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 10, Number 8, August 2018, pages 648-656

Effect of Anagliptin on Glycemic and Lipid Profile in Patients With Type 2 Diabetes Mellitus

**Table 1.** Clinical and Laboratory Characteristics (Mean ± SD)
	Baseline
N	95
Age (years)	63.7 ± 11.7
Age ≥ 60	67 (70.5%)
Sex, M/F	59/36
Weight (kg)	66.3 ± 13.3
BMI (kg/m²)	25.4 ± 4.3
TC (mg/dL)	195.1 ± 41.6
LDL-C (mg/dL)	110.6 ± 37.1
HDL-C (mg/dL)	55.5 ± 13.8
TG (mg/dL)	148.1 ± 90.9
Glucose (mg/dL)	158.5 ± 41.0
HbA1c (NGSP) (%)	7.4 ± 0.7
Neuropathy	20 (21.0%)
Retinopathy	15 (15.8%)
Nephropathy	23 (24.2%)

Table 1. Clinical and Laboratory Characteristics (Mean ± SD)

Baseline

Age (years)

63.7 ± 11.7

Age ≥ 60

67 (70.5%)

Sex, M/F

59/36

Weight (kg)

66.3 ± 13.3

BMI (kg/m²)

25.4 ± 4.3

TC (mg/dL)

195.1 ± 41.6

LDL-C (mg/dL)

110.6 ± 37.1

HDL-C (mg/dL)

55.5 ± 13.8

TG (mg/dL)

148.1 ± 90.9

Glucose (mg/dL)

158.5 ± 41.0

HbA1c (NGSP) (%)

7.4 ± 0.7

Neuropathy

20 (21.0%)

Retinopathy

15 (15.8%)

Nephropathy

23 (24.2%)

**Table 2.** Clinical and Laboratory Characteristics Stratified by Gender (Mean ± SD)
	Female	Male	P-value
*P < 0.05.
N	36	59
Age (years)	63.3 ± 12.5	64.0 ± 11.3	0.77
Age ≥ 60	25 (69.4 %)	42 (71.2 %)
Weight (kg)	62.9 ± 11.5	68.4 ± 13.9	0.049*
BMI (kg/m²)	26.3 ± 4.3	24.9 ± 4.2	0.11
TC (mg/dL)	202.8 ± 43.7	190.1 ± 39.8	0.16
LDL-C (mg/dL)	114.5 ± 39.2	107.9 ± 35.7	0.42
HDL-C (mg/dL)	60.1 ±13.1	52.7 ± 13.5	0.010*
TG (mg/dL)	140.9 ± 67.2	152.6 ± 103.3	0.55
Glucose (mg/dL)	148.8 ± 29.7	164.3 ± 45.7	0.076
HbA1c (NGSP) (%)	7.5 ± 0.6	7.3 ±0.7	0.39
Cr (mg/dL)	0.66 ± 0.12	0.86 ± 0.14	< 0.001*
eGFR (mL/min/1.73m²)	72.3 ± 14.6	72.3 ± 13.7	1.00

Table 2. Clinical and Laboratory Characteristics Stratified by Gender (Mean ± SD)

Female

Male

P-value

*P < 0.05.

Age (years)

63.3 ± 12.5

64.0 ± 11.3

0.77

Age ≥ 60

25 (69.4 %)

42 (71.2 %)

Weight (kg)

62.9 ± 11.5

68.4 ± 13.9

0.049*

BMI (kg/m²)

26.3 ± 4.3

24.9 ± 4.2

0.11

TC (mg/dL)

202.8 ± 43.7

190.1 ± 39.8

0.16

LDL-C (mg/dL)

114.5 ± 39.2

107.9 ± 35.7

0.42

HDL-C (mg/dL)

60.1 ±13.1

52.7 ± 13.5

0.010*

TG (mg/dL)

140.9 ± 67.2

152.6 ± 103.3

0.55

Glucose (mg/dL)

148.8 ± 29.7

164.3 ± 45.7

0.076

HbA1c (NGSP) (%)

7.5 ± 0.6

7.3 ±0.7

0.39

Cr (mg/dL)

0.66 ± 0.12

0.86 ± 0.14

< 0.001*

eGFR (mL/min/1.73m²)

72.3 ± 14.6

72.3 ± 13.7

1.00

**Table 3.** Amount of Change and % Change From Baseline to 12 Weeks and 24 Weeks
	Baseline	12 weeks	24 weeks
*P < 0.05.
Weight (kg)	66.3 ± 13.3	66.1 ± 13.5	-1 (-1, -0.2)	-0.5 ± 1.8	0.016*	66.7 ± 13.8	0 (-1, 0.4)	-0.2 ± 2.3	0.35
TC (mg/dL)	195.1 ± 41.6	188.2 ± 38.3	-3 (-6, -0.1)	-7.6 ± 27.9	0.012*	189.4 ± 36.5	-3 (-5, -0.5)	-7.4 ± 22.1	0.0029*
LDL-C (mg/dL)	110.6 ± 37.1	105.4 ± 34.2	-2 (-7, 3.4)	-6.0 ± 28.7	0.06	104.7 ± 31.2	-3 (-7, 0.5)	-7.3 ± 19.6	0.0014*
HDL-C (mg/dL)	55.5 ± 13.8	55.2 ± 23.9	1 (-8, 11.3)	-0.4 ± 22.9	0.88	52.8 ± 14.0	-4 (-6, -1.4)	-2.5 ± 7.0	< 0.001*
TG (mg/dL)	148.1 ± 90.9	156.4 ± 110.8	13 (2, 23.5)	7.4 ± 80.5	0.38	171.6 ± 150.7	23 (3, 41.7)	21.1 ± 129.9	0.13
Glucose (mg/dL)	158.5 ± 41.0	144.4 ± 37.8	-6 (-11, -1.3)	-14.2 ± 40.9	0.0012*	140.9 ± 36.9	-7 (-13, -0.9)	-17.9 ± 52.0	0.0015*
HbA1c (%)	7.4 ± 0.7	7.0 ± 0.8	-5 (-6, -3)	-0.3 ± 0.6	< 0.001*	7.0 ± 0.9	-5 (-7, -2.8)	-0.4 ± 0.8	< 0.001*

Table 3. Amount of Change and % Change From Baseline to 12 Weeks and 24 Weeks

Baseline

12 weeks

24 weeks

Mean ± SD

% Change from baseline (mean (95% CL))

Amount of change (mean ± SD)

P-value

Mean ± SD

% Change from baseline (mean (95% CL))

Amount of change (mean ± SD)

P-value

*P < 0.05.

Weight (kg)

66.3 ± 13.3

66.1 ± 13.5

-1 (-1, -0.2)

-0.5 ± 1.8

0.016*

66.7 ± 13.8

0 (-1, 0.4)

-0.2 ± 2.3

0.35

TC (mg/dL)

195.1 ± 41.6

188.2 ± 38.3

-3 (-6, -0.1)

-7.6 ± 27.9

0.012*

189.4 ± 36.5

-3 (-5, -0.5)

-7.4 ± 22.1

0.0029*

LDL-C (mg/dL)

110.6 ± 37.1

105.4 ± 34.2

-2 (-7, 3.4)

-6.0 ± 28.7

0.06

104.7 ± 31.2

-3 (-7, 0.5)

-7.3 ± 19.6

0.0014*

HDL-C (mg/dL)

55.5 ± 13.8

55.2 ± 23.9

1 (-8, 11.3)

-0.4 ± 22.9

0.88

52.8 ± 14.0

-4 (-6, -1.4)

-2.5 ± 7.0

< 0.001*

TG (mg/dL)

148.1 ± 90.9

156.4 ± 110.8

13 (2, 23.5)

7.4 ± 80.5

0.38

171.6 ± 150.7

23 (3, 41.7)

21.1 ± 129.9

0.13

Glucose (mg/dL)

158.5 ± 41.0

144.4 ± 37.8

-6 (-11, -1.3)

-14.2 ± 40.9

0.0012*

140.9 ± 36.9

-7 (-13, -0.9)

-17.9 ± 52.0

0.0015*

HbA1c (%)

7.4 ± 0.7

7.0 ± 0.8

-5 (-6, -3)

-0.3 ± 0.6

< 0.001*

7.0 ± 0.9

-5 (-7, -2.8)

-0.4 ± 0.8

< 0.001*

**Table 4.** % Change From Baseline at 24 Weeks With Different Background
	N	TC	P-value	LDL-C	P-value	HDL-C	P-value	TG	P-value	Glucose	P-value	HbA1c	P-value
*P < 0.05.
Age
< 60	26	-2.9 ± 7.3	0.93	-5.5 ± 13.4	0.52	-6.3 ± 11.0	0.21	55.8 ± 134.3	0.1	-2.8 ± 33.7	0.45	-0.3 ± 10.3	0.01*
≥ 60	65	-2.7 ± 11.3		-2.9 ± 19.0		-2.9 ± 12.6		9.1 ± 62.9		-8.5 ± 26.2		-6.5 ± 8.7
Sex
Female	33	-5.2 ± 10.8	0.09	-7.6 ± 17.4	0.083	-3.1 ± 12.3	0.65	11.2 ± 64.9	0.32	-3.0 ± 22.5	0.30	-7.8 ± 8.0	0.013*
Male	58	-1.2 ± 9.8		-0.6 ± 17.6		-4.3 ± 12.3		29.2 ± 103.4		-9.0 ± 31.2		-3.0 ± 10.0
BMI
<25	44	-3.5 ± 10.7	0.53	-4.4 ± 15.8	0.63	-3.9 ± 11.3	0.97	13.6 ± 65.1	0.36	-8.1 ± 24.0	0.69	-5.6 ± 7.6	0.43
≥25 kg/m²	47	-2.1 ± 10.0		-2.4 ± 20.0		-3.9 ± 13.1		31.2 ± 110.7		-5.7 ± 32.3		-4.0 ± 11.1
Baseline
TC (< 200 mg/dL)	48	0.7 ± 9.7	< 0.001*	2.6 ± 18.2	< 0.001*	-1.1 ± 12.8	0.017*	15.0 ± 66.9	0.43	-8.1 ± 23.5	0.68	-6.1 ± 9.2	0.20
TC (≥ 200 mg/dL)	39	-7.1 ± 9.5		-12.0 ± 13.3		-7.3 ± 10.6		32.1 ± 118.6		-5.4 ± 34.1		-3.5 ± 9.7
LDL-C (< 120 mg/dL)	49	-0.8 ± 10.0	0.02*	1.4 ± 18.6	0.001*	-2.5 ± 12.7	0.17	10.3 ± 51.7	0.18	-5.4 ± 30.4	0.70	-5.0 ± 10.2	0.81
LDL-C (≥ 120 mg/dL)	35	-6.1 ± 10.1		-10.7 ± 13.7		-6.1 ± 11.2		42.3 ± 130.9		-7.9 ± 27.0		-4.5 ± 8.5
HDL-C (< 40 mg/dL)	11	3.7 ± 11.1	0.056	17.2 ± 26.4	0.063	6.3 ± 11.5	0.008*	5.5 ± 75.7	0.47	1.4 ± 41.1	0.48	-5.5 ± 16.7	0.87
HDL-C(≥ 40 mg/dL)	80	-3.7 ± 9.9		-5.5 ± 15.5		-5.3 ± 11.7		24.7 ± 93.1		-8.0 ± 26.4		-4.7 ± 8.3
TG (< 150 mg/dL)	55	-2.5 ± 10.1	0.74	-5.3 ± 14.3	0.3	-5.4 ± 13.0	0.18	36.3 ± 106.6	0.04*	-9.3 ± 27.9	0.32	-5.6 ± 10.0	0.25
TG (≥ 150 mg/dL)	35	-3.3 ± 11.0		-0.3 ± 22.7		-2.0 ± 10.7		1.0 ± 54.2		-3.0 ± 29.6		-3.2 ± 8.7
Lipid treatment
No	44	-4.6 ± 10.2	0.13	-7.1 ± 15.2	0.084	-4.0 ± 11.8	0.92	25.9 ± 105.5	0.74	-12.1 ± 24.6	0.084	-5.2 ± 10.8	0.69
Yes	47	-1.2 ± 10.3		-0.2 ± 19.4		-3.8 ± 12.7		19.4 ± 76.1		-1.8 ± 31.1		-4.4 ± 8.3
Statin
No	48	-3.2 ± 10.7	0.71	-6.6 ± 15.3	0.12	-3.8 ± 11.8	0.95	30.4 ± 105.9	0.38	-9.7 ± 30.2	0.31	-4.9 ± 11.5	0.88
Yes	43	-2.3 ± 10.0		-0.3 ± 19.7		-4.0 ± 12.9		13.7 ± 71.1		-3.6 ± 26.3		-4.6 ± 6.9

Table 4. % Change From Baseline at 24 Weeks With Different Background

P-value

LDL-C

P-value

HDL-C

P-value

Glucose

P-value

HbA1c

P-value

*P < 0.05.

Age

< 60

-2.9 ± 7.3

0.93

-5.5 ± 13.4

0.52

-6.3 ± 11.0

0.21

55.8 ± 134.3

0.1

-2.8 ± 33.7

0.45

-0.3 ± 10.3

0.01*

≥ 60

-2.7 ± 11.3

-2.9 ± 19.0

-2.9 ± 12.6

9.1 ± 62.9

-8.5 ± 26.2

-6.5 ± 8.7

Sex

Female

-5.2 ± 10.8

0.09

-7.6 ± 17.4

0.083

-3.1 ± 12.3

0.65

11.2 ± 64.9

0.32

-3.0 ± 22.5

0.30

-7.8 ± 8.0

0.013*

Male

-1.2 ± 9.8

-0.6 ± 17.6

-4.3 ± 12.3

29.2 ± 103.4

-9.0 ± 31.2

-3.0 ± 10.0

BMI

<25

-3.5 ± 10.7

0.53

-4.4 ± 15.8

0.63

-3.9 ± 11.3

0.97

13.6 ± 65.1

0.36

-8.1 ± 24.0

0.69

-5.6 ± 7.6

0.43

≥25 kg/m²

-2.1 ± 10.0

-2.4 ± 20.0

-3.9 ± 13.1

31.2 ± 110.7

-5.7 ± 32.3

-4.0 ± 11.1

Baseline

TC (< 200 mg/dL)

0.7 ± 9.7

< 0.001*

2.6 ± 18.2

< 0.001*

-1.1 ± 12.8

0.017*

15.0 ± 66.9

0.43

-8.1 ± 23.5

0.68

-6.1 ± 9.2

0.20

TC (≥ 200 mg/dL)

-7.1 ± 9.5

-12.0 ± 13.3

-7.3 ± 10.6

32.1 ± 118.6

-5.4 ± 34.1

-3.5 ± 9.7

LDL-C (< 120 mg/dL)

-0.8 ± 10.0

0.02*

1.4 ± 18.6

0.001*

-2.5 ± 12.7

0.17

10.3 ± 51.7

0.18

-5.4 ± 30.4

0.70

-5.0 ± 10.2

0.81

LDL-C (≥ 120 mg/dL)

-6.1 ± 10.1

-10.7 ± 13.7

-6.1 ± 11.2

42.3 ± 130.9

-7.9 ± 27.0

-4.5 ± 8.5

HDL-C (< 40 mg/dL)

3.7 ± 11.1

0.056

17.2 ± 26.4

0.063

6.3 ± 11.5

0.008*

5.5 ± 75.7

0.47

1.4 ± 41.1

0.48

-5.5 ± 16.7

0.87

HDL-C(≥ 40 mg/dL)

-3.7 ± 9.9

-5.5 ± 15.5

-5.3 ± 11.7

24.7 ± 93.1

-8.0 ± 26.4

-4.7 ± 8.3

TG (< 150 mg/dL)

-2.5 ± 10.1

0.74

-5.3 ± 14.3

0.3

-5.4 ± 13.0

0.18

36.3 ± 106.6

0.04*

-9.3 ± 27.9

0.32

-5.6 ± 10.0

0.25

TG (≥ 150 mg/dL)

-3.3 ± 11.0

-0.3 ± 22.7

-2.0 ± 10.7

1.0 ± 54.2

-3.0 ± 29.6

-3.2 ± 8.7

Lipid treatment

-4.6 ± 10.2

0.13

-7.1 ± 15.2

0.084

-4.0 ± 11.8

0.92

25.9 ± 105.5

0.74

-12.1 ± 24.6

0.084

-5.2 ± 10.8

0.69

Yes

-1.2 ± 10.3

-0.2 ± 19.4

-3.8 ± 12.7

19.4 ± 76.1

-1.8 ± 31.1

-4.4 ± 8.3

Statin

-3.2 ± 10.7

0.71

-6.6 ± 15.3

0.12

-3.8 ± 11.8

0.95

30.4 ± 105.9

0.38

-9.7 ± 30.2

0.31

-4.9 ± 11.5

0.88

Yes

-2.3 ± 10.0

-0.3 ± 19.7

-4.0 ± 12.9

13.7 ± 71.1

-3.6 ± 26.3

-4.6 ± 6.9

**Table 5.** Univariate and Multivariate Analysis
	Univariate	Multivariate
*P < 0.05.
% change in TC at 24 weeks
Age	≥ 60	0.2	(-4.8, 5.2)	0.94	-1.7	(-6.4, 3.0)	0.47
Sex	Male	4.0	(-0.4, 8.4)	0.075	3.9	(-0.1, 8.0)	0.055
BMI	≥ 25 kg/m²	1.4	(-2.9, 5.8)	0.52	2.4	(-1.9, 6.6)	0.27
Baseline TC	≥ 200 mg/dL	-7.9	(-11.9, -3.8)	< 0.001*	-10.1	(-15.7, -4.6)	< 0.001*
Baseline LDL-C	≥ 120 mg/dL	-5.3	(-9.7, -1.0)	0.016*	1.8	(-3.8, 7.4)	0.53
Baseline HDL-C	≥ 40 mg/dL	-7.4	(-13.8, -1.1)	0.021*	-3.7	(-10.5, 3.2)	0.29
Baseline TG	≥ 150 mg/dL	-0.8	(-5.4, 3.7)	0.73
Lipid therapy	Yes	3.4	(-0.9, 7.7)	0.12
Statin	Yes	0.8	(-3.5, 5.2)	0.71
% change in LDL-C at 24 weeks
Age	≥ 60	2.6	(-6.5, 11.7)	0.58	-1.2	(-9.3, 7.0)	0.78
Sex	Male	7.0	(-0.7, 14.8)	0.075	7.2	(0.3, 14.1)	0.04*
BMI	≥ 25 kg/m²	2.0	(-5.8, 9.8)	0.62	3.1	(-4.1, 10.3)	0.40
Baseline TC	≥ 200 mg/dL	-14.6	(-21.8, -7.4)	< 0.001*	-9.3	(-19.2, 0.6)	0.065
Baseline LDL-C	≥ 120 mg/dL	-12.1	(-19.5, -4.6)	0.002*	-3.9	(-13.7, 5.9)	0.44
Baseline HDL-C	≥ 40 mg/dL	-22.7	(-35.5, -10.0)	< 0.001*	-16.7	(-29.0, -4.4)	0.008*
Baseline TG	≥ 150 mg/dL	5.0	(-3.1, 13.0)	0.23
Lipid therapy	Yes	6.9	(-0.8, 14.5)	0.078
Statin	Yes	6.2	(-1.4, 13.9)	0.11
% change in HDL-C at 24 weeks
Age	≥ 60	3.4	(-2.1, 8.9)	0.22	-1.2	(-9.3, 7.0)	0.78
Sex	Male	-1.2	(-6.4, 4.0)	0.65	7.2	(0.3, 14.1)	0.04*
BMI	≥ 25 kg/m²	-0.1	(-5.1, 4.9)	0.97	3.1	(-4.1, 10.3)	0.40
Baseline TC	≥ 200 mg/dL	-6.1	(-11.1, -1.2)	0.015*	-9.3	(-19.2, 0.6)	0.065
Baseline LDL-C	≥ 120 mg/dL	-3.7	(-8.9, 1.5)	0.17	-3.9	(-13.7, 5.9)	0.44
Baseline HDL-C	≥ 40 mg/dL	-11.6	(-18.9, -4.3)	0.002*	-16.7	(-29, -4.4)	0.008*
Baseline TG	≥ 150 mg/dL	3.4	(-1.7, 8.5)	0.19
Lipid therapy	Yes	0.3	(-4.7, 5.3)	0.92
Statin	Yes	-0.2	(-5.2, 4.8)	0.95

Table 5. Univariate and Multivariate Analysis

Univariate

Multivariate

Regression coefficient (95% CI)

P-value

Regression coefficient (95% CI)

P-value

*P < 0.05.

% change in TC at 24 weeks

Age

≥ 60

0.2

(-4.8, 5.2)

0.94

-1.7

(-6.4, 3.0)

0.47

Sex

Male

4.0

(-0.4, 8.4)

0.075

3.9

(-0.1, 8.0)

0.055

BMI

≥ 25 kg/m²

1.4

(-2.9, 5.8)

0.52

2.4

(-1.9, 6.6)

0.27

Baseline TC

≥ 200 mg/dL

-7.9

(-11.9, -3.8)

< 0.001*

-10.1

(-15.7, -4.6)

< 0.001*

Baseline LDL-C

≥ 120 mg/dL

-5.3

(-9.7, -1.0)

0.016*

1.8

(-3.8, 7.4)

0.53

Baseline HDL-C

≥ 40 mg/dL

-7.4

(-13.8, -1.1)

0.021*

-3.7

(-10.5, 3.2)

0.29

Baseline TG

≥ 150 mg/dL

-0.8

(-5.4, 3.7)

0.73

Lipid therapy

Yes

3.4

(-0.9, 7.7)

0.12

Statin

Yes

0.8

(-3.5, 5.2)

0.71

% change in LDL-C at 24 weeks

Age

≥ 60

2.6

(-6.5, 11.7)

0.58

-1.2

(-9.3, 7.0)

0.78

Sex

Male

7.0

(-0.7, 14.8)

0.075

7.2

(0.3, 14.1)

0.04*

BMI

≥ 25 kg/m²

2.0

(-5.8, 9.8)

0.62

3.1

(-4.1, 10.3)

0.40

Baseline TC

≥ 200 mg/dL

-14.6

(-21.8, -7.4)

< 0.001*

-9.3

(-19.2, 0.6)

0.065

Baseline LDL-C

≥ 120 mg/dL

-12.1

(-19.5, -4.6)

0.002*

-3.9

(-13.7, 5.9)

0.44

Baseline HDL-C

≥ 40 mg/dL

-22.7

(-35.5, -10.0)

< 0.001*

-16.7

(-29.0, -4.4)

0.008*

Baseline TG

≥ 150 mg/dL

5.0

(-3.1, 13.0)

0.23

Lipid therapy

Yes

6.9

(-0.8, 14.5)

0.078

Statin

Yes

6.2

(-1.4, 13.9)

0.11

% change in HDL-C at 24 weeks

Age

≥ 60

3.4

(-2.1, 8.9)

0.22

-1.2

(-9.3, 7.0)

0.78

Sex

Male

-1.2

(-6.4, 4.0)

0.65

7.2

(0.3, 14.1)

0.04*

BMI

≥ 25 kg/m²

-0.1

(-5.1, 4.9)

0.97

3.1

(-4.1, 10.3)

0.40

Baseline TC

≥ 200 mg/dL

-6.1

(-11.1, -1.2)

0.015*

-9.3

(-19.2, 0.6)

0.065

Baseline LDL-C

≥ 120 mg/dL

-3.7

(-8.9, 1.5)

0.17

-3.9

(-13.7, 5.9)

0.44

Baseline HDL-C

≥ 40 mg/dL

-11.6

(-18.9, -4.3)

0.002*

-16.7

(-29, -4.4)

0.008*

Baseline TG

≥ 150 mg/dL

3.4

(-1.7, 8.5)

0.19

Lipid therapy

Yes

0.3

(-4.7, 5.3)

0.92

Statin

Yes

-0.2

(-5.2, 4.8)

0.95