Table 2

Efficacy and safety results

Efficacy data
Treatment assignmentPlaceboRanolazine
 HbA1c
  n195199
  Baseline mean ± SD (%)8.02 ± 0.7288.06 ± 0.735
  Baseline mean (mmol/mol)6465
  Week 24 mean ± SD (%)7.70 ± 1.1837.26 ± 1.101
  Week 24 mean (mmol/mol)6156
  LS change from baseline mean ± SE (%)−0.20 ± 0.073−0.76 ± 0.073
  LS change from baseline mean (mmol/mol)−2.2−8.3
  Placebo-corrected LS change from baseline mean (95% CI) (%)−0.56 (−0.76, −0.36)
  Placebo-corrected LS change from baseline mean (95% CI) (mmol/mol)−6.1 (−8.3, −3.9)
  P value vs. placebo0.0001
 FSG (mg/dL)
  n191197
  Baseline mean ± SD171 ± 34.6172 ± 34.5
  Week 24 mean ± SD169 ± 40.3165 ± 40.4
  LS change from baseline mean ± SE2 ± 2.7−6 ± 2.6
  Placebo-corrected LS change from baseline mean (95% CI)−8 (−16, −1)
  P value vs. placebo0.0266
 Fasting plasma glucagon (pg/mL)
  n188192
  Baseline mean ± SD86 ± 26.185 ± 28.9
  Week 24 mean ± SD93 ± 32.384 ± 28.5
  LS change from baseline mean ± SE9 ± 1.8−1 ± 1.8
  Placebo-corrected LS change from baseline mean (95% CI)−09 (−14, −4)
  P value vs. placebo0.0003
 Fasting serum insulin (μIU/mL)
  n166168
  Baseline mean ± SD14.84 ± 10.7913.85 ± 9.081
  Week 24 mean ± SD13.18 ± 10.4611.66 ± 7.484
  LS change from baseline mean ± SE−1.04 ± 0.510−2.45 ± 0.509
  Placebo-corrected LS change from baseline mean (95% CI)−1.41 (−2.83, 0.00)
  P value vs. placebo0.0507
 Fasting serum C-peptide (ng/mL)
  n186189
  Baseline mean ± SD2.65 ± 1.1062.55 ± 1.002
  Week 24 mean ± SD2.68 ± 1.1752.46 ± 0.943
  LS change from baseline mean ± SE0.09 ± 0.059−0.11 ± 0.059
  Placebo-corrected LS change from baseline mean (95% CI)−0.20 (−0.36, −0.04)
  P value vs. placebo0.0158
Safety data
 Treatment assignment (n)Placebo (n = 232)Ranolazine (n = 232)
 AEs
  Subjects with any AE, n (%)89 (38.4%)97 (41.8%)
  Hyperglycemia, n (%)23 (9.9%)19 (8.2%)
  Constipation, n (%)10 (4.3%)12 (5.2%)
  Nausea, n (%)2 (0.9%)9 (3.9%)
  Dizziness, n (%)2 (0.9%)6 (2.6%)
 AEs related to study drug
  Subjects with any related AE, n (%)9 (3.9%)21 (9.1%)
  Constipation, n (%)3 (1.3%)5 (2.2%)
  Headache, n (%)2 (0.9%)6 (2.6%)
  Dizziness, n (%)1 (0.4%)5 (2.2%)
 SAEs, n (%)7 (3.0%)6 (2.6%)
 AE leading to premature study drug discontinuation, n (%)8 (3.4%)12 (5.2%)
 Deaths during study, n (%)01 (0.4%)
  • P value indicates difference in placebo-corrected LSM change from baseline; n of change from baseline at week 24. LS, least squares; SAEs, serious adverse events.