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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

From: A proof-of-concept study to evaluate the efficacy and safety of BTI320 on post-prandial hyperglycaemia in Chinese subjects with pre-diabetes

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

  1. *The p-values of treatment effects were obtained by ANCOVA analysis adjusted for age, gender and baseline measurements
  2. 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