. | % participants . | RR Gla-300 vs. Gla-100a . | |||
---|---|---|---|---|---|
Confirmed or severe hypoglycemia . | Gla-300 (n = 508) . | Gla-100 (n = 506) . | RR . | 95% CI . | P value (CMH) . |
2200–0859 h | 48.3 | 47.7 | 1.01 | 0.890–1.153 | 0.8415 |
0000–0559 h | 20.2 | 22.5 | 0.90 | 0.706–1.140 | — |
Any time of the day (24 h) | 59.4 | 62.7 | 0.95 | 0.859–1.046 | — |
. | % participants . | RR Gla-300 vs. Gla-100a . | |||
---|---|---|---|---|---|
Confirmed or severe hypoglycemia . | Gla-300 (n = 508) . | Gla-100 (n = 506) . | RR . | 95% CI . | P value (CMH) . |
2200–0859 h | 48.3 | 47.7 | 1.01 | 0.890–1.153 | 0.8415 |
0000–0559 h | 20.2 | 22.5 | 0.90 | 0.706–1.140 | — |
Any time of the day (24 h) | 59.4 | 62.7 | 0.95 | 0.859–1.046 | — |
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.