Table 1.
Baseline characteristics (full analysis set population).
| Intervention Arm | Placebo Arm | p–Value | |
|---|---|---|---|
| FACTORS | n = 61 | n = 56 | |
| Sex | |||
| M [%] (n): F [%] (n) | 57% (35): 43% (26) | 48% (27): 52% (29) | - |
| Age [mean (SD years) | |||
| M: F | 61.1 (12.6): 60.8 (8.6) | 63.7 (11.4): 60.1 (9.0) | - |
| Height [mean (SD) cm] | 169.6 (10.8) | 168.5 (10.5) | 0.55 |
| Weight [mean (SD) kg] | 90.7 (19.1) | 90.0 (18.9) | 0.84 |
| BMI ≥ 25 [%] | 89% (54) | 95% (53) | 0.68 |
| FPG [5.5–6.9 mmol/L] [%] | 66% (40) | 62% (35) | 0.73 |
| FPG, mean (SD) | 5.9 (0.9) mmol/L | 5.9 (0.8) mmol/L | 0.94 |
| OGTT 1 h ≥ 8.6 mmol/L [%] | 93% (57) | 95% (53) | - |
| 1 h post OGTT mean (SD) | 11.3 (2.4) mmol/L | 10.7 (3.1) mmol/L | 0.25 |
| 2 h post OGTT mean (SD) | 8.2 (3.1) mmol/L | 7.8 (3.0) mmol/L | 0.49 |
| Insulin mU/L fast mean (SD) | 16.6 (8.1) | 17.6 (11.4) | 0.60 |
| Insulin mU/L 1 h mean (SD) | 130.0 (76.7) | 130.9 (71.9) | 0.95 |
| Insulin mU/L 2 h mean (SD) | 101.4 (73.8) | 102.7 (71.5) | 0.93 |
| HbA1c % fast mean (SD) | 5.7 (0.4) | 5.6 (0.5) | 0.25 |
| With prescribed metformin FBG mmol/L 1 h post OGTT mean (SD) 2 h post OGTT mean (SD) |
7/61 (11.5%) 6.2 (0.6) m12.9 (3.1) 10.8 (5.0) |
10/56 (17.9%) 5.4 (0.5) 10.8 (3.1) 7.5 (3.4) |
0.35 |
Notes: BMI = body mass index; FPG = fasting plasma glucose; OGTT = oral glucose tolerance test.