Table 3 Effectiveness and safety of BI with or without metformin after 6 months - results of propensity score regression^a

The full population ( N  = 12,358)

N  = 6621

N  = 5737

 HbA1c control, % (95 % CI)

  ≤6.5 %

25.0 (20.9, 29.5)

22.1(18.4, 26.3)

0.0024

  <7.0 %

39.9 (34.1, 45.0)

36.4 (31.7, 41.3)

0.0011

 HbA1c level (%), mean (95 % CI)

  Mean level at v3

7.4 (7.3, 7.6)

7.5 (7.4, 7.6)

0.0302

  Change from baseline

-1.8 (-1.9, -1.6)

-1.7 (-1.9, -1.5)

0.1839

 FPG control (<7.0 mmol), % (95 % CI)

36.0 (31.2, 41.0)

33.5 (28.9, 38.5)

0.0515

 FPG level (mmol/L), mean (95 % CI)^b

  Mean level at v3

8.3 (8.1, 8.5)

8.3 (8.1, 8.5)

0.6875

  Change from baseline

-2.9 (-3.3, -2.5)

-3.0 (-3.3, -2.5)

0.5169

 Insulin dose (U/day/kg), mean (95 % CI)

  Insulin dose at v3

0.33 (0.32, 0.33)

0.34 (0.33, 0.34)

<0.0001

  Change from v1 to v3

0.064 (0.059, 0.060)

0.068 (0.063, 0.070)

0.0035

 Weight (kg), mean (95 % CI)

  Mean level at v3

70.1 (69.3, 70.0)

70.3 (69.4, 71.2)

0.4862

  Change from baseline

0.35 (0.11, 0.59)

0.37 (0.13, 0.62)

0.7223

 Hypoglycemia, % (95 % CI)

11.2 (9.1, 13.8)

10.4 (8.4, 12.8)

0.2965

The sub-population ( N = 8035)

N = 4269

N = 3799

 HbA1c control, % (95 % CI)

  ≤6.5 %

30.1 (28.4, 31.8)

25.1 (23.4, 26.8)

0.0003

  <7.0 %

47.9 (46.1, 49.7)

41.9 (39.9, 43.8)

0.0001

 HbA1c level (%), mean (95 % CI)

  Mean level at v3

7.2 (7.2, 7.3)

7.3 (7.3, 7.4)

0.0009

  Change from baseline

-2.0 (-2.1, -1.9)

-1.9 (-2.0, -1.9)

0.4175

 FPG control (<7.0 mmol), % (95 % CI)

49.6 (47.5, 51.8)

46.8 (44.5, 49.1)

0.1319

 FPG level (mmol/L), mean (95 % CI) ^c

  Mean level at v3

7.5 (7.4, 7.6)

7.6 (7.5, 7.7)

0.2212

  Change from baseline

-3.7 (-3.8, -3.5)

-3.7 (-3.9, -3.5)

0.8499

 Insulin dose (U/day/kg), mean (95 % CI)

  Insulin dose at v3

0.21 (0.20, 0.21)

0.22 (0.21, 0.21)

<0.0001

  Change from v1 to v3

0.033 (0.031, 0.035)

0.037 (0.035, 0.039)

0.0073

 Weight (kg), mean (95 % CI)

  Mean level at v3

67.4 (67.0, 67.8)

67.7 (67.3, 68.1)

0.2965

  Change from baseline

-0.12 (-0.22, -0.02)

0.15 (0.042, 0.24)

0.0013

 Hypoglycemia, % (95 % CI)

7.2 (6.3, 8.2)

6.9 (6.0, 8.0)

0.6892