Table 2.
Results of GLM model
| Vildagliptin | Glibenclamide | Treatment effect | Time effect | Interaction | |
|---|---|---|---|---|---|
| HBA1C (%) | |||||
| Baseline | 7.7 (7.4–7.9) | 7.7 (7.5–8.1) | p = 0.85 | p < 0.001 | p = 0.17 |
| 4 months | 6.8 (6.4–7.3) | 6.8 (6.4–7.3) | |||
| 12 months | 7.0 (6.5–7.3) | 7.1 (6.5–7.5) | |||
| FPG (mg/dl) | |||||
| Baseline | 155 ± 36 | 150 ± 30 | p = 0.80 | p < 0.001 | p = 0.64 |
| 4 months | 130 ± 36 | 129 ± 28 | |||
| 12 months | 129 ± 28 | 129 ± 30 | |||
| BMI (kg/m2) | |||||
| Baseline | 29 (27–33) | 29 (25–34) | p = 0.80 | p = 0.67 | p = 0.79 |
| 4 months | 29 (26–33) | 28 (26–33) | |||
| 12 months | 24 (26–33) | 29 (26–34) | |||
| eGFR (ml/min/1.73 m2) | |||||
| Baseline | 96.1 ± 11.8 | 96.0 ± 14.5 | p = 0.24 | p = 0.039 | p = 0.55 |
| 4 months | 95.8 ± 10.5 | 92.3 ± 14.7 | |||
| 12 months | 95.8 ± 12.0 | 92.5 ± 12.9 | |||
| EPC (n/106 events) | |||||
| Baseline | 39.0 (24.0–58.2) | 37.5 (25–59.8) | p = 0.025 | p = 0.008 | p = 0.58 |
| 4 months | 37.0 (27.0–65.0) | 36.0 (23.0–54.2) | |||
| 12 months | 45.0 (29.7–67) | 32.0 (22.2–53.5) | |||
| Circulating markers | |||||
| SDF-1α (pg/ml) | |||||
| Baseline | 2877 (2388–3713) | 3134 (2763–4117) | p < 0.001 | p = 0.38 | p = 0.035 |
| 4 months | 2293 (1585–3187) | 3100 (2572–3782) | |||
| 12 months | 2064 (1540–2954) | 3336 (2778–3863) | |||
| BNP (pg/ml) | |||||
| Baseline | 3 (1–9) | 3 (2–7) | p = 0.41 | p = 0.045 | p = 0.71 |
| 4 months | 3 (1–8) | 3 (1–5) | |||
| 12 months | 5 (3–12) | 6 (3–10) | |||
| IL-6 (pg/ml) | |||||
| Baseline | 4.7 (3.0–7.6) | 6.1 (4.2–9.2) | p = 0.93 | p = 0.77 | p = 0.15 |
| 4 months | 5.8 (3.7–9.7) | 5.4 (3.5–8.2) | |||
| 12 months | 5.0 (2.7–9.9) | 5.4 (3.7–6.7) | |||
| CRP (mg/l) | |||||
| Baseline | 4.0 (3.2–5.7) | 3.8 (2.6–6.3) | p = 0.43 | p = 0.51 | p = 0.79 |
| 4 months | 4.0 (2.7–5.5) | 3.2 (2.4–6.3) | |||
| 12 months | 3.6 (2.3–6.1) | 3.5 (2.9–3.9) | |||
| TNFα (pg/ml) | |||||
| Baseline | 1.4 (0.7–2.0) | 1.6 (1.1–2.4) | p = 0.24 | p = 0.25 | p = 0.97 |
| 4 months | 1.1 (0.5–1.8) | 1.7 (1.3–2.4) | |||
| 12 months | 1.1 (0.4–1.8) | 1.4 (0.8–2.2) | |||
| GLP-1 total (pM) | |||||
| Baseline | 84.0 (66.2–109.0) | 86.7 (73.7–97.0) | p = 0.75 | p = 0.83 | p = 0.91 |
| 4 months | |||||
| 12 months | 83.4 (68.8–107.0) | 88.5 (75.5–114.6) | |||
Data are reported as mean ± standard deviation or median (IQR)
Clinical variables, circulating markers and p values of GLM models (treatment, time and time × treatment effects)
GLM model for primary (EPC) and secondary (SDF-1α) endpoint was performed with adjustment for baseline levels
Statistically significant values (p < 0.05) are shown in italics