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 |