Table 2.
Participant Characteristics and Outcomes during Run-in
| OVERALL | RANDOMIZED | ||||
|---|---|---|---|---|---|
| (N=927) | YES (N=704) | NO (N=223) | |||
| 25th, 50th, 75th percentiles | |||||
| Days from screening to run-in | 18, 25, 36 | 18, 25, 35 | 19, 27, 45 | ||
| Run-in length (days) | 59, 70, 91 | 62, 71, 89 | 23, 57, 109 | ||
| mean (SD) or % | P-value | ||||
| Weight change* (kg) | −0.43 (4.01) | −0.68 (3.91) | 0.71 (4.27) | <0.01 | |
| z-BMI change* | −0.046 (0.123) | −0.049 (0.108) | −0.033 (0.177) | 0.15 | |
| HbA1c† change* | −1.33 (1.91) | −1.45 (1.84) | −0.74 (2.14) | <0.01 | |
| Last HbA1c | < 8% | 90.9% | 100.0% | 46.9% | |
| 8–10% | 6.0% | -- | 35.2% | ||
| > 10% | 3.1% | -- | 17.9% | ||
| Co-morbid conditions‡ | |||||
| Total cholesterol (mg/dL) | 159.3 (43.5) | 156.3 (36.8) | 168.7 (59.0) | <0.01 | |
| HDL cholesterol (mg/dL) | 40.2 (9.9) | 39.8 (9.4) | 41.6 (11.4) | 0.02 | |
| Triglycerides (mg/dL) | 143.5 (332.7) | 127.0 (90.9) | 195.4 (657.0) | <0.01 | |
*
Change from screening visit to final run-in visit.
†
HbA1c sample size N=704 for randomized and N=145 for non-randomized for an overall N=849.
‡
Only statistically significant variables are given; those tested but not significant were systolic blood pressure, diastolic blood pressure, LDL cholesterol, and liver function tests.