A comparison of the clinical courses of type 2 diabetic patients whose basal insulin preparation was replaced from insulin glargine 100 units/mL to insulin glargine biosimilar or 300 units/mL: a propensity score-matched observation study

Figures & data

Figure 1. Flowchart of patient selection. IGlar: insulin glargine, U100: 100 U/mL, and U300: 300 U/mL.

Figure 2. Distribution of propensity scores before and after propensity matching. IGlar: insulin glargine and U300: 300 U/mL.

Table 1. Clinical characteristics of the patients at the baseline.

	Before matching			After matching
	IGlar biosimilar	IGlar U300	p	IGlar biosimilar	IGlar U300
	(n = 45)	(n = 149)		(n = 34)	(n = 102)	p
Male subjects (%)	67	62	.55	62	63	.92
Age (years)	61 ± 12	67 ± 12	<.01	65 ± 11	65 ± 12	.87
Duration of diabetes (years)	12 ± 9	16 ± 11	.03	14 ± 8	15 ± 10	.99
Body mass index (kg/m^2)	25.8 ± 5.6	25.4 ± 4.2	.92	25.2 ± 5.3	25.9 ± 4.2	.42
Body weight (kg)	69.1 ± 17.1	66.0 ± 13.7	.44	65.9 ± 15.5	67.9 ± 13.7	.29
Dose of basal insulin (unit/day)	10.6 ± 5.8	13.7 ± 7.6	.01	11.6 ± 6.2	12.0 ± 6.3	.67
Dose of bolus insulin (unit/day)	7.1 ± 8.6	10.0 ± 11.1	.16	8.6 ± 9.2	8.7 ± 10.0	.95
Dose of total insulin (unit/day)	17.7 ± 11.9	23.7 ± 14.6	.01	20.2 ± 12.4	20.7 ± 13.4	.96
HbA1c (%)	7.8 ± 1.1	8.1 ± 1.4	.28	7.9 ± 1.1	7.9 ± 1.2	.68
Hypoglycemia within the past 6 months (%)	9	16	.21	12	13	.88
Concomitant anti-diabetic agents (%)
Sulfonylureas	2	3	.86	3	4	.79
Biguanides	38	29	.26	32	33	.92
Thiazolidinediones	4	2	.40	3	3	.00
α-glucosidase inhibitors	11	9	.55	12	8	.50
DPP-4 inhibitors	56	41	.08	47	46	.92
SGLT2 inhibitors	16	10	.16	12	10	.75
GLP-1 receptor agonists	7	10	.48	6	10	.47
Number of concomitant anti-diabetic agents	1.4 ± 1.1	1.0 ± 0.8	.05	1.2 ± 1.1	1.1 ± 0.8	.98

Abbreviations. IGlar, insulin glargine; DPP-4, dipeptidyl peptidase-4; SGLT2, sodium glucose co-transporter 2; GLP-1, glucagon-like peptide-1.

Figure 3. Changes in the HbA1c levels and body weight during the observation period. Closed circles and open squares indicate glargine biosimilar and glargine U300, respectively.

Table 2. Changes in the clinical parameters during the observation period.

	IGlar biosimilar (n = 34)			IGlar U300 (n = 102)
	Baseline	6 months	p	Baseline	6 months	p
Body mass index (kg/m^2)	25.2 ± 5.3	24.9 ± 5.3	.17	25.9 ± 4.2	25.7 ± 4.3	.16
Body weight (kg)	65.9 ± 15.5	65.1 ± 15.2	.18	67.9 ± 13.7	67.6 ± 13.8	.16
Dose of basal insulin (unit/day)	11.6 ± 6.2	11.6 ± 6.9	.91	12.0 ± 6.3	12.8 ± 7.3	<.01
Dose of bolus insulin (unit/day)	8.6 ± 9.2	7.7 ± 9.1	.12	8.7 ± 10.0	8.5 ± 9.6	.50
Dose of total insulin (unit/day)	20.2 ± 12.4	19.3 ± 12.6	.30	20. ±13.4	21.3 ± 14.1	.18
HbA1c (%)	7.9 ± 1.1	7.8 ± 1.0	.48	7.9 ± 1.2	7.8 ± 1.2	.43
Hypoglycemia within the past 6 months (%)	12	12	1.00	13	2	<.01
Addition of anti-diabetic agents (%)	–	6		–	6
Decrease of anti-diabetic agents (%)	–	12		–	9

Abbreviations. IGlar, insulin glargine; U300, 300 U/mL.

Table 3. Association between the change in the HbA1c level and the clinical characteristics at the baseline.

	Univariate		Multivariate
	Correlation coefficient	p	Correlation coefficient	p
Male sex	–0.143	.40
Age (year)	0.013	.05	0.003	.62
Duration of diabetes (year)	0.009	.26
Body mass index (kg/m^2)	–0.004	.81
Body weight (kg)	–0.005	.35
Dose of basal insulin (unit/day)	–0.008	.53
Dose of bolus insulin (unit/day)	–0.004	.64
Dose of total insulin (unit/day)	–0.004	.52
HbA1c at the baseline (%)	–0.347	<.01	–0.337	<.01
Hypoglycemia within the past 6 months before the replacement	–0.306	.21
Replacement to IGlar U300	0.051	.79

Abbreviations. IGlar, insulin glargine; U300, 300 U/mL.

Table 4. Odds ratios of the clinical characteristics at the baseline with the occurrence of hypoglycemia after the replacement of insulin glargine 100 U/mL.

	Univariate		Multivariate
	OR [95% CI]	p	OR [95% CI]	p
Male sex	0.28 [0.04–1.51]	.14
Age (years)	1.00 [0.93–1.07]	.92
Duration of diabetes (years)	0.97 [0.87–1.06]	.54
Body mass index (kg/m^2)	0.86 [0.68–1.05]	.15
Body weight (kg)	0.94 [0.87–1.01]	.08	0.97 [0.90–1.04]	.39
Dose of basal insulin (unit/day)	0.96 [0.81–1.09]	.52
Dose of bolus insulin (unit/day)	1.03 [0.95–1.11]	.35
Dose of total insulin (unit/day)	1.01 [0.95–1.07]	.70
HbA1c at the baseline (%)	1.03 [0.47–1.98]	.94
Hypoglycemia within the past 6 months before the replacement	8.29 [1.42–48.73]	.02	8.04 [1.12–63.12]	.04
Replacement to IGlar U300	0.15 [0.02–0.81]	.03	0.14 [0.02–0.84]	.03

Abbreviations. OR, odds ratio; CI, confidence interval; IGlar U300, insulin glargine 300 U/mL.