Table 2.
Changes in glycemic and metabolic indices from baseline between low dose or high dose BTI320 and placebo in the intention-to-treat analysis
| Clinical Variable | Low Dose BTI320 | High Dose BTI320 | ||||||
|---|---|---|---|---|---|---|---|---|
| Week 4 | Week 16 | Week 4 | Week 16 | |||||
| Mean Difference (95% CI) | p* | Mean Difference (95% CI) | p* | Mean Difference (95% CI) | p* | Mean Difference (95% CI) | p* | |
| Serum fructosamine, μmol/L | 2.46 (−6.28, 11.20) | 0.57 | 1.14 (−9.17, 11.45) | 0.83 | −1.57 (− 10.3, 7.11) | 0.72 | − 0.92 (− 11.1, 9.27) | 0.86 |
| HbA1c, % | – | – | − 0.01 (− 0.13, 0.10) | 0.83 | – | – | − 0.04 (− 0.16, 0.08) | 0.48 |
| 2-h glucose AUC post-MTT, mmol/L×min | 65.0 (− 14.4, 144.5) | 0.11 | −13.6 (− 99.6, 72.3) | 0.75 | 68.9 (− 9.9, 147.7) | 0.09 | 40.0 (−43.9, 123.9) | 0.34 |
| 2-h insulin AUC post-MTT, mIU/L×min | 1219.2 (− 1129.0, 3567.7) | 0.30 | −980.0 (− 2604.0, 643.8) | 0.23 | 1111.2 (− 1211.0, 3433.2) | 0.34 | 323.9 (− 1269.0, 1916.6) | 0.68 |
| 2-h C-peptide AUC post-MTT, μg/L×min | 128.4 (−22.4, 279.2) | 0.09 | 15.0 (− 99.6, 129.6) | 0.79 | 101.8 (− 47.3, 250.9) | 0.18 | 60.1 (− 52.5, 172.6) | 0.29 |
| 2-h GLP-1 AUC post-MTT, pmol/L×min | 42.8 (− 144.8, 230.3) | 0.65 | − 120.2 (− 385.3, 144.9) | 0.37 | 32.2 (− 149.7, 214.1) | 0.72 | 49.0 (− 198.1, 296.2) | 0.69 |
| Systolic BP, mmHg | −6.4 (− 15.3, 2.5) | 0.16 | −2.2 (− 9.8, 5.5) | 0.57 | − 2.4 (− 11.2, 6.4) | 0.58 | 1.0 (− 6.6, 8.6) | 0.79 |
| Body weight, kg | 0.0 (−1.2, 1.3) | 0.95 | −1.7 (−3.2, − 0.1) | 0.03 | 0.7 (− 0.5, 1.9) | 0.26 | − 0.1 (− 1.7, 1.4) | 0.86 |
| Total cholesterol, mmol/L | 0.06 (− 0.31, 0.43) | 0.75 | 0.03 (− 0.39, 0.44) | 0.90 | − 0.21 (− 0.58, 0.16) | 0.26 | − 0.22 (− 0.63, 0.20) | 0.30 |
| LDL-cholesterol, mmol/L | 0.07 (− 0.28, 0.41) | 0.69 | 0.10 (− 0.28, 0.48) | 0.59 | − 0.26 (− 0.60, 0.09) | 0.14 | − 0.18 (− 0.56, 0.20) | 0.35 |
| hs-CRP, mg/L | 0.77 (−0.79, 2.33) | 0.33 | 0.62 (− 1.32, 2.57) | 0.52 | 0.15 (− 1.39, 1.70) | 0.84 | 1.13 (−0.78, 3.05) | 0.24 |
*The p-values of treatment effects were obtained by ANCOVA analysis adjusted for age, gender and baseline measurements
AUC area under curve, BP blood pressure, CI confidence interval, CRP C-reactive protein, GLP-1 glucagon-like peptide-1, HbA1c glycated haemoglobin, hs-CRP high-sensitivity C-reactive protein, LDL low density-lipoprotein, MTT meal tolerance test