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Table 2 Review of phase III insulin analog clinical trials

From: Systematic literature review of use of blood glucose monitoring in phase III clinical studies of insulin analogs

 

Rapid-acting insulin analogs

Pre-mixed insulin analogs

Total

Insulin aspart (Novo Rapid)

Insulin glulisine (Apidra)

Insulin lispro (Humalog)

Biphasic insulin aspart (Novo Mix)

Insulin lispro mix (Humalog Mix)

Rapid-acting

Pre-mix

All insulin analog studies

Total number of trials (n)

8

16

4

12

5

28

17

45

All insulin analog studies (n = 45)

Proportion of trials reporting BG measurement (%)

100 %

100 %

100 %

100 %

100 %

100 %

100 %

100 %

Reported BG by SMBG, laboratory or both (n = 45)

Reported BG measurement by SMBG only (%)

100 %

82 %

75 %

83 %

80 %

86 %

82 %

84 %

Reported BG measurement by laboratory measurement only (%)

0 %

12 %

0 %

0 %

20 %

7 %

6 %

7 %

Reported BG by both SMBG and laboratory measurements (%)

0 %

6 %

25 %

17 %

0 %

7 %

12 %

9 %

Reported regular insulin dose adjustments (using BG measurements, n = 45)

Reported dose adjustments according to BG measurement (%)

87.5 %

100 %

100 %

91.6 %

60.0 %

96.4 %

82.4 %

91.1 %

Reported regular dose adjustments by patient or physician (using BG measurements, n = 45)

Reported dose adjustments by patient (%)

25.0 %

43.7%

0 %

41.7 %

0 %

32.1 %

29.4 %

31.1 %

Reported dose adjustments by physician (%)

37.5 %

25.0 %

100 %

33.3 %

40.0 %

39.3 %

35.3 %

37.8 %

Reported dose adjustments by patient and physician (%)

0 %

6.3 %

0 %

8.3 %

0 %

3.6 %

5.9 %

4.4 %

Reported dose adjustments, not specified by patient or physician (%)

25.0 %

25.0 %

0 %

8.3 %

20.0 %

21.4 %

11.8 %

17.8 %

Reported regular dose adjustments using SMBG measurements (n = 42)

Patient self-adjustments using SMBG values (%)

25.0 %

50 %

0 %

41.7 %

0 %

34.6 %

31.3 %

33.3 %

Physician adjustments using SMBG values (%)

37.5 %

28.6 %

75 %

33.3 %

50 %

38.5 %

37.5 %

38.1 %

Patient and physician adjustments using SMBG values (%)

0 %

7.1 %

0 %

8.3 %

0 %

3.8 %

6.3 %

4.8 %

Dose adjustments using SMBG mentioned but not specified whether by patient or physician (%)

25.0 %

7.1 %

0 %

0 %

25 %

11.5 %

6.3 %

9.5 %

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