Comparison of efficacy and safety of two starting insulin regimens in non-Asian, Asian Indian, and East Asian patients with type 2 diabetes: a post hoc analysis of the PARADIGM study

Figures & data

Table 1 Baseline demographics and characteristics (full analysis set)

	Non-Asian		Asian Indian		East Asian
	LM25 (n=69)	G+L (n=61)	LM25 (n=53)	G+L (n=53)	LM25 (n=45)	G+L (n=44)
Mean age (SD), years	58.62 (8.67)	61.67 (8.45)	55.15 (8.22)	53.11 (8.62)	57.20 (7.62)	54.36 (9.07)
Female sex, n (%)	27 (39.1)	24 (39.3)	28 (52.8)	28 (52.8)	30 (66.7)	24 (54.5)
Mean duration of diabetes (SD), years	12.61 (6.52)	10.63 (6.32)	9.51 (6.88)	8.54 (4.41)	10.03 (5.02)	9.40 (4.43)
Mean body weight (SD), kg	84.03 (18.02)	82.12 (14.82)	65.96 (10.61)	67.90 (10.18)	67.79 (10.88)	65.69 (10.37)
Mean BMI (SD), kg/m^2	29.56 (4.02)	29.14 (3.82)	26.09 (3.54)	26.60 (3.87)	25.62 (3.15)	24.92 (2.81)
Mean HbA1c (SD), %	8.93 (1.02)	8.85 (1.01)	9.22 (1.09)	9.29 (1.00)	8.87 (0.92)	8.82 (1.08)
Sulfonylurea use, n (%)a	69 (100.0)	61 (100.0)	53 (100.0)	53 (100.0)	42 (93.3)	42 (95.5)

Note:

a At baseline, all patients in the full analysis set were on metformin.

Abbreviations: LM25, insulin lispro mix 25 (25% insulin lispro and 75% insulin lispro protamine suspension); G+L, glargine plus lispro; BMI, body mass index; HbA_1c, glycated hemoglobin.

Figure 1 LS mean change (SE of mean) in HbA_1c from baseline to the end point.

Abbreviations: LS, least-squares; SE, standard error; HbA_1c, glycated hemoglobin; LM25, insulin lispro mix 25 (25% insulin lispro and 75% insulin lispro protamine suspension); G+L, glargine plus lispro.

Figure 2 Percentage of patients achieving HbA_1c target <7% at the end point by race/ethnicity and by treatment arm.

Abbreviations: HbA_1c, glycated hemoglobin; LM25, insulin lispro mix 25 (25% insulin lispro and 75% insulin lispro protamine suspension); G+L, glargine plus lispro.

Table 2 Insulin dose/number of injections, weight change, and hypoglycemia rate

	Non-Asian		Asian Indian		East Asian
	LM25 (n=69)	G+L (n=61)	LM25 (n=53)	G+L (n=53)	LM25 (n=45)	G+L (n=44)
Mean daily insulin dose/kg (SD)	0.569 (0.370)	0.496 (0.366)	0.801 (0.500)	0.853 (0.681)	0.422 (0.371)	0.464 (0.368)
Total mean insulin dose (SD)	60.228 (34.156)	52.769 (39.924)	61.659 (33.559)	63.340 (33.723)	37.468 (17.255)	40.971 (26.297)
Basal insulin dose (SD)	45.171	36.596 (20.859)	46.244	36.340 (12.310)	28.101	23.371 (12.868)
Prandial insulin dose (SD)	15.057	16.173 (24.059)	15.415	27.000 (26.438)	9.367	17.600 (18.039)
Prandial dose/total dose (SD)		0.188 (0.232)		0.325 (0.254)		0.342 (0.273)
Mean number of injections	1.942	1.934	2.320	2.434	1.756	2.386
Number of injections
One, n (%)	16 (23.2)	36 (59)	13 (24.5)	17 (32)	19 (42.2)	19 (43.2)
Two, n (%)	41 (59.4)	7 (11.5)	10 (18.8)	5 (9.4)	18 (40.0)	2 (4.5)
Three, n (%)	12 (17.4)	4 (6.6)	30 (56.6)	22 (41.5)	8 (17.7)	10 (22.7)
Four, n (%)	–	14 (22.9)	–	9 (16.9)	–	13 (29.5)
Mean weight change (SD), kg	3.00 (4.09)	3.43 (4.72)	3.19 (3.87)	2.82 (3.42)	2.95 (2.97)	2.81 (3.39)
Hypoglycemia rate,a mean (SD)	3.292 (3.082)	2.992 (2.798)	1.110 (1.007)	1.482 (2.122)	1.266 (1.617)	0.857 (0.797)
Overall hypoglycemia, n (%)	64 (94.1)	56 (91.8)	47 (90.4)	46 (88.5)	30 (69.8)	34 (77.3)
Nocturnal hypoglycemia, n (%)	57 (83.8)	48 (78.7)	42 (80.8)	45 (86.5)	18 (41.9)	23 (52.3)
Severe hypoglycemia, n (%)	2 (2.9)	3 (4.9)	2 (3.9)	1 (1.9)	3 (7.0)	0 (0.0)

Note:

a Hypoglycemia rate was defined as event/patient/month.

Abbreviations: LM25, insulin lispro mix 25 (25% insulin and 75% insulin lispro protamine suspension); G+L, glargine plus lispro.

Table 3 Self-monitored blood glucose profile – actual measurements (mmol/L; excursion change from baseline)

			Baseline excursion before and after meal glucose difference, mean (SD)	End point (≥32 weeks) excursion before and after meal glucose difference, mean (SD)	Change in excursion between baseline and end point (≥32 weeks), mean (SD)
Breakfast	Non-Asian	LM25	3.735 (2.434)	1.855 (2.096)	−1.964 (2.637)
		G+L	3.969 (2.421)	2.680 (1.993)	−1.246 (2.795)
	Asian Indian	LM25	3.314 (2.567)	2.467 (1.435)	−0.741 (2.664)*
		G+L	3.347 (2.719)	2.795 (1.919)	−0.393 (2.634)
	East Asian	LM25	4.976 (2.456)	2.978 (2.042)	−2.323 (2.949)**
		G+L	5.174 (2.728)	2.872 (2.551)	−2.214 (3.252)**
Lunch	Non-Asian	LM25	1.240 (2.636)	2.030 (2.532)	0.918 (2.857)
		G+L	1.568 (2.244)	1.082 (2.116)	−0.274 (3.077)
	Asian Indian	LM25	2.923 (2.704)	2.517 (1.612)	−0.444 (3.148)*
		G+L	2.373 (3.296)	2.324 (1.773)	−0.062 (3.604)
	East Asian	LM25	3.614 (2.599)	3.130 (2.336)	−0.817 (3.185)***
		G+L	3.199 (2.964)	1.967 (1.77)	−0.928 (2.506)
Dinner	Non-Asian	LM25	1.681 (2.712)	0.854 (1.999)	−0.968 (2.708)
		G+L	2.038 (2.574)	1.496 (2.259)	−0.635 (3.358)
	Asian Indian	LM25	2.296 (2.912)	2.363 (1.654)	−0.173 (3.214)
		G+L	2.605 (2.785)	2.381 (1.930)	−0.192 (3.160)
	East Asian	LM25	3.177 (2.977)	1.588 (2.721)	−1.606 (3.224)
		G+L	2.517 (2.813)	1.371 (2.644)	−1.416 (3.479)

Notes:

* Significant (P<0.05) difference between Asian Indian and non-Asian.

** Significant (P<0.05) difference between East Asian and Asian Indian.

*** Significant (P<0.05) difference between East Asian and non-Asian.

Abbreviations: LM25, insulin lispro mix 25 (25% insulin and 75% insulin lispro protamine suspension); G+L, glargine plus lispro.