE)0.1961 (0.1775)0.1321 (0.1835)
 Difference vs. placebo, LSM (95% CI)0.0640 (−0.30471, 0.43268)
P = 0.7325
QUICKI, n106106
 Baseline, mean (SD)0.3504 (0.03949)0.3546 (0.04408)
 Change from baseline, LSM (SE)0.0017 (0.0033)−0.0076 (0.0034)
 Difference vs. placebo, LSM (95% CI)0.0093 (0.00283, 0.01569)
P = 0.0050
HOMA-β, n106106
 Baseline, mean (SD)21.4532 (13.30453)22.4627 (15.89649)
 Change from baseline, LSM (SE)3.5276 (1.6059)−2.7121 (1.6673)
 Difference vs. placebo, LSM (95% CI)6.2397 (2.96742, 9.51196)
P = 0.0002
  • LSM, least square mean.