Real-World Analysis of Rapid-Acting Insulin Analog Use and Its Blood Glucose Lowering Effect in Patients with Type 2 Diabetes Mellitus: Results from PASSION Disease Registry in Korea

Figures & data

Table 1 Demographic and Clinical Characteristics at Baseline According to Intensification of Insulin Injection

Parameter		RAI 1/Day N=95	RAI ≥2/Day N=204	Total N=299	p-value
Gender	Male	42 (44.21)	114 (55.88)	156 (52.17)	0.0555^a
	Female	53 (55.79)	90 (44.12)	143 (47.83)
DM duration (years)	Mean±SD	9.96±7.22	7.67±7.51	8.31±7.49
	Min~Max	0.17~24.00	0.08~50.00	0.08~50.00
	<4 years	14 (14.74)	46 (22.55)	60 (20.07)
	≥4years ~ <8years	10 (10.53)	41 (20.10)	51 (17.06)
	≥8years ~ <12years	8 (8.42)	25 (12.25)	33 (11.04)
	≥12years	22 (23.16)	27 (13.24)	49 (16.39)
DM complications	Yes	55 (57.89)	90 (44.12)	145 (48.49)	0.0265^b
	No	40 (42.11)	114 (55.88)	154 (51.51)
	Total	95 (100.00)	204 (100.00)	299 (100.00)
DM complications overlapped	Diabetic Retinopathy	25 (26.32)	42 (20.59)	67 (22.41)	0.26881^b
	Diabetic Neuropathy	37 (38.95)	55 (26.96)	92 (30.77)	0.03651^b
	Diabetic Nephropathy	24 (25.26)	31 (15.20)	55 (18.39)	0.03641^b
	Micro-Albuminuria	17 (17.89)	16 (7.84)	33 (11.04)	0.00981^b
	CVD (angina/MI/CHF/Stroke)	10 (10.53)	18 (8.82)	28 (9.36)	0.63801^b
	PVD	2 (2.11)	0 (0.00)	2 (0.67)	0.10022^c
Comorbidity disease	Yes	67 (70.53)	120 (58.82)	187 (62.54)	0.0516^b
	No	28 (29.47)	84 (41.18)	112 (37.46)
	Total	95 (100.00)	204 (100.00)	299 (100.00)
Comorbidity disease overlapped	Hypertension (>130/80 mmHg)	37 (38.95)	74 (36.27)	111 (37.12)	0.6560^b
	Dyslipidemia
	Total cholesterol (6.1 mmol/L)	7 (7.37)	18 (8.82)	25 (8.36)	0.6721^b
	LDL (2.5 mmol/L)	19 (20.00)	27 (13.24)	46 (15.38)	0.1312^b
	HDL (male: <1.0 mmol/L, female: <1.2 mmol/L)	36 (37.89)	42 (20.59)	78 (26.09)	0.0015^b
	TG (>1.6 mmol/L)	32 (33.68)	38 (18.63)	70 (23.41)	0.0042^b
	Other	18 (18.95)	16 (7.84)	34 (11.37)	0.0049^b

Notes: All values are n (%) unless specified otherwise. ^at-test; ^bChi-square test; ^cFisher’s Exact test.

Abbreviations: CHF, congestive heart failure; CVD, cardiovascular disease; DM, diabetes mellitus; HDL, high density lipoprotein; LDL, low density lipoprotein; MI, myocardial infarction; N, number of patients analyzed; PVD, peripheral vascular disease; RAI, rapid-acting insulin; SD, standard deviation; TG, triglyceride.

Figure 1 Selection of the study population. *Overlapped patient, n=1; patient administered prior to the contract date, n=1; written consent form unavailable, n=3; inclusion criteria violation, n=59; contents of investigation unclear, n=32; HbA1c not available, n=53. **Three patients did not have HbA1c measurements, as they were not administered insulin or oral hypoglycemic agents at Visit.

Abbreviations: HbA1c, glycated hemoglobin; n, number of patients analyzed; N, total number of patients.

Table 2 Changes in HbA1c, FPG, PPG, and Body Weight with Use of Insulin Glulisine

	Glycemic Indicators N=270
	HbA1c (%)		FPG (mg/dl)		PP2BG (mg/dl)		PP2PG (mg/dl)		BW (kg)
	n	Mean±SD	n	Mean±SD	n	Mean±SD	n	Mean±SD	n	Mean±SD
Visit 1	270	9.56±1.98	77	203.92±85.55	66	312.67±104.69	46	245.11±86.65	226	63.47±11.07
Visit 2	204	8.90±9.19	44	127.93±48.39	35	218.37±85.59	81	180.75±86.59	189	64.03±11.03
Visit 3	236	8.42±6.16	48	141.56±62.96	46	192.37±66.21	68	199.68±84.45	180	64.94±11.21
Visit 3 (LOCF)	270	8.40±5.79	68	139.76±59.05	62	200.84±68.03	99	188.94±82.89	200	64.80±11.17
Visit 3 (LOCF) − Visit 1	270	−1.16±6.02	40	−54.9±90.89	35	−89.46±105.68	31	−40.65±115.72	197	1.45±3.64
p-value^a	0.0017		0.0005		<0.0001		0.0599		<0.0001

Notes: Visit 1=baseline, Visit 2=3 months, Visit 3=6 months. ^ap-value of paired t-test between Visit 1 and Visit 3 (LOCF) group.

Abbreviations: BW, body weight; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; LOCF, last observation carried forward; n, number of patients with non-missing values at the Visit; N, number of patients analyzed; PP2BG, postprandial blood glucose levels 2 hours after meal; PP2PG, postprandial plasma glucose levels 2 hours after meal; SD, standard deviation.

Table 3 Change in HbA1c and Body Weight Over 6 Months in the Intensive vs Non-Intensive Group

	Basal Insulin+1 Injection/Day Glulisine N=67		Basal Insulin+≥2 Injection/Day Glulisine N=87		Total (Basal Insulin+Glulisine) N=154		p-value
	n	Mean±SD	n	Mean±SD	n	Mean±SD
Change in HbA1c (%) over 6 months
Visit 1	67	9.40±1.41	87	9.23±2.17	154	9.30±1.88	0.5614^a
Visit 2	52	10.56±12.70	55	7.90±1.54	107	9.20±8.98	0.1279^b
Visit 3	58	8.67±1.54	81	7.91±1.39	139	8.23±1.50	0.0020^b
Visit 3 (LOCF)	67	8.76±1.53	87	7.82±1.40	154	8.23±1.53	<0.0001^b
Visit 3 (LOCF) − Visit 1	67	−0.64±1.47	87	−1.41±1.97	154	−1.07±1.81	<0.0001^b
Change in body weight (kg) over 6 months
Visit 1	54	62.31±10.18	64	65.56±11.19	118	64.08±10.81	0.1044^a
Visit 2	48	62.13±10.71	50	65.82±11.49	98	64.01±11.21	0.6542^b
Visit 3	49	64.65±11.28	49	66.35±10.42	98	65.50±10.84	0.4837^b
Visit 3 (LOCF)	52	64.38±11.34	53	66.15±11.07	105	65.28±11.19	0.5079^b
Visit 3 (LOCF) − Visit 1	49	1.51±4.43	53	0.87±3.2	102	1.18±3.83	0.5079^b

Notes: Visit 1=baseline, Visit 2=3 months, Visit 3=6 months. ^ap-value t-test, ^bp-value ANCOVA analysis.

Abbreviations: HbA1c, glycated hemoglobin; LOCF, last observation carried forward; n, number of patients with non-missing values at the Visit; N, number of patients analyzed; SD, standard deviation.