Table 2. Week 16 values and change from baseline for efficacy parameters in the FAS population.
| Parameter | Normal (n = 111) | Overweight (n = 111) | Obese (n = 112) | P value | |
| HbA1c (%) | |||||
| Mean (SD) | 6.56 (0.64) | 6.60 (0.60) | 6.58 (0.58) | 0.664† | |
| LS mean change* (95% CI) | –1.84 (–1.95, –1.73) | –1.78 (–1.89, –1.67) | –1.78 (–1.89, –1.67) | 0.664† | |
| FPG (mmol/L) | |||||
| Mean (SD) | 6.54 (1.15) | 6.68 (1.42) | 6.42 (1.19) | 0.461‡ | |
| Mean change (SD) | –1.98 (1.79) | –2.17 (2.12) | –2.14 (2.03) | 0.461‡ | |
| 95% CI | –2.32, –1.64 | –2.57, –1.77 | –2.52, –1.76 | ||
| TC (mmol/L) | |||||
| Mean (SD) | 4.77 (0.77) | 4.95 (1.01) | 4.80 (0.93) | 0.031‡ | |
| Mean change (SD) | –0.39 (0.92) | –0.05 (0.96) | –0.14 (0.82) | 0.03‡ | |
| 95% CI | –0.56, –0.21 | –0.23, 0.13 | –0.30, 0.02 | ||
| LDL-C (mmol/L) | |||||
| Mean (SD) | 2.91 (0.61) | 2.88 (0.85) | 2.87 (0.77) | 0.451‡ | |
| Mean change (SD) | –0.31 (0.57) | –0.14 (0.66) | –0.18 (0.63) | 0.451‡ | |
| 95% CI | –0.42, –0.20 | –0.27, –0.02 | –0.30, –0.06 | ||
| HDL-C (mmol/L) | |||||
| Mean (SD) | 1.23 (0.26) | 1.14 (0.30) | 1.14 (0.28) | 0.143‡ | |
| Mean change (SD) | 0.06 (0.20) | 0.02 (0.34) | 0.03 (0.20) | 0.143‡ | |
| 95% CI | 0.02, 0.09 | –0.04, 0.09 | –0.01, 0.07 | ||
| TG (mmol/L) | |||||
| Mean (SD) | 1.71 (0.97) | 2.90 (3.89) | 2.27 (1.67) | 0.021‡ | |
| Mean change (SD) | –0.17 (2.07) | 0.26 (3.32) | –0.04 (2.20) | 0.021‡ | |
| 95% CI | –0.56, 0.22 | –0.37, 0.90 | –0.47, 0.39 | ||
| BMI (kg/m2) | |||||
| Mean (SD) | 22.01 (1.53) | 25.04 (1.51) | 29.09 (2.31) | NC | |
| Mean change (SD) | –0.54 (0.84) | –1.00 (1.06) | –1.04 (1.11) | NC | |
| Waist/hip ratio | |||||
| Mean (SD) | 0.90 (0.07) | 0.94 (0.08) | 0.94 (0.08) | <0.0001§ | |
| Mean change (SD) | –0.02 (0.09) | –0.01 (0.10) | –0.01 (0.08) | 0.446§ | |
HbA1c, glycosylated hemoglobin; FPG, fasting plasma glucose; BMI, body mass index; FAS, full analysis set; LS, least squares; SD, standard deviation; CI, confidence interval; TC, total cholesterol; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol; TG, triglycerides; NC, not calculated. *LS means of change from baseline are adjusted by baseline HbA1c.
†
P values are from analysis of covariance (ANCOVA) with BMI group as an effect and the baseline HbA1c value as a covariate.
‡
P values are from ANCOVA.
§
P values are from analysis of variance.