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Table 1 Baseline clinical characteristics of subjects in low dose BTI320, high dose BTI320 and placebo groups

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

 

Placebo

Low Dose BTI320

High Dose BTI320

Number

12

24

24

Demographics

 Age, years

57.1 ± 10.9

54.1 ± 8.6

58.5 ± 8.5

 Male, % (n)

25.0 (3)

54.2 (13)

50.0 (12)

Metabolic Parameters

 Body weight, kg

63.9 ± 20.0

74.2 ± 16.9

71.0 ± 16.2

 Body mass index, kg/m2

25.1 ± 4.3

28.0 ± 5.8

26.9 ± 4.4

 Waist, cm

88.0 ± 15.7

95.0 ± 15.6

90.6 ± 9.1

 Systolic BP, mmHg

127.8 ± 8.7

121.7 ± 13.2

125.4 ± 16.2

 Diastolic BP, mmHg

80.4 ± 7.3

78.4 ± 6.8

78.7 ± 7.2

 Total cholesterol, mmol/L

5.3 ± 0.8

4.9 ± 1.1

4.9 ± 1.0

 LDL-cholesterol, mmol/L

3.3 ± 0.6

2.9 ± 0.9

2.9 ± 0.8

 Triglyceride, mmol/L

1.4 ± 0.6

1.2 ± 0.4

1.4 ± 0.8

 HDL-cholesterol, mmol/L

1.5 ± 0.3

1.5 ± 0.3

1.4 ± 0.4

 Fructosamine, μmol/L

278.9 ± 22.0

268.5 ± 18.3

272.2 ± 20.2

 HbA1c, % (mmol/mol)

6.1 ± 0.3

(43 ± 2.2)

6.0 ± 0.3

(42 ± 2.1)

6.0 ± 0.30

(42 ± 2.1)

 Hypertension, % (n)

58.3 (7)

45.8 (11)

54.2 (13)

 Dyslipidemia, % (n)

33.3 (4)

25.0 (6)

41.7 (10)

 Obesity, % (n)

25.0 (3)

16.7 (4)

20.8 (5)

Glycemic Status

 IFG, % (n)

0.0 (0)

12.5 (3)

4.2 (1)

 IGT, % (n)

41.7 (5)

41.7 (10)

33.3 (8)

 Both IFG/IGT, % (n)

33.3 (4)

16.7 (4)

29.2 (7)

 NGT and HbA1c 5.7–6.4% (39–46 mmol/mol) only, % (n)

25.0 (3)

29.2 (7)

33.3 (8)

CGM Parameters

 1-h AUCpp, mmol/L×hour

6.33 ± 0.64

5.91 ± 0.53

6.22 ± 0.72

 2-h AUCpp, mmol/L×hour

13.49 ± 1.43

12.68 ± 1.21

13.64 ± 1.87

 3-h AUCpp, mmol/L×hour

20.20 ± 2.20

18.90 ± 1.69

20.20 ± 2.59

 72-h AUC-180, mmol/L×hour

2.73 ± 7.64

0.40 ± 1.85

1.71 ± 3.35

 MBG, mmol/L

6.45 ± 0.54

6.01 ± 0.45

6.20 ± 0.63

 MPMG, mmol/L

8.07 ± 1.00

7.45 ± 0.78

8.20 ± 1.31

 MAGE, mmol/L

3.21 ± 3.16

2.06 ± 0.69

2.68 ± 1.01

 CV, %

18.00 ± 7.60

15.49 ± 4.43

19.07 ± 6.61

 SD, mmol/L

1.18 ± 0.59

0.93 ± 0.28

1.19 ± 0.44

  1. Expressed as mean ± standard deviation, or percentage (number) as appropriate
  2. AUC area-under-curve, AUCpp post-prandial incremental area-under-curve, BP blood pressure, CGM Continuous Glucose monitoring, CV coefficient of variation, HbA1c glycated haemoglobin, HDL high density-lipoprotein, IFG impaired fasting glucose, IGT impaired glucose tolerance, LDL low density-lipoprotein, MAGE mean amplitude of glucose excursion, MBG mean blood glucose, MPMG mean post-meal maximum glucose, NGT normal glucose tolerance, SD standard deviation