J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 6, Number 2, April 2014, pages 138-144

Is a Switch From Insulin Therapy to Liraglutide Possible in Japanese Type 2 Diabetes Mellitus Patients?/b>

Figure 1. ROC curve analyses to identify predictors of continuing lira therapy. ROC curves of duration and total insulin dose before start of liraglutide therapy as covariates in the prediction of 6-month continuation of lira therapy are shown. The higher the area under the curve (namely, the greater the curvature away from the 50% line (zero prediction)), the greater the predictive power.

**Table 1.** Characteristics of the Enrolled Population and Subject Disposition
	Liraglutide continuation group	Liraglutide discontinuation group	P value
Data are means ± SD or n (%), N (number) unless otherwise noted. SBP: systolic blood pressure; DBP: diastolic blood pressure; Cr: creatinine; TC: total cholesterol; LDL: low-density lipoprotein; HDL: high-density lipoprotein; TG: triglycerides; BMI: body mass index; BW: body weight; BOT: basal oral therapy; OAD: oral antidiabetic agents; SU: sulfonylurea; BG: biguanide; TZD: thiazolidine; αGI: α-glucosidase inhibitor.
Sex: male/female (%)	58/42	62/38	P > 0.05
Age (years)	60 ± 11	60 ± 11	P > 0.05
Duration of diabetes (years)	11 ± 8	14 ± 9	P < 0.01
SBP (mmHg)	128 ± 17	124 ± 14	P > 0.05
DBP (mmHg)	74 ± 12	72 ± 11	P > 0.05
Cr (mg/dL)	0.82 ± 0.31	0.85 ± 0.31	P > 0.05
TC (mg/dL)	183 ± 31	191 ± 33	P > 0.05
LDL (mg/dL)	107 ± 29	104 ± 29	P > 0.05
HDL (mg/dL)	54 ± 13	55 ± 19	P > 0.05
TG (mg/dL)	147 ± 82	175 ± 184	P > 0.05
BMI (kg/m²)	26.1 ± 4.9	26.8 ± 5.0	P > 0.05
ΔBW (0 - 12 weeks)	-1.6 ± 2.8	-0.8 ± 2.9	P < 0.001
HbA1c (%, mmol/mol)	7.3 ± 1.2, 56 ± 13.1	8.0 ± 1.4, 64 ± 15.3	P < 0.01
ΔHbA1c (0 - 12 weeks) (%, mmol/mol)	-0.4 ± 0.3, -4.4 ± 3.3	0.6 ± 0.9, 6.6 ± 9.8	P < 0.001
Insulin therapy (BOT/Premix/Basal bolus) (%)	27/13/60	20/6/74	P > 0.05
Total insulin dose (U/day)	18 ± 15	29 ± 17	P < 0.001
Prestudy OAD treatment (n)
SU/BG/TZD/αGI/glinide/none	28/24/15/27/14/96	11/13/6/7/3/46	P > 0.05

Table 1. Characteristics of the Enrolled Population and Subject Disposition

Liraglutide continuation group

Liraglutide discontinuation group

P value

n = 161

n = 70

Data are means ± SD or n (%), N (number) unless otherwise noted. SBP: systolic blood pressure; DBP: diastolic blood pressure; Cr: creatinine; TC: total cholesterol; LDL: low-density lipoprotein; HDL: high-density lipoprotein; TG: triglycerides; BMI: body mass index; BW: body weight; BOT: basal oral therapy; OAD: oral antidiabetic agents; SU: sulfonylurea; BG: biguanide; TZD: thiazolidine; αGI: α-glucosidase inhibitor.

Sex: male/female (%)

58/42

62/38

P > 0.05

Age (years)

60 ± 11

P > 0.05

Duration of diabetes (years)

11 ± 8

14 ± 9

P < 0.01

SBP (mmHg)

128 ± 17

124 ± 14

P > 0.05

DBP (mmHg)

74 ± 12

72 ± 11

P > 0.05

Cr (mg/dL)

0.82 ± 0.31

0.85 ± 0.31

P > 0.05

TC (mg/dL)

183 ± 31

191 ± 33

P > 0.05

LDL (mg/dL)

107 ± 29

104 ± 29

P > 0.05

HDL (mg/dL)

54 ± 13

55 ± 19

P > 0.05

TG (mg/dL)

147 ± 82

175 ± 184

P > 0.05

BMI (kg/m²)

26.1 ± 4.9

26.8 ± 5.0

P > 0.05

ΔBW (0 - 12 weeks)

-1.6 ± 2.8

-0.8 ± 2.9

P < 0.001

HbA1c (%, mmol/mol)

7.3 ± 1.2, 56 ± 13.1

8.0 ± 1.4, 64 ± 15.3

P < 0.01

ΔHbA1c (0 - 12 weeks) (%, mmol/mol)

-0.4 ± 0.3, -4.4 ± 3.3

0.6 ± 0.9, 6.6 ± 9.8

P < 0.001

Insulin therapy (BOT/Premix/Basal bolus) (%)

27/13/60

20/6/74

P > 0.05

Total insulin dose (U/day)

18 ± 15

29 ± 17

P < 0.001

Prestudy OAD treatment (n)

SU/BG/TZD/αGI/glinide/none

28/24/15/27/14/96

11/13/6/7/3/46

P > 0.05

**Table 2.** Predictors of ΔHbA1c and ΔBW in the Liraglutide Therapy Groups on Multiple Regression Analysis
	Predictors of ΔHbA1c 0 - 12 weeks	Predictors of ΔBW 0 - 12 weeks
BMI, body mass index.
Age	-0.034	0.665	-0.102	0.190
Sex	-0.062	0.396	0.061	0.425
Duration	-0.015	0.839	-0.024	0.749
BMI	0.032	0.704	-0.052	0.539
Basal HbA1c	-0.201	< 0.01	-0.084	0.339
Total insulin dose	0.018	< 0.001	-0.068	< 0.001

Table 2. Predictors of ΔHbA1c and ΔBW in the Liraglutide Therapy Groups on Multiple Regression Analysis

Predictors of ΔHbA1c 0 - 12 weeks

Predictors of ΔBW 0 - 12 weeks

BMI, body mass index.

Age

-0.034

0.665

-0.102

0.190

Sex

-0.062

0.396

0.061

0.425

Duration

-0.015

0.839

-0.024

0.749

BMI

0.032

0.704

-0.052

0.539

Basal HbA1c

-0.201

< 0.01

-0.084

0.339

Total insulin dose

0.018

< 0.001

-0.068

< 0.001

**Table 3.** Logistic Regression Analysis With Advisability of Continuing Liraglutide Therapy to 6 Months as the Dependent Variable
	OR	95% CI	P value
Duration	1.04	1.005 to 1.076	0.024
Total insulin dose	1.04	1.016 to 1.056	< 0.001

Table 3. Logistic Regression Analysis With Advisability of Continuing Liraglutide Therapy to 6 Months as the Dependent Variable

95% CI

P value

Duration

1.04

1.005 to 1.076

0.024

Total insulin dose

1.04

1.016 to 1.056

< 0.001