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Table 3 Patient reported outcomes

From: Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents – a randomized, prospective, crossover, open clinical trial

 

Baseline (Visit 2)

End of period 1

End of period 2

p-value*

ITEQ

    

Sequence A

No insulin Tx

74.2 ± 11.8

73.3 ± 12.9

0.52

Sequence B

No insulin Tx

73.0 ± 13.7

73.2 ± 12.0

0.74

p-value**

 

0.42

0.97

 

DTSQs Hyperglycemia

    

Sequence A

4.2 ± 1.53

2.2 ± 1.57

2.3 ± 1.76

n.a.

Sequence B

4.2 ± 1.60

2.2 ± 1.73

2.1 ± 1.70

n.a.

p-value**

 

1.0

0.32

 

DTSQs Hypoglycemia

    

Sequence A

0.7 ± 1.32

1.2 ± 1.57

1.3 ± 1.68

n.a.

Sequence B

0.6 ± 1.15

1.0 ± 1.47

1.1 ± 1.52

n.a.

p-value**

 

0.25

0.29

 
 

Baseline (Visit 2)

∆ from baseline

∆ from end of period 1

p-value*

PAID

    

Sequence A

21.3 ± 15.7

−5.1 ± 11.4

0.7 ± 10.4

<0.0001

Sequence B

23.3 ± 15.4

−4.4 ± 14.8

0.5 ± 11.7

0.0049

p-value**

 

0.61

0.89

 

SF-12® mental health

    

Sequence A

50.2 ± 9.34

0.5 ± 7.91

0.4 ± 7.56

0.68

Sequence B

49.8 ± 10.5

0.8 ± 9.21

−0.6 ± 8.59

0.24

p-value**

 

0.77

0.34

 

SF-12® physical health

    

Sequence A

50.5 ± 9.06

0.5 ± 7.94

−0.3 ± 8.04

n.a.

Sequence B

49.4 ± 9.20

0.9 ± 7.99

0.6 ± 7.29

n.a.

p-value**

 

0.70

0.36

 

EQ-5D descriptive

    

Sequence A

0.89 ± 0.16

−0.009 ± 0.1727

−0.005 ± 0.1787

0.91

Sequence B

0.900 ± 0.1682

0.001 ± 0.1606

−0.009 ± 0.1637

0.88

p-value**

 

0.62

0.85

 

EQ-5D VAS

    

Sequence A

0.867 ± 0.1730

−0.000 ± 0.1646

0.001 ± 0.1557

n.a.

Sequence B

0.862 ± 0.1819

0.009 ± 0.1655

−0.013 ± 0.1566

n.a.

p-value**

 

0.64

0.45

 

DTSQs

    

Sequence A

27.9 ± 7.72

3.2 ± 8.04

−0.8 ± 6.38

<0.0001

Sequence B

27.2 ± 7.37

2.1 ± 7.36

0.3 ± 6.92

0.0420

p-value**

 

0.22

0.16

 
  1. Legend: * Paired t-test was applied for comparison of treatments within sequence; ** Unpaired t-test was applied for comparison of treatments in periods; Sequence A: starting with insulin glargine (GLAR) and then switching to NPH insulin; Sequence B: starting with NPH insulin and then switching to insulin glargine (GLAR)