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

Table 2 Risk of hypoglycaemia for Gla-300 vs Gla-100 across the EDITION Phase 3 Clinical Trial Program (Safety population)

Study (ref.)		Confirmed [≤ 3.9 mmol/L (≤ 70 mg/dL)] or severe hypoglycaemia													At any time of the day
		Nocturnal							At any time of the day						Severe hypoglycaemia
		Baseline to Week 8		Week 9 to Month 6			Baseline to Month 6		Baseline to Week 8		Week 9 to Month 6		Baseline to Month 6		Baseline to Month 6
		Gla-300	Gla-100	Gla-300	Gla-100		Gla-300	Gla-100	Gla-300	Gla-100	Gla-300	Gla-100	Gla-300	Gla-100	Gla-300	Gla-100
EDITION 1[15]	Patients (%)	26.2	33.3	36.1	45.8		44.6	57.5	64.4	75.1	74.8	77.6	81.9	87.8	5.0	5.7
	RR (95%CI)	0.79 (0.64-0.98)		0.79 (0.67-0.93)			0.78 (0.68-0.89)		0.86 (0.78-0.94)		0.96 (0.89-1.04)		0.93 (0.88-0.99)		0.87 (0.48-1.55)
EDITION 2[25]	Patients (%)	13.2	24.6	21.6	27.9		28.3	39.9	47.1	60.1	59.3	65.0	70.0	77.3	1.0	1.2
	RR (95%CI)	0.53 (0.39-0.72)		0.77 (0.60-0.97)			0.71 (0.58-0.86)		0.78 (0.69-0.89)		0.91 (0.82-1.02)		0.90 (0.83-0.98)		NA
EDITION 3[26]	Patients (%)	7.4	10.0	15.4	17.1		17.9	23.5	24.1	29.2	39.8	46.3	46.2	52.5	0.9	0.9
	RR (95%CI)	0.74 (0.48-1.13)		0.90 (0.67-1.22)			0.76 (0.59-0.99)		0.83 (0.67-1.03)		0.86 (0.74-1.00)		0.88 (0.77-1.01)		NA
EDITION 4[27]	Patients (%)	46.7	57.1	59.1		55.6	68.6	70.2	88.3	90.2	82.1	84.0	93.1	93.5	6.6	9.5
	RR (95%CI)	0.82 (0.70-0.96)		1.06 (0.92-1.23)			0.98 (0.88-1.09)		0.98 (0.92-1.04)		0.98 (0.91-1.06)		1.00 (0.95-1.04)		0.71 (0.41-1.24)
EDITION JP 1[28]	Patients (%)	43.4	61.2	61.7	73.7		68.9	81.0	86.9	95.0	94.2	93.2	96.7	97.5	5.7	9.9
	RR (95%CI)	0.71 (0.56-0.91)		0.84 (0.70-1.00)			0.85 (0.73-0.99)		0.91 (0.84-0.99)		1.01 (0.95-1.08)		0.99 (0.95-1.04)		0.58 (0.24-1.42)
EDITION JP 2[29]	Patients (%)	13.3	16.7	25.4	43.7		28.3	45.8	37.5	55.0	60.2	72.3	65.0	76.7	2.5	1.7
	RR (95%CI)	0.83 (0.45-1.52)		0.58 (0.40-0.85)			0.62 (0.44-0.88)		0.69 (0.52-0.91)		0.84 (0.70-1.01)		0.86 (0.73-1.01)		1.25 (0.31-4.98)

Relative risk of experiencing ≥ 1 confirmed (blood glucose ≤ 70 mg/dL) or severe episode of hypoglycaemia. CI: Confidence interval; Gla-100: Insulin glargine 100 U/mL; Gla-300: Insulin glargine 300 U/mL; RR: Relative risk.