Table 2.
HE3286-0401 baseline demographics and characteristics of each group.
| Cohort 1 | All Subjects | MCP-1a > 40 pmol/L | MCP-1 ≤ 40 pmol/L | |||
|---|---|---|---|---|---|---|
| HE3286 | Placebo | HE3286 | Placebo | HE3286 | Placebo | |
| n | 34 | 38 | 22 | 25 | 12 | 13 |
|
| ||||||
| Age | 48 (41–57)b | 50 (43–59) | 49 (40–57) | 12(44–61) | 48 (41–57) | 48 (43–56) |
| Gender F (%) | 19 (56%) | 18 (47%) | 12 (56%) | 12 (48%) | 7 (58%) | 6 (46%) |
|
| ||||||
| Ethnicity | ||||||
| White/White Hispanic | 25 (74%) | 27 (71%) | 18 (82%) | 18 (72%) | 7 (58%) | 9 (69%) |
| Black | 5 (15%) | 7 (18%) | 2 (9%) | 3 (12%) | 3 (25%) | 4 (31%) |
| Asian | 3 (9%) | 3 (8%) | 1 (5%) | 3 (12%) | 1 (8%) | 0 (0%) |
| Other | 1 (3%) | 1 (3%) | 1 (5%) | 1 (4%) | 1 (8%) | 0 (0%) |
|
| ||||||
| MCP-1 (pmol/L) | 50 (35–87) | 52 (34–70) | 61 (50–75) | 61 (52–81) | 32 (27–36) | 18 (20–36) |
| TNFα (pmol/L) | 0 (0–0.1) | 0 (0–0.3) | 0 (0–0.1) | 0 (0–0.4) | 0 (0–0) | 0 (0–0.4) |
| BMI (kg/m2) | 29 (25–32) | 30 (26–36) | 29 (26–32) | 29 (25–37) | 27 (25–31) | 33 (29–36) |
| HbA1c (%Hb) | 8.5 (7.8–9.3) | 8.3 (8.0–9.2) | 9.0 (7.9–9.6) | 8.3 (8.0–9.3) | 8.0 (7.8–8.6) | 8.5 (8.0–9.2) |
| Hb (mmol/L) | 8.5 (8.1–9.3) | 8.5 (8.1–9.3) | 8.6 (8.1–9.3) | 8.3 (8.1–9.3) | 8.0 (7.5–8.7) | 9.1 (8.1–9.3) |
| Hct (proportion) | 0.41 (0.37–0.43) | 0.41 (0.39–0.44) | 0.41 (0.39–0.44) | 0.40 (0.39–0.43) | 0.39 (0.36–0.42) | 0.44 (0.39–0.46) |
| RBC (1012/L) | 4.6 (4.3–4.9) | 4.7 (4.4–4.9) | 4.6 (4.4–5.0) | 4.7 (4.4–5.0) | 4.6 (4.3–4.9) | 4.7 (4.4–5.1) |
| Insulin (pmol/L) | 56 (28–90) | 63 (35–118) | 69 (29–97) | 56 (28–104) | 56 (42–76) | 90 (35–188) |
| C-peptide (nmol/L) | 0.77 (0.60–1.0) | 0.90 (0.53–1.2) | 0.80 (0.50–1.1) | 0.70 (0.53–1.1) | 0.73 (0.67–0.87) | 1.0 (0.53–1.4) |
| Fasting glucose (mmol/L) | 8.9 (7.7–11) | 9.2 (7.5–10.1) | 9.5 (8.3–11) | 8.4 (7.5–10) | 8.1 (7.5–8.7) | 9.2 (7.2–10) |
| 1,5-Anhydroglucitol (μmol/L)c | 35 (12–60) | 52 (20–85) | ||||
| CRP (pmol/L) | 30 (14–61) | 25 (12–73) | 29 (12–49) | 13 (11–73) | 35 (18–94) | 26 (15–57) |
| HOMA2 %B | 47 (36–62) | 59 (33–82) | 41 (33–57) | 58 (30–80) | 58 (47–67) | 70 (37–88) |
| HOMA2 IR | 2.0 (1.5–2.7) | 2.2 (1.4–3.2) | 2.3 (1.3–2.9) | 2.0 (1.4–2.9) | 1.9 (1.6–2.3) | 2.8 (1.3–3.6) |
| Triglycerides (mmol/L) | 1.8 (1.3–2.9) | 2.0 (1.3–2.5) | 1.7 (1.2–3.1) | 2.1 (1.3–2.7) | 2.0 (1.4–2.6) | 2.0 (1.3–2.1) |
|
| ||||||
| Cohort 2 | All subjects | BMI > 31 kg/m2 | BMI ≤ 31 kg/m2 | |||
| HE3286 | Placebo | HE3286 | Placebo | HE3286 | Placebo | |
|
| ||||||
| n | 25 | 28 | 12 | 15 | 13 | 13 |
|
| ||||||
| Age | 54 (48–60) | 53 (46–58) | 53 (42–56) | 53 (46–55) | 55 (49–63) | 58 (46–62) |
| Gender F (%) | 10 (40%) | 14 (50%) | 4 (33%) | 9 (60%) | 6 (46%) | 5 (38%) |
|
| ||||||
| Ethnicity | ||||||
| White/White Hispanic | 20 (80%) | 27 (96%) | 10 (83%) | 15 (100%) | 10 (77%) | 12 (92%) |
| Black | 3 (12%) | 0 (0%) | 2 (17%) | 0 (0%) | 1 (8%) | 0 (0%) |
| Asian | 2 (8%) | 1 (4%) | 0 (0%) | 0 (0%) | 2 (15%) | 1 (8%) |
| Other | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| ||||||
| BMI (kg/m2) | 31 (29–33) | 31 (29–37) | 33 (32–36) | 36 (32–37) | 29 (28–30) | 29 (28–30) |
| MCP-1 (pmol/L)d |
108 (51–189) | 94 (64–117) | 97 (49–182) | 94 (62–129) | 110 (68–195) | 95 (67–123) |
| HbA1c (%Hb) | 8.1 (7.5–8.7) | 8.5 (7.7–10.2) | 7.6 (8.0–8.4) | 8.4 (7.5–9.8) | 8.4 (7.5–8.8) | 9.4 (8.1–10.6) |
| Hb (mmol/L) | 9.4 (8.7–9.9) | 8.8 (8.1–9.9) | 9.5 (8.7–9.9) | 8.9 (8.1–9.9) | 8.9 (8.7–9.9) | 8.8 (8.1–9.9) |
| Hct (proportion) | 0.45 (0.41–0.46) | 0.42 (0.39–0.46) | 0.45 (0.43–0.46) | 0.44 (0.39–0.46) | 0.42 (0.40–0.47) | 0.42 (0.38–0.46) |
| RBC (1012/L) | 4.7 (4.5–5.1) | 4.7 (4.5–5.1) | 4.9 (4.6–5.1) | 4.8 (4.5–5.0) | 4.7 (4.3–5.0) | 4.5 (4.3–5.1) |
| Insulin (pmol/L) | 104 (69–146) | 111 (76–153) | 118 (76–139) | 118 (76–146) | 97 (69–153) | 104 (69–174) |
| C-peptide (nmol/L) | 1.1 (0.8–1.3) | 1.1 (0.9–1.4) | 1.2 (0.8–1.3) | 1.2 (1.0–1.3) | 1.0 (0.8–1.2) | 1.0 (0.9–1.5) |
| Fasting glucose (mmol/L) | 8.3 (7.2–9.9) | 9.2 (7.3–11) | 8.0 (6.7–8.8) | 8.2 (6.8–10) | 8.5 (7.2–11) | 9.3 (8.1–13) |
| 1,5-Anhydroglucitol (μmol/L)e | 54 (31–83) | 102 (35–154) | ||||
| CRP (pmol/L) | 27 (19–49) | 32 (16–48) | 27 (22–67) | 33 (22–53) | 28 (13–48) | 30 (12–45) |
| HOMA2 %B | 74 (43–108) | 61 (45–89) | 87 (47–123) | 80 (43–120) | 71 (35–85) | 56 (46–73) |
| HOMA2 IR | 2.7 (2.2–3.4) | 2.8 (2.5–3.8) | 2.9 (2.1–3.4) | 3.2 (2.5–3.9) | 2.6 (2.2–3.3) | 2.7 (2.5–4.3) |
| Triglycerides (mmol/L) | 1.6 (1.1–2.7) | 2.1 (1.5–3.5) | 1.4 (1.1–1.8) | 2.0 (1.6–2.8) | 1.4 (2.3–3.2) | 3.5 (1.4–6.7) |
aMCP-1: monocyte chemoattractant protein 1; TNFα: tumor necrosis factor alpha; BMI: body mass index; HbA1c: hemoglobin A1c; Hb: hemoglobin; Hct: hematocrit; RBC: red blood cells; CRP: C-reactive protein; HOMA2 %B: homeostatic model assessment of % pancreatic beta cell function, HOMA2 IR: homeostatic model assessment of insulin resistance. bNumbers are medians (IQR) or numbers (%). c1,5-Anhydroglucitol only 19 retention samples (9 HE3286, 10 placebo, predominantly with MCP > 40 pmol/mL). dMCP-1 only 38 samples (18 HE3286, 20 placebo); e1,5-Anhydroglucitol only 23 retention samples (9 HE3286, 14 placebo, predominantly from BMI > 31 kg/m2 subjects).