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