Glargine-300: An updated literature review on randomized controlled trials and real-world studies

Table 1 Efficacy and safety of Gla-300 vs Gla-100 across the EDITION Phase 3 Clinical Trial Program

Study (ref.) / Registry	Diabetes type	Population	n (Gla-300 vs Gla-100)	Mean baseline A1C (%)	LS mean change in A1C from baseline to Month 6 (%)		TEAEs (%)		Serious TEAEs (%)
					Gla-300	Gla-100	Gla-300	Gla-100	Gla-300	Gla-100
EDITION 1[15], NCT01499082	T2DM	(1) Basal insulin users (≥ 42 U/d); (2) T2DM not adequately controlled; and (3) Basal insulin (evening) + mealtime insulin	807 (404 vs 403)	8.2	-0.83	-0.83	NA	NA	6.4	5.2
					Difference: -0.00%, (95%CI: -0.11 to 0.11)
EDITION 2[25], NCT01499095	T2DM	(1) Basal insulin users (≥ 42 U/d); and (2) Basal insulin (evening) + OADs	811 (404 vs 407)	8.2	-0.57	-0.56	58.8	50.7	3.7	3.7
					Difference: -0.01%, (95%CI: -0.14 to 0.12)
EDITION 3[26], NCT01676220	T2DM	Insulin-naïve (evening), uncontrolled using noninsulin therapy	878 (439 vs 439)	8.5	-1.42	-1.46	NA	NA	5.5	5.9
					Difference: 0.04%, (95%CI -0.09 to 0.17)
EDITION 4[27], NCT01683266	T1DM	Basal insulin (morning or evening) + mealtime insulin	549 (274 vs 275)	8.1	-0.42	-0.44	60.9	58.2	6.2	8.0
					Difference: 0.04%, (95%CI -0.10 to 0.19)
EDITION JP 1[28], NCT01689129	T1DM	(1) Japanese study; and (2) Basal insulin (evening) + mealtime insulin	243 (122 vs 121)	8.1	-0.30	-0.43	62.3	64.5	2.5	2.5
					Difference: 0.13%, (95%CI -0.03 to 0.29)
EDITION JP 2[29], NCT01689142	T2DM	(1) Japanese study; and (2) Basal insulin (evening) + OADs	240 (120 vs 120)	8.0	-0.45	-0.55	58.3	56.7	4.2	3.3
					Difference: 0.10%, (95%CI -0.08 to 0.27)

A1C: Glycated haemoglobin A_1C; CI: Confidence interval; Gla-100: Insulin glargine 100 U/mL; Gla-300: Insulin glargine 300 U/mL; OADs: Oral antidiabetic drugs; T1DM: Type 1 diabetes mellitus; T2DM: Type 2 diabetes mellitus; TEAE: Treatment emergent adverse event.