Insulin glargine 300 U/mL in the management of diabetes: clinical utility and patient perspectives

Figures & data

Table 1 Overview of randomized controlled trials on glargine-300

Trial name or first author, year	Population	Countries	Number of participants	Study duration	Primary outcome
EDITION 1,^Citation22 2014	T2DM on basal and mealtime insulin	Canada, Czech Republic, Estonia, Finland, France, Germany, Hungary, Latvia, Mexico, the Netherlands, Romania, Russia, South Africa, and the USA	807	6 months (and 6-month extension)	Change in HbA1c
EDITION 2,^Citation23 2014	T2DM on basal insulin	Canada, Chile, Finland, France, Germany, Hungary, Mexico, Portugal, Romania, Russia, South Africa, Spain, and the USA	811	6 months (and 6-month extension)	Change in HbA1c
EDITION 3,^Citation24 2015	T2DM on oral agents (insulin-naïve)	Canada, USA, Europe (12 countries)	878	6 months	Change in HbA1c
EDITION 4,^Citation25 2015	T1DM	Canada, Czech Republic, Denmark, Estonia, Finland, Hungary, Japan, Latvia, the Netherlands, Romania, Sweden, and the USA	549	6 months	Change in HbA1c
EDITION JP1,^Citation26 2016	T1DM	Japan	243	6 months	Change in HbA1c
EDITION JP2,^Citation27 2016	T2DM on basal insulin	Japan	241	6 months	Change in HbA1c
Jinnouchi et al,^Citation28 2015	T1DM	Japan	20 (cross-over)	28 days	24 hours glucose variability by CGM

Abbreviations: CGM, continuous glucose monitoring; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus; HbA1c, glycated hemoglobin.

Figure 1 Effect of treatment with glargine-300 (blue bars) as compared to glargine-100 (green bars) on the change in HbA1c levels in 6-month EDITION trials in people with type 1 diabetes (EDITION 4 and JP1) or type 2 diabetes (EDITION 1, 2, 3 and JP2).^22–27

Table 2 Nocturnal hypoglycemia in studies on glargine-300

Study, number of participants	Glargine-300	Glargine-100	Relative risk or rate ratio (95% CI)
Type 1 diabetes
EDITION 4, n=549^Citation25
– No of participants (%)	188 (68.6)	193 (70.2)	0.98 (0.88–1.09)
– No of events (per participant-year)	ND (8.0)	ND (9.0)	0.90 (0.71–1.14)
EDITION JP1, n=243^Citation26
– No of participants (%)	84 (68.9)	98 (81.0)	0.85 (0.73–0.99)
– Events (per participant-year)	444 (7.46)	663 (11.24)	0.66 (0.48–0.92)
Jinnouchi et al, n=20 (cross-over)^Citation28
– No of participants (%)	4 (20.0)	8 (40.0)	0.50 (0.18–1.40)*
– No of events (per participant-year)	6 (3.6)	20 (12.0)	0.30 (0.11–0.72)*
Type 2 diabetes
EDITION 1, n=807 (basal-bolus)^Citation22
– No of participants (%)	180 (44.6)	231 (57.5)	0.78 (0.68–0.89)
– No of events (per participant-year)	610 (3.13)	813 (4.20)	0.75 (0.58–0.95)
EDITION 2, n=811 (basal insulin)^Citation23
– No of participants (%)	114 (28.3)	162 (39.9)	0.71 (0.58–0.86)
– No of events (per participant-year)	362 (1.89)	713 (3.68)	0.52 (0.35–0.77)*
EDITION 3, n=878 (insulin-naïve)^Citation24
– No of participants (%)	78 (17.9)	103 (23.5)	0.76 (0.59–0.99)
– No of events (per participant-year)	263 (1.31)	265 (1.34)	0.98 (0.64–1.48)
EDITION JP2, n=241 (basal insulin)^Citation27
– No of participants (%)	34 (28.3)	55 (45.8)	0.62 (0.44–0.88)
– No of events (per participant-year)	129 (2.18)	297 (4.98)	0.45 (0.21–0.96)

Note:

* Calculated on data provided in the paper.

Abbreviations: ND, no data; CI, confidence interval; No, number.

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JinnouchiHKoyamaMAmanoAContinuous glucose monitoring during basal-bolus therapy using insulin glargine 300 U mL(−1) and glargine 100 U mL (−1) in Japanese people with type 1 diabetes mellitus: a crossover pilot studyDiabetes Ther20156214315226055218

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