Starting glargine in insulin-naïve type 2 diabetic patients based on body mass index is safe

Table 1 Characteristics of the patient population, as grouped according to the four algorithms

	n	Gender	Age (yr)	Weight (kg)	BMI (kg/m2)	Duration (yr)	Baseline A1C	Baseline FPG (mg/dL)	Previous treatment
Fixed titration 2/2 U
LANMET	26	8 M	55.0 ± 10	78 ± 16.6	30.7 ± 4.95	8 ± 4.23	9.39% ± 1.67%	193.0 ± 59.4	2 OAD (20) 1 OAD (6)
Variable titration
LANMET PLUS	22	6 M	52.3 ± 7.7	70.6 ± 13	27.8 ± 4.7	7.8 ± 3.8	9.35% ± 1.34%	179.4 ± 51.4	2 OAD (21) 1 OAD (1)
Fixed titration 2/2 U
DeGold	23	14 M	54.6 ± 8	78.3 ± 13.5	28.8 ± 4.4	10.2 ± 7.1	9.21% ± 1.30%	196.6 ± 54.8	2 OAD (19) 1 OAD (4)
Variable titration
DeGold PLUS	21	12 M	53.8 ± 7.6	79.3 ± 15.9	29.5 ± 4.4	9.8 ± 5.4	9.61% ± 1.69%	196.1 ± 53.4	2 OAD (19) 1 OAD (2)

OAD: Oral anti-diabetes drug; FPG: Fasting plasma glucose; BMI: Body mass index.

Table 2 Treatment algorithms used in this study

Initial dose	BMI	Algorithms
		LANMET fixed	LANMETPlus	DeGold fixed	DeGoldPlus
Fixed initial dose in U	n.a.	10		10
Variable dose according to	< 26		0.2		0.2
BMI (kg/m2) in U/kg	26 < 30		0.25		0.25
	30 < 35		0.3		0.3
	> 35		0.35		0.35
Insulin adjustment	FPG
Fixed Titration twice/week in U		2	2
Variable titration according to	< 100			0	0
FPG (mg/dL) twice/week in U	101 < 120			-2	-2
	121 < 140			2	2
	141 < 180			4	4
	> 180			-2	-2

FPG: Fasting plasma glucose; BMI: Body mass index.

Table 3 Treatment efficacy data n (%)

	LANMET	LANMET PLUS	DeGold	DeGold PLUS
Initial insulin dose (U)	10.0 ± 0	10.0 ± 0	21.0 ± 7.3	18.3 ± 7.0
Initial insulin dose (U/kg)	0.13 ± 0.02	0.13 ± 0.03	0.26 ± 0.05	0.25 ± 0.05
Final insulin dose (U)	41.65 ± 14.00	87.00 ± 26.87	54.68 ± 21.63	48.19 ± 38.50
Final insulin dose (U/kg)	0.54 ± 0.20	0.59% ± 0.27%	0.67% ± 0.24%	0.65% ± 0.52%
Baseline A1C	9.39% ± 1.67%	9.35% ± 1.34%	9.21% ± 1.30%	9.61% ± 1.69%
Final A1C	7.36% ± 1.32%	7.32% ± 0.67%	6.82% ± 0.70%	7.38% ± 0.95%
Reduction in A1C	2.02% ± 1.60%	2.02% ± 1.17%	2.48% ± 1.23%	2.23% ± 1.69%
Proportion of patients reaching FPG target	19/26 (73)	16/20 (80)	22/23 (95)	20/21 (95)
Proportion of patients reaching A1C ≤ 7.5%	17/26 (65)	13/20 (65)	20/23 (87)	13/21 (62)
Proportion of patients reaching A1C ≤ 7.0%	11/26 (42)	5/20 (25)	16/23 (69)	7/21 (33)
Duration of titration to reach FPG target (d)	28 ± 31	15 ± 19	22 ± 20	20 ± 17
Weight variation (kg)	0.276 ± 2.94	1.190 ± 2.430	0.954 ± 2.590	1.630 ± 2.500
Final FPG (mg/dL)	119.4 ± 36.2	109.0 ± 28.7	106.6 ± 18.0	107.6 ± 17.3

FPG: Fasting plasma glucose.

Table 4 Hypoglycemia events n (%)

	LANMET	LANMETPLUS	DeGold	DeGoldPLUS	LANMET andLANMET PLUS	DeGold andDeGold PLUS	LANMETand DeGold	LANMET PLUSand DeGold PLUS
					Fixed initial dose	Variable initial dose	Fixed titration	Variable titration
Patients with moderate or severe hypoglycemia (n)	7 (27)	6 (30)	5 (22)	5 (23)	13 (28)	10 (23)	12 (25)	11 (27)
Number of moderate or severe hypoglycemia events	10	22	5	20	32	25	15	42
Patients with symptomatic night hypoglycemia (n)	13 (50)	4 (15)	5 (22)	4 (19)	17 (37)	9 (20)	18 (37)	8 (19)
Number of nocturnal symptomatic hypoglycemia events	46	16	9	8	62	17	31	25
Patients presenting any type of hypoglycemia (n)	16 (61)	14 (70)	15 (68)	12 (57)	30 (65)	27 (62)	31 (64)	26 (60)
Number of any type of hypoglycemia events	113	107	48	111	220	159	157	155