Skip to main content

Table 1 Summary of blood glucose control endpoints in the modified intention-to-treat analysis population with last observation carried forward for missing observations at Week 24

From: A randomised, open-labelstudy of insulin glargine or neutral protamine Hagedorn insulin in Chinese paediatric patients with type 1 diabetes mellitus

 

Insulin glargine

NPH insulin

 

(n = 107)

(n = 54)

 

n

Mean ± SD

Median

n

Mean ± SD

Median

   

(Q1, Q3)

  

(Q1, Q3)

HbA1c, % (mmol/mol)a

 Baseline

107

8.87 ± 1.21

8.90 (7.90, 9.70)

54

9.12 ± 1.29

8.90 (7.90, 10.20)

(73.47 ± 13.27)

(73.77 [62.84, 81.97])

(76.16 ± 14.04)

(73.77 [63.11, 87.98])

 Week 24

103

8.57 ± 1.47

(8.40 [7.70, 9.20])

50

8.60 ± 1.81

8.30 (7.60, 9.40)

(70.13 ± 16.06)

(68.31 [61.20,76.50])

 

(70.49 ± 19.79)

(67.21 [59.56, 78.96])

 Changeb

103

−0.31 ± 1.56

−0.50 (–1.20, 0.60)

50

−0.57 ± 1.68

−0.40 (–1.20, 0.40)

(–3.30 ± 19.52)

(–3.28 [–14.75, 7.65])

(–5.57 ± 21.51)

(–3.83 [-15.30, 5.19])

 Week 24 (LOCF)c

107

8.63 ± 1.54

8.40 (7.70, 9.20)

51

8.59 ± 1.79

8.30 (7.60, 9.40)

(70.79 ± 16.81)

(68.31 [61.20, 77.05])

(70.43 ± 19.60)

(67.21 [59.56, 78.69])

 Change (LOCF)b

107

−0.25 ± 1.68

−0.50 (–1.20, 0.60)

51

−0.54 ± 1.67

−0.40 (–1.20, 0.40)

(–2.69 ± 18.32)

(–5.46 [–13.11, 6.56])

(–5.55 ± 20.32)

(–3.28 [–15.30, 4.92])

LS Mean difference

0.16 (0.26)

95% CI

−0.36 to 0.68

HbA1c at Week 24, n (%)a

 <7.5% (<58.5 mmol/mol)d

107

20 (18.7)

--

51

11 (21.6)

--

 7.5% to 9.0% (58.5–74.9 mmol/mol)

107

56 (52.3)

--

51

26 (51.0)

--

 >9.0% (>74.9 mmol/mol)

107

31 (29.0)

--

51

14 (27.5)

--

Fasting blood glucose, mmol/Le

 Baseline

105

10.38 ± 3.38

10.08 (8.22, 12.24)

52

10.20 ± 2.75

10.59 (8.38, 11.88)

 Week 24

96

9.45 ± 2.60

9.17 (7.56, 11.01)

44

10.89 ± 3.19

10.14 (8.51, 12.74)

 Changeb

94

−0.85 ± 3.73

−0.05 (–2.95, 1.24)

42

0.54 ± 3.34

0.49 (–1.45, 3.66)

 Week 24 (LOCF)c

107

9.61 ± 2.63

9.30 (7.72, 11.59)

54

11.29 ± 3.35

10.81 (8.84, 13.00)

 Change (LOCF)b

105

−0.76 ± 3.56

−0.05 (–2.47, 1.23)

52

1.07 ± 3.64

0.71 (–1.45, 3.86)

LS Mean difference

−1.69 (0.47)

95% CI

−2.62 to –0.76

Nocturnal blood glucose, mmol/Lf

 Baseline

88

8.89 ± 4.47

8.00 (5.50, 11.80)

45

9.38 ± 4.81

8.10 (6.00, 12.00)

 Week 24

89

9.44 ± 4.88

8.80 (5.60, 11.90)

42

8.88 ± 3.94

8.75 (5.80, 11.20)

 Changeb

75

0.42 ± 6.26

0.30 (–3.60, 4.60)

35

−0.14 ± 5.97

1.60 (–3.20, 3.70)

 Week 24 (LOCF)c

106

9.44 ± 4.83

8.80 (5.60, 12.20)

54

9.56 ± 4.39

9.05 (6.20, 12.80)

 Change (LOCF)b

88

0.59 ± 6.16

0.15 (–3.00, 3.95)

45

0.24 ± 5.80

1.60 (–3.00, 3.70)

LS Mean difference

−0.03 (0.88)

95% CI

−1.77 to 1.70

Eight-point SMBG, mmol/L

 Baseline

104

10.01 ± 3.30

9.46 (7.54, 11.72)

53

10.00 ± 2.98

9.66 (7.51, 11.83)

 Week 24

94

10.00 ± 3.10

9.46 (7.75, 11.85)

45

9.42 ± 2.74

8.86 (7.91, 10.81)

 Changeb

92

0.28 ± 4.39

0.28 (–2.30, 2.84)

44

−0.58 ± 3.99

−0.59 (–2.96, 1.99)

 Week 24 (LOCF)c

107

9.94 ± 3.00

9.49 (7.75, 11.85)

54

9.75 ± 2.83

9.02 (7.98, 11.25)

 Change (LOCF)b

104

0.01 ± 4.30

0.01 (–2.58, 2.44)

53

−0.28 ± 3.92

−0.21 (–2.87, 2.69)

LS Mean difference

0.31 (0.50)

95% CI

−0.68 to 1.30

  1. aThe analysis excluded measurements obtained >14 days after treatment cessation
  2. bChange from Baseline to Week 24
  3. cFor Week 24 (LOCF), the analysis included measurements obtained ≤14 days after the last dose of study medication
  4. dAnalysis of number (%) of patients with HbA1c <7.5% (<58.5 mmol/mol) at Week 24 was not statistically significant; P = 0.6594
  5. eThe analysis excluded measurements obtained >1 day after treatment cessation
  6. fNocturnal blood glucose was measured at 03:00 a.m.
  7. LS least square, Q1 quartile 1, Q3 quartile 3 SD, standard deviation, SMBG self-monitored blood glucose
Back to article page

BMC Endocrine Disorders

ISSN: 1472-6823

Contact us