Table 1

Percentage of participants experiencing one or more confirmed or severe hypoglycemic events over 26 weeks of treatment (intent-to-treat population)

% participantsRR Gla-300 vs. Gla-100a
Confirmed or severe hypoglycemiaGla-300 (n = 508)Gla-100 (n = 506)RR95% CIP value (CMH)
2200–0859 h48.347.71.010.890–1.1530.8415
0000–0559 h20.222.50.900.706–1.140
Any time of the day (24 h)59.462.70.950.859–1.046
  • Confirmed hypoglycemia defined as ≤3.9 mmol/L (≤70 mg/dL).

  • aRelative risk (RR) stratified by randomization strata of screening HbA1c (<8.0/≥8.0%), randomization strata of previous use of insulin (naive/pretreated), randomization strata of use of sulfonylurea or meglitinides at screening (yes/no), using a Cochran–Mantel–Haenszel (CMH) methodology.