Abstract
Background
The effects of dipeptidyl peptidase-4 inhibitors on adipokines remain obscure. The aim of this study was to evaluate the effect of the addition of vildagliptin on visfatin, an adipokine that represents inflammatory biomarkers of adipose tissue, in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.
Methods
In this 16-week, double-blind, randomized, parallel-group, placebo-controlled study, 71 patients were randomly assigned to vildagliptin 50 mg twice a day (n = 35) or placebo (n = 36) added to ongoing metformin therapy. Fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), plasma lipids, and visfatin levels were measured at baseline and 16 weeks after treatment.
Results
After 16 weeks, significant reduction in HbA1c and FPG was observed with vildagliptin add-on treatment compared to placebo (‒0.54 ± 0.52%, P = 0.001 and ‒14.80 ± 19.21 mg/dL, P = 0.004, respectively). However, no other clinically meaningful changes in lipid parameters or visfatin were observed.
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Fig. 1.
Changes of plasma visfatin concentration after 16-weeks treatment. (A) Metformin + Placebo group, (B) Metformin + Vildagliptin group.
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Table 1.
Baseline demographic and clinical characteristic of the patients
Metformin + Vildagliptin (n = 35) | Metformin + Placebo (n = 36) | P-value | |
---|---|---|---|
Age (y) | 53.66 ± 10.94 | 52.53 ± 10.33 | 0.656a |
Sex | |||
Male | 21 (60.00) | 19 (52.80) | 0.540b |
Female | 14 (40.00) | 17 (47.20) | |
Weight (kg) Height (cm) | 68.78 ± 10.78 164.25 ± 8.68 | 67.19 ± 10.49 163.36 ± 8.10 | 0.530a 0.654a |
Waist circumference (cm) BMI (kg/m2) | 88.81 ± 8.01 25.39 ± 2.56 | 86.66 ± 15.34 25.05 ± 2.67 | 0.464a* 0.590a |
Duration of diabetes (y) | 11.18 ± 5.65 | 11.61 ± 5.93 | 0.755a |
HbA1c (%) | 7.35 ± 0.73 | 7.94 ± 1.06 | 0.008a |
FBS (mg/dL) | 134.00 ± 26.99 | 144.75 ± 36.83 | 0.166a |
SBP (mm Hg) | 127.46 ± 11.59 | 123.53 ± 12.65 | 0.177a |
DBP (mm Hg) | 75.60 ± 8.50 | 72.06 ± 8.03 | 0.075a |
Total cholesterol (mg/dL) | 166.54 ± 36.74 | 164.67 ± 33.73 | 0.823a |
Total cholesterol (mg/dL) LDL cholesterol (mg/dL) | 166.54 ± 36.74 96.26 ± 29.44 | 164.67 ± 33.73 97.17 ± 32.81 | 0.823 0.903a |
HDL cholesterol (mg/dL) | 43.86 ± 10.42 | 44.75 ± 10.25 | 0.717a |
HDL cholesterol (mg/dL) Triglyceride (mg/dL) | 43.86 ± 10.42 160.91 ± 98.21 | 44.75 ± 10.25 143.64 ± 96.77 | 0.717 0.458a |
Visfatin (ng/mL) | 2.68 ± 2.17 | 2.80 ± 2.63 | 0.834a |
Table 2.
Changes in efficacy from week 0(baseline) to week 16
Metformin + Placebo group | Metformin + Vildagliptin group | |||
---|---|---|---|---|
week 0 | week 16 | week 0 | week 16 | |
Weight (kg) | 67.17 ± 10.64 | 65.60 ± 11.46 c | 69.02 ± 10.85 | 68.35 ± 11.34 |
HbA1c (%) | 7.94 ± 1.06 | 8.14 ± 1.36 | 7.35 ± 0.73 | 6.81 ± 0.74 c |
FPG (mg/dL) | 144.75 ± 36.83 | 148.33 ± 43.75 | 134.00 ± 26.99 | 119.20 ± 24.48 cd |
Total cholesterol (mg/dL) | 164.67 ± 33.73 | 156.78 ± 33.74 | 166.54 ± 36.74 | 153.74 ± 30.12 a |
LDL (mg/dL) | 97.17 ± 32.81 | 88.28 ± 26.22 | 96.26 ± 29.44 | 82.17 ± 22.63 b |
HDL (mg/dL) | 44.75 ± 10.25 | 44.50 ± 12.45 | 43.86 ± 10.42 | 42.09 ± 9.93 a |
Triglyceride (mg/dL) | 143.64 ± 96.77 | 132.03 ± 79.96 | 160.91 ± 98.21 | 169.23 ± 100.08 |
Visfatin (ng/mL) | 2.80 ± 2.63 | 3.94 ± 3.13 | 2.68 ± 2.17 | 4.47 ± 3.20 b |
HOMA-IR (score) | 2.41 ± 1.90 | 2.16 ± 1.69 | 2.23 ± 1.93 | 2.05 ± 1.54 |
HOMA-β (%) | 38.13 ± 50.50 | 31.10 ± 24.36 | 33.51 ± 22.41 | 53.25 ± 58.85 ad |