TABLE 4.
Changes in Biomarkers from Baseline to Week 6/8
| Variable | Mean change (baseline) | |||||||||||
| Normoglycemic subgroup | Prediabetes mellitus subgroup | T2DM subgroup | ||||||||||
| Pool A | Placebo | AZL-M 40 mg | AZL-M 80 mg | OLM 40 mg | Placebo | AZL-M 40 mg | AZL-M 80 mg | OLM 40 mg | Placebo | AZL-M 40 mg | AZL-M 80 mg | OLM 40 mg |
| N | 41–95 | 92–171 | 106–200 | 92–198 | 68–113 | 114–190 | 120–181 | 128–200 | 27–42 | 67–113 | 50–95 | 54–83 |
| FPG (mmol/l) | −0.0 (5.3) | +0.0 (5.3) | −0.1 (5.3)† | +0.1 (5.3) | +0.0 (5.6) | +0.0 (5.7) | +0.0 (5.6) | −0.0 (5.5) | +0.5 (7.3) | +0.1 (6.9) | −0.2 (6.9)*,† | +0.4 (7.1) |
| Free insulin (μIU/ml) | −3.1 (9.6) | −0.9 (14) | −2.2 (13)† | +1.8 (13) | −1.0 (15) | +0.3 (13) | +1.8 (15) | −1.2 (13) | +1.8 (13) | +1.5 (19) | +2.7 (16) | −3.2 (20) |
| HOMA | −1.1 (2.4) | −0.2 (3.8) | −0.8 (3.3)† | +0.4 (3.6)* | −0.1 (3.9) | +0.0 (3.6) | +0.7 (4.2) | −0.4 (3.6) | +1.0 (4.3) | +0.8 (5.9) | +1.2 (5.3) | −0.7 (6.9) |
| hsCRP (mg/l) | +0.3 (4.5) | +0.3 (3.8) | −0.3 (3.6) | −0.1 (3.2) | 0.0 (3.0) | +0.2 (4.3) | −0.2 (3.9) | +0.3 (4.9) | −2.0 (6.9) | −0.9 (5.3) | +0.1 (4.9)* | −0.1 (4.8) |
| PAI-1 (ng/ml) | +10 (76) | −4.4 (72)* | +6.2 (74) | +2.7 (77) | +16 (71) | +10 (77) | +12 (82) | +7.5 (70) | +14 (79) | +4.8 (79) | +5.6 (85) | −0.7 (81) |
| Adiponectin (μg/ml) | +0.4 (9.4) | −0.3 (10) | −0.4 (8.7) | +0.1 (9.4) | +0.7 (8.2) | +0.3 (8.3) | +0.7 (9.0) | +0.5 (9.2) | +0.1 (7.4) | +0.4 (8.5) | +0.8 (8.0) | −0.1 (8.3) |
| GFR (ml/min per 1.73 m2) | −5.3 (90) | −1.9 (89) | −1.7 (90) | −0.8 (90) | +1.6 (88) | −1.6 (90) | −2.4 (87) | −2.9 (87) | +3.3 (85) | −4.7 (89) | −3.1 (89) | −3.6 (89) |
| Pool B | – | AZL-M 40 mg | AZL-M 80 mg | VAL 320 mg | – | AZL-M 40 mg | AZL-M 80 mg | VAL 320 mg | – | AZL-M 40 mg | AZL-M 80 mg | VAL 320 mg |
| N | – | 83–126 | 99–119 | 87–107 | 86–106 | 70–109 | 79–126 | 51–58 | 45–61 | 45–60 | ||
| FPG (mmol/l) | – | −0.1 (5.4) | −0.1 (5.3) | +0.0 (5.3) | – | −0.1 (5.7) | −0.1 (5.7) | −0.1 (5.7) | – | +0.1 (6.7) | −0.2 (6.9) | +0.0 (7.4) |
| Free insulin (μIU/ml) | – | −0.2 (15) | −3.3 (13) | −1.7 (12) | – | −1.6 (15) | −1.3 (17) | −4.5 (19) | – | +1.0 (15) | +3.9 (17) | −6.1 (26.7) |
| HOMA | – | −0.1 (4.2) | −1.0 (3.6) | −0.0 (2.8) | – | −0.7 (3.8) | −0.2 (4.8) | −1.5 (5.3) | – | +0.3 (4.7) | +2.2 (5.6) | −1.2 (8.2) |
| hsCRP (mg/l) | – | −0.1 (4.0) | −0.3 (3.8) | −0.3 (3.3) | – | +0.3 (4.3) | −0.9 (3.9) | −0.1 (4.5) | – | −0.2 (5.6) | +1.7 (4.9) | −0.0 (4.7) |
| PAI-1 (ng/ml) | – | +5.9 (72) | +17 (69) | +5.3 (76) | – | +9.9 (80) | +8.6 (81) | +13 (76) | – | +13 (75) | +27 (87) | +18 (81) |
| Adiponectin (μg/mL) | – | −0.5 (10) | −0.1 (8.4) | −0.2 (9.4) | – | +0.7 (8.1) | +1.3 (9.8) | +0.8 (8.2) | – | +0.9 (9.3) | +1.0 (8.3) | −0.5 (7.1) |
| GFR (ml/min per 1.73 m2) | – | −2.2 (89) | −4.3 (90) | −1.4 (91) | – | −3.4 (85) | −4.5 (89) | −1.2 (86) | – | −4.8 (86) | −3.0 (90) | +0.1 (90) |
Data are LS mean, except for GFR (arithmetic mean). AZL-M, azilsartan medoxomil; FPG, fasting plasma glucose; GFR, glomerular filtration rate (calculated using Modification of Diet in Renal Disease (MDRD) method); HOMA, homeostasis model assessment (insulin sensitivity); hsCRP, high-sensitivity C-reactive protein; OLM, olmesartan; PAI-1, plasminogen activator inhibitor-1; VAL, valsartan.
*P < 0.05 versus placebo.
†P ≤ 0.05 versus OLM; no P values available for GFR.