Table 3—

Incidence of adverse events in the safety analyzable population (pooled data from 13 studies (n = 3,702)

NateglinideMetforminGlyburidePlacebo
All patients
n2,204436293769
 Percentage with ≥1 AE60.769.059.461.4
 Percentage with discontinuation for AEs4.76.93.84.3
 Percentage with SAEs (death)3.4 (0.2)3.0 (0.2)5.8 (1.0)4.6 (0)
 Events of hypoglycemia11.17.119.14.4
  Baseline HbA1c <7.5%15.311.632.36.3
 Confirmed hypoglycemia*2.20.76.80.9
  Baseline HbA1c <7.5%3.80.812.51.7
 Gastrointestinal AEs
  Diarrhea2.812.42.03.0
  Nausea2.65.32.03.8
  Dyspepsia1.74.41.42.2
Patients >64 years
n73710492237
 Percentage with ≥1 AE62.676.955.464.1
 Percentage with discontinuation for AEs5.09.66.55.9
 Percentage with SAEs (death)5.7 (0.3)2.9 (0)8.7 (3.3)6.8 (0)
 Events of hypoglycemia9.99.619.65.9
  Baseline HbA1c <7.5%11.57.736.45.8
 Confirmed hypoglycemia*2.206.50.4
  Baseline HbA1c <7.5%3.2012.10.8
 Gastrointestinal AEs
  Diarrhea3.816.31.13.4
  Nausea2.75.82.22.1
  Dyspepsia2.310.603.8
Patients >64 years with RI
n3335138100
 Percentage with ≥1 AE65.266.760.564.0
 Percentage with discontinuation for AEs6.311.810.56.0
 Percentage with serious AEs (death)6.6 (0)0 (0)15.8 (5.3)6.0 (0)
 Events of hypoglycemia10.29.815.86.0
  Baseline HbA1c <7.5%11.06.742.93.6
 Confirmed hypoglycemia*3.007.90
  Baseline HbA1c <7.5%3.9021.40
 Gastrointestinal AEs
  Diarrhea5.413.72.61.0
  Nausea2.79.82.62.1
  Dyspepsia3.011.803.0
  • *

    * Confirmed hypoglycemia: plasma glucose level ≤3.3 mmol/l.

  • RI: calculated creatinine clearance <60 ml/min per 1.73m2.