Table 1

Efficacy end points, week 12 (LOCF) (ITT population)

Efficacy end pointSitagliptin + imeglimin 1,500 mg b.i.d. (N = 81)Sitagliptin + placebo
(N = 88)
A1C % [mmol/mol]
 Baseline8.47 [69] (0.72)8.53 [70] (0.66)
  Week 12/end of treatment7.83 [62] (0.9)8.61 [71] (0.95)
 Change from baseline to week 12 (LOCF)*−0.6 (0.11)0.12 (0.10)
  P value compared with placebo<0.001
FPG (mmol/L)10.91 (2.31)
 Baseline10.53 (2.09)
  Week 12/end of treatment9.74 (2.39)10.69 (2.07)
 Change from baseline to week 12 (LOCF)*−0.93 (0.31)−0.11 (0.29)
  P value compared with placebo0.014
Insulin (μIU/mL)
 Baseline9.31 (8.24)12.5 (32.01)
  Week 12/end of treatment8.95 (7.34)10.58 (14.36)
 Change from baseline to week 12 (LOCF)*−1.17 (0.78)−0.81 (0.72)
  P value compared with placebo0.655
C-peptide (ng/mL)
 Baseline3.48 (1.43)3.32 (1.54)
  Week 12/end of treatment3.58 (1.56)3.47 (1.67)
 Change from baseline to week 12 (LOCF)*0.17 (0.13)0.23 (0.12)
  P value compared with placebo0.663
Proinsulin/insulin ratio
 Baseline534.69 (305.21)642.52 (553.34)
  Week 12/end of treatment462.6 (308.22)557.58 (527.8)
 Change from baseline to week 12 (LOCF)*−120.51 (46.98)−80.98 (43.93)
  P value compared with placebo0.428
HOMA-IR
 Baseline5.14 (4.8)5.22 (4.98)
  Week 12/end of treatment4.46 (3.59)5.52 (7.02)
 Change from baseline to week 12 (LOCF)*−0.184 (0.68)0.098 (0.64)
  P value compared with placebo0.572
Triglycerides (mmol/L)
 Baseline2.35 (1.36)2.36 (1.45)
  Week 12/end of treatment2.26 (1.50)2.55 (2.17)
 Change from baseline to week 12 (LOCF)*−0.167 (0.19)0.161 (0.18)
  P value compared with placebo0.106
hs-CRP (mg/L)
 Baseline4.04 (5.58)4.64 (4.87)
  Week 12/end of treatment3.42 (4.94)4.75 (4.82)
 Change from baseline to week 12 (LOCF)*−1.16 (0.64)0.009 (0.59)
  P value compared with placebo0.082
Systolic blood pressure (mmHg)
 Baseline132.0 (10.2)132.8 (10.3)
  Week 12/end of treatment132.8 (10.3)135.9 (9.2)
 Change from baseline to week 12 (LOCF)*1.02.8
  Change compared with placebo−1.8
Diastolic blood pressure (mmHg)
 Baseline79.3 (7.1)80.7 (6.6)
  Week 12/end of treatment80.2 (6.8)81.3 (7.2)
 Change from baseline to week 12 (LOCF)*0.90.6
  Change compared with placebo0.3
  • Data are the mean (SD), unless otherwise stated.

  • *Data are the LS mean (SE) or mean difference.