J Endocrinol Metab

Journal of Endocrinology and Metabolism, ISSN 1923-2861 print, 1923-287X online, Open Access

Article copyright, the authors; Journal compilation copyright, J Endocrinol Metab and Elmer Press Inc

Journal website http://www.jofem.org

Original Article

Volume 9, Number 6, December 2019, pages 171-179

Long-Term Efficacy and Safety of Add-On Therapy of Sitagliptin to a Very Small Dose of Glimepiride Versus a Small Dose of Glimepiride Over Eighteen Months

Figure 2. FPG and HbA1c levels during the study in the SIT and SU groups. All data were presented as mean ± standard deviation (SD). *P < 0.05, **P < 0.01, ***P < 0.001 versus the basal value in each group. HbA1c: hemoglobin A1c; FPG: fasting plasma glucose.

Figure 3. PI/I ratio and HOMA-β during the study in the SIT and SU groups. All data were presented as mean ± standard deviation (SD). *P < 0.05 versus the basal value in each group. PI/I: proinsulin/insulin; HOMA-β: homeostasis model assessment-β cell.

**Table 1.** The Patients’ Basal Characteristics
	SIT group	SU group
BMI: body mass index; HbA1c: hemoglobin A1c; FPG: fasting plasma glucose; SBP: systolic blood pressure; DBP: diastolic blood pressure; LDL-C: low-density lipoprotein cholesterol; TG: triglycerides; HDL-C: high-density lipoprotein cholesterol.
Age (years)	65.8 ± 8.6	64.7 ± 6.9
Sex (%)	16 (53.3%)	17 (56.7%)
Body weight (kg)	63.1 ± 12.0	64.5 ± 9.4
BMI	24.0 ± 3.4	25.4 ± 3.3
Duration of diabetes mellitus
< 1 year	1 (3.3%)	1 (3.3%)
1 to < 5 years	5 (16.7%)	5 (16.7%)
5 to < 10 years	10 (33.3%)	5 (16.7%)
> 10 years	12 (40.0%)	15 (50.0%)
Not known	2 (6.7%)	4 (13.3%)
HbA1c (%)	7.8 ± 1.1	7.7 ± 0.6
FPG (mg/dL)	162.4 ± 39.9	153.2 ± 27.0
SBP (mm Hg)	127.2 ± 10.2	131.9 ± 16.8
DBP (mm Hg)	72.1 ± 9.6	76.0 ± 10.3
LDL-C (mg/dL)	111.4 ± 31.8	113.8 ± 23.5
TG (mg/dL)	142.4 ± 73.6	132.1 ± 77.5
HDL-C (mg/dL)	52.5 ± 13.3	52.5 ± 10.7
Smoking (%)	5 (16.7%)	1 (3.3%)
Drinking habit (%)	7 (23.3%)	7 (23.3%)
Comorbidities
Hypertension	17 (56.7%)	22 (73.3%)
Dyslipidemia	13 (43.3%)	13 (43.3%)
Hyperuricemia	2 (6.7%)	1 (3.3%)
Myocardial infarction	0 (0%)	1 (3.3%)
Angina pectoris	1 (3.3%)	0 (0)
Arteriosclerosis obliterans	0 (0%)	1 (3.3%)

Table 1. The Patients’ Basal Characteristics

SIT group

SU group

BMI: body mass index; HbA1c: hemoglobin A1c; FPG: fasting plasma glucose; SBP: systolic blood pressure; DBP: diastolic blood pressure; LDL-C: low-density lipoprotein cholesterol; TG: triglycerides; HDL-C: high-density lipoprotein cholesterol.

Age (years)

65.8 ± 8.6

64.7 ± 6.9

Sex (%)

16 (53.3%)

17 (56.7%)

Body weight (kg)

63.1 ± 12.0

64.5 ± 9.4

BMI

24.0 ± 3.4

25.4 ± 3.3

Duration of diabetes mellitus

< 1 year

1 (3.3%)

1 to < 5 years

5 (16.7%)

5 to < 10 years

10 (33.3%)

5 (16.7%)

> 10 years

12 (40.0%)

15 (50.0%)

Not known

2 (6.7%)

4 (13.3%)

HbA1c (%)

7.8 ± 1.1

7.7 ± 0.6

FPG (mg/dL)

162.4 ± 39.9

153.2 ± 27.0

SBP (mm Hg)

127.2 ± 10.2

131.9 ± 16.8

DBP (mm Hg)

72.1 ± 9.6

76.0 ± 10.3

LDL-C (mg/dL)

111.4 ± 31.8

113.8 ± 23.5

TG (mg/dL)

142.4 ± 73.6

132.1 ± 77.5

HDL-C (mg/dL)

52.5 ± 13.3

52.5 ± 10.7

Smoking (%)

5 (16.7%)

1 (3.3%)

Drinking habit (%)

7 (23.3%)

Comorbidities

Hypertension

17 (56.7%)

22 (73.3%)

Dyslipidemia

13 (43.3%)

Hyperuricemia

2 (6.7%)

1 (3.3%)

Myocardial infarction

0 (0%)

1 (3.3%)

Angina pectoris

1 (3.3%)

0 (0)

Arteriosclerosis obliterans

0 (0%)

1 (3.3%)

**Table 2.** Changes in Various Parameters During the Study in Two Groups
	SIT group	SU group
Mean ± standard deviation (SD). P < 0.05, P < 0.01, **P < 0.001 vs. 0 M. M: month; BMI: body mass index; FPG: fasting plasma glucose; HbA1c: hemoglobin A1c; CPR: C-peptide; PI/I: proinsulin/insulin; HOMA-β: homeostasis model assessment-β cell; HOMA-R: homeostasis model assessment for insulin resistance; SBP: systolic blood pressure; DBP: diastolic blood pressure; LDL-C: low-density lipoprotein cholesterol; TG: triglycerides; HDL-C: high-density lipoprotein cholesterol; eGFR: estimated glomerular filtration rate; UACR: urinary albumin/creatinine ratio. UACR (mg/gCr) has been log-transformed.
Body weight (kg)	63.1 ± 12.0	63.2 ± 12.0	63.8 ± 12.5	63.0 ± 12.0	62.8 ± 12.4	64.5 ± 9.4	64.8 ± 9.0	64.9 ± 9.2	64.7 ± 9.3	64.9 ± 8.9
BMI	24.0 ± 3.4	24.0 ± 3.4	24.3 ± 3.6	23.9 ± 3.4	23.9 ± 3.5	25.4 ± 3.3	25.4 ± 3.3	25.5 ± 3.4	25.5 ± 3.6	25.6 ± 3.6
FPG (mg/dL)	162.4 ± 39.9	147.6 ± 37.8	153.9 ± 45.5	149.9 ± 37.4	143.1 ± 31.2	153.2 ± 27.0	153.2 ± 27.0	147.9 ± 35.9	147.7 ± 28.0	155.6 ± 34.6
HbA1c (%)	7.8 ± 1.1	7.1 ± 1.0***	7.2 ± 1.2**	7.3 ± 1.4**	7.1 ± 0.6**	7.7 ± 0.6	7.4 ± 0.9*	7.4 ± 1.0*	7.3 ± 0.9*	7.2 ± 0.8**
Insulin (µU/mL)	8.2 ± 3.9	9.4 ± 4.7	9.6 ± 5.1	9.9 ± 6.4	10.4 ± 6.7	8.8 ± 10.0	11.5 ± 11.7	10.1 ± 8.4	10.7 ± 10.3	10.3 ± 9.2
CPR (ng/mL)	2.1 ± 0.5	2.4 ± 0.8	2.4 ± 0.8	2.3 ± 0.7	2.3 ± 0.8	2.2 ± 1.1	2.4 ± 1.4	2.3 ± 1.0	2.3 ± 1.0	2.3 ± 1.0
Proinsulin (pmol/L)	28.6 ± 16.6	30.1 ± 14.3	31.6 ± 16.8	30.8 ± 20.4	29.7 ± 19.5	25.6 ± 11.0	30.8 ± 16.2	26.4 ± 10.2	25.1 ± 11.4	21.9 ± 11.2
PI/I	0.62 ± 0.51	0.63 ± 0.36	0.56 ± 0.34	0.57 ± 0.40	0.52 ± 0.28	0.82 ± 0.66	0.60 ± 0.29	0.54 ± 0.27*	0.48 ± 0.29*	0.44 ± 0.26*
HOMA-β	53.2 ± 46.7	64.7 ± 50.4	69.6 ± 58.6*	64.3 ± 46.7	72.6 ± 54.9*	39.4 ± 26.0	81.2 ± 82.1	69.7 ± 49.5*	59.7 ± 46.5	56.6 ± 40.9
HOMA-R	3.0 ± 1.4	3.0 ± 1.2	3.5 ± 1.9	3.1 ± 1.5	3.3 ± 1.7	3.1 ± 2.8	3.8 ± 3.6	3.7 ± 3.1	3.7 ± 3.3	3.6 ± 2.8
SBP (mm Hg)	127.2 ± 10.2	125.9 ± 10.3	126.9 ± 15.1	123.6 ± 13.1	126.2 ± 14.4	131.9 ± 16.8	131.8 ± 17.5	132.9 ± 17.2	129.9 ± 14.6	130.4 ± 15.0
DBP (mm Hg)	72.1 ± 9.6	72.0 ± 9.6	72.2 ± 9.4	67.9 ± 9.9	70.4 ± 9.0	76.0 ± 10.3	75.6 ± 14.0	76.8 ± 10.7	74.9 ± 9.9	73.3 ± 8.5
LDL-C (mg/dL)	111.4 ± 31.8	112.5 ± 35.4	113.8 ± 32.2	116.4 ± 37.1	110.5 ± 34.7	113.8 ± 23.5	113.8 ± 23.5	114.0 ± 34.6	119.5 ± 29.7	107.3 ± 6.4
TG (mg/dL)	142.4 ± 73.6	142.4 ± 73.6	136.1 ± 63.1	135.9 ± 58.3	140.9 ± 66.2	132.1 ± 77.5	126.4 ± 75.3	131.2 ± 68.3	164.5 ± 221.4	139.4 ± 78.0
HDL-C (mg/dL)	52.5 ± 13.3	49.2 ± 12.2	50.4 ± 12.3	49.6 ± 13.0	50.0 ± 13.4	52.5 ± 10.7	51.9 ± 12.1	52.1 ± 11.4	51.9 ± 10.6	52.9 ± 10.8
eGFR (mL/min/1.73 m²)	79.2 ± 19.9	76.9 ± 18.7	78.8 ± 22.8	74.2 ± 18.4*	72.7 ± 19.5*	80.8 ± 22.2	79.8 ± 22.0	81.6 ± 22.2	80.5 ± 24.3	76.6 ± 20.4
log UACR	1.46 ± 0.7	1.31 ± 0.7	1.40 ± 0.7	1.35 ± 0.6	1.36 ± 0.7	1.34 ± 0.4	1.42 ± 0.5	1.57 ± 0.5	1.55 ± 0.5	1.48 ± 0.4

Table 2. Changes in Various Parameters During the Study in Two Groups

SIT group

SU group

0 M

3 M

6 M

12 M

18 M

0 M

3 M

6 M

12 M

18 M

Mean ± standard deviation (SD). *P < 0.05, **P < 0.01, ***P < 0.001 vs. 0 M. M: month; BMI: body mass index; FPG: fasting plasma glucose; HbA1c: hemoglobin A1c; CPR: C-peptide; PI/I: proinsulin/insulin; HOMA-β: homeostasis model assessment-β cell; HOMA-R: homeostasis model assessment for insulin resistance; SBP: systolic blood pressure; DBP: diastolic blood pressure; LDL-C: low-density lipoprotein cholesterol; TG: triglycerides; HDL-C: high-density lipoprotein cholesterol; eGFR: estimated glomerular filtration rate; UACR: urinary albumin/creatinine ratio. UACR (mg/gCr) has been log-transformed.

Body weight (kg)

63.1 ± 12.0

63.2 ± 12.0

63.8 ± 12.5

63.0 ± 12.0

62.8 ± 12.4

64.5 ± 9.4

64.8 ± 9.0

64.9 ± 9.2

64.7 ± 9.3

64.9 ± 8.9

BMI

24.0 ± 3.4

24.3 ± 3.6

23.9 ± 3.4

23.9 ± 3.5

25.4 ± 3.3

25.5 ± 3.4

25.5 ± 3.6

25.6 ± 3.6

FPG (mg/dL)

162.4 ± 39.9

147.6 ± 37.8

153.9 ± 45.5

149.9 ± 37.4

143.1 ± 31.2

153.2 ± 27.0

147.9 ± 35.9

147.7 ± 28.0

155.6 ± 34.6

HbA1c (%)

7.8 ± 1.1

7.1 ± 1.0***

7.2 ± 1.2**

7.3 ± 1.4**

7.1 ± 0.6**

7.7 ± 0.6

7.4 ± 0.9*

7.4 ± 1.0*

7.3 ± 0.9*

7.2 ± 0.8**

Insulin (µU/mL)

8.2 ± 3.9

9.4 ± 4.7

9.6 ± 5.1

9.9 ± 6.4

10.4 ± 6.7

8.8 ± 10.0

11.5 ± 11.7

10.1 ± 8.4

10.7 ± 10.3

10.3 ± 9.2

CPR (ng/mL)

2.1 ± 0.5

2.4 ± 0.8

2.3 ± 0.7

2.3 ± 0.8

2.2 ± 1.1

2.4 ± 1.4

2.3 ± 1.0

Proinsulin (pmol/L)

28.6 ± 16.6

30.1 ± 14.3

31.6 ± 16.8

30.8 ± 20.4

29.7 ± 19.5

25.6 ± 11.0

30.8 ± 16.2

26.4 ± 10.2

25.1 ± 11.4

21.9 ± 11.2

PI/I

0.62 ± 0.51

0.63 ± 0.36

0.56 ± 0.34

0.57 ± 0.40

0.52 ± 0.28

0.82 ± 0.66

0.60 ± 0.29

0.54 ± 0.27*

0.48 ± 0.29*

0.44 ± 0.26*

HOMA-β

53.2 ± 46.7

64.7 ± 50.4

69.6 ± 58.6*

64.3 ± 46.7

72.6 ± 54.9*

39.4 ± 26.0

81.2 ± 82.1

69.7 ± 49.5*

59.7 ± 46.5

56.6 ± 40.9

HOMA-R

3.0 ± 1.4

3.0 ± 1.2

3.5 ± 1.9

3.1 ± 1.5

3.3 ± 1.7

3.1 ± 2.8

3.8 ± 3.6

3.7 ± 3.1

3.7 ± 3.3

3.6 ± 2.8

SBP (mm Hg)

127.2 ± 10.2

125.9 ± 10.3

126.9 ± 15.1

123.6 ± 13.1

126.2 ± 14.4

131.9 ± 16.8

131.8 ± 17.5

132.9 ± 17.2

129.9 ± 14.6

130.4 ± 15.0

DBP (mm Hg)

72.1 ± 9.6

72.0 ± 9.6

72.2 ± 9.4

67.9 ± 9.9

70.4 ± 9.0

76.0 ± 10.3

75.6 ± 14.0

76.8 ± 10.7

74.9 ± 9.9

73.3 ± 8.5

LDL-C (mg/dL)

111.4 ± 31.8

112.5 ± 35.4

113.8 ± 32.2

116.4 ± 37.1

110.5 ± 34.7

113.8 ± 23.5

114.0 ± 34.6

119.5 ± 29.7

107.3 ± 6.4

TG (mg/dL)

142.4 ± 73.6

136.1 ± 63.1

135.9 ± 58.3

140.9 ± 66.2

132.1 ± 77.5

126.4 ± 75.3

131.2 ± 68.3

164.5 ± 221.4

139.4 ± 78.0

HDL-C (mg/dL)

52.5 ± 13.3

49.2 ± 12.2

50.4 ± 12.3

49.6 ± 13.0

50.0 ± 13.4

52.5 ± 10.7

51.9 ± 12.1

52.1 ± 11.4

51.9 ± 10.6

52.9 ± 10.8

eGFR (mL/min/1.73 m²)

79.2 ± 19.9

76.9 ± 18.7

78.8 ± 22.8

74.2 ± 18.4*

72.7 ± 19.5*

80.8 ± 22.2

79.8 ± 22.0

81.6 ± 22.2

80.5 ± 24.3

76.6 ± 20.4

log UACR

1.46 ± 0.7

1.31 ± 0.7

1.40 ± 0.7

1.35 ± 0.6

1.36 ± 0.7

1.34 ± 0.4

1.42 ± 0.5

1.57 ± 0.5

1.55 ± 0.5

1.48 ± 0.4