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 9, Number 3, March 2017, pages 193-199

Efficacy and Safety of Vildagliptin as an Add-On Therapy in Inadequately Controlled Type 2 Diabetes Patients Treated With Basal Insulin

Figure 1. Flow diagram of patient recruitment. Twenty-four patients were randomly allocated to either the control group or the vildagliptin group. All patients were followed up for 6 months.

Figure 2. HbA1c levels during the study period in the control and vildagliptin groups. *P < 0.01, ^#P < 0.05, compared with the control group.

Figure 3. Blood glucose profile in the control and vildagliptin groups measured before (0 M) and after 6 months (6 M). 0 and 2: blood glucose level before and 2 h after the indicated meal. Vildagliptin significantly improved blood glucose levels 2 h after breakfast and dinner, and blood glucose levels before dinner compared with the baseline. ^#P < 0.05, compared with the baseline.

**Table 1.** Characteristics of Subjects at Baseline
	Control	Vildagliptin	P-value
Data are mean ± SD or median (interquartile range). BMI: body mass index; HDL-C: high-density lipoprotein cholesterol; UAE: urinary albumin excretion; 1,5-AG: 1,5-anhydroglucitol.
n	12	12
Gender (males/females)	8/4	11/1
Age (years)	61.7 ± 10.0	60.0 ± 11.4	0.688
BMI (kg/m²)	24.8 ± 5.3	25.6 ± 5.4	0.719
Systolic blood pressure (mm Hg)	132.3 ± 17.7	134.2 ± 17.4	0.816
Diastolic blood pressure (mm Hg)	72.3 ± 13.1	80.1 ± 11.5	0.183
Diabetes duration (years)	10.5 ± 9.1	14.2 ± 8.8	0.327
HbA1c (%)	7.7 ± 0.6	8.1 ± 0.7	0.172
1,5-AG (μg/mL)	6.4 ± 3.4	4.4 ± 3.3	0.183
Fasting blood glucose (mg/dL)	133.1 ± 32.3	144.1 ± 30.1	0.397
C-peptide (ng/mL)	2.7 ± 2.5	1.9 ± 1.1	0.385
C-peptide index	1.89 ± 1.46	1.38 ± 0.76	0.337
Total cholesterol (mg/dL)	194.3 ± 35.8	163.9 ± 26.8	0.056
HDL-C (mg/dL)	54.9 ± 21.7	44.0 ± 12.4	0.158
Triglyceride (mg/dL)	121.2 ± 59.9	120.6 ± 42.2	0.978
UAE (mg/gCre)	9.8 (3.7 - 78.0)	18.8 (12.0 - 21.8)	0.449
Medications for diabetes
Oral anti-diabetes therapy
Sulfonyl urea (n)	6	6
Metformin (n)	9	9
α-GI inhibitor (n)	3	1
Thiazolidine (n)	1	2
Glinide (n)	0	1
Insulin dose (units)	9.4 ± 2.3	10.4 ± 6.4	0.619
Insulin type
Detemir	1	2
Glargine	8	8
Degludec	3	2

Table 1. Characteristics of Subjects at Baseline

Control

Vildagliptin

P-value

Data are mean ± SD or median (interquartile range). BMI: body mass index; HDL-C: high-density lipoprotein cholesterol; UAE: urinary albumin excretion; 1,5-AG: 1,5-anhydroglucitol.

Gender (males/females)

8/4

11/1

Age (years)

61.7 ± 10.0

60.0 ± 11.4

0.688

BMI (kg/m²)

24.8 ± 5.3

25.6 ± 5.4

0.719

Systolic blood pressure (mm Hg)

132.3 ± 17.7

134.2 ± 17.4

0.816

Diastolic blood pressure (mm Hg)

72.3 ± 13.1

80.1 ± 11.5

0.183

Diabetes duration (years)

10.5 ± 9.1

14.2 ± 8.8

0.327

HbA1c (%)

7.7 ± 0.6

8.1 ± 0.7

0.172

1,5-AG (μg/mL)

6.4 ± 3.4

4.4 ± 3.3

0.183

Fasting blood glucose (mg/dL)

133.1 ± 32.3

144.1 ± 30.1

0.397

C-peptide (ng/mL)

2.7 ± 2.5

1.9 ± 1.1

0.385

C-peptide index

1.89 ± 1.46

1.38 ± 0.76

0.337

Total cholesterol (mg/dL)

194.3 ± 35.8

163.9 ± 26.8

0.056

HDL-C (mg/dL)

54.9 ± 21.7

44.0 ± 12.4

0.158

Triglyceride (mg/dL)

121.2 ± 59.9

120.6 ± 42.2

0.978

UAE (mg/gCre)

9.8 (3.7 - 78.0)

18.8 (12.0 - 21.8)

0.449

Medications for diabetes

Oral anti-diabetes therapy

Sulfonyl urea (n)

Metformin (n)

α-GI inhibitor (n)

Thiazolidine (n)

Glinide (n)

Insulin dose (units)

9.4 ± 2.3

10.4 ± 6.4

0.619

Insulin type

Detemir

Glargine

Degludec

**Table 2.** Changes in Clinical Parameters Relative to the Baseline
	Control	Vildagliptin	P-value
Data are mean ± SD or median (interquartile range). BMI: body mass index; HDL-C: high-density lipoprotein cholesterol; UAE: urinary albumin excretion; 1,5-AG: 1,5-anhydroglucitol.
BMI (kg/m²)	0.13 ± 0.44	0.51 ± 0.81	0.183
Fasting blood glucose (mg/dL)	6.5 ± 24.6	-6.3 ± 43.6	0.400
C-peptide index (ng/mL)	-0.14 ± 1.09	0.83 ± 1.54	0.107
UAE (mg/gCre)	3.95 (-18.5 - 10.8)	0.4 (-6.4 - 5.1)	0.722
Insulin unit (unit/day)	1.0 ± 2.2	2.5 ± 2.2	0.130
HbA1c (%)	-1.0 ± 0.3	0.2 ± 0.8	< 0.01
1,5-AG (μg/mL)	4.5 ± 3.4	0.5 ± 4.1	0.03

Table 2. Changes in Clinical Parameters Relative to the Baseline

Control

Vildagliptin

P-value

Data are mean ± SD or median (interquartile range). BMI: body mass index; HDL-C: high-density lipoprotein cholesterol; UAE: urinary albumin excretion; 1,5-AG: 1,5-anhydroglucitol.

BMI (kg/m²)

0.13 ± 0.44

0.51 ± 0.81

0.183

Fasting blood glucose (mg/dL)

6.5 ± 24.6

-6.3 ± 43.6

0.400

C-peptide index (ng/mL)

-0.14 ± 1.09

0.83 ± 1.54

0.107

UAE (mg/gCre)

3.95 (-18.5 - 10.8)

0.4 (-6.4 - 5.1)

0.722

Insulin unit (unit/day)

1.0 ± 2.2

2.5 ± 2.2

0.130

HbA1c (%)

-1.0 ± 0.3

0.2 ± 0.8

< 0.01

1,5-AG (μg/mL)

4.5 ± 3.4

0.5 ± 4.1

0.03