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Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: Results from the A1chieve observational study

Siddharth Shah, Alexey Zilov, Rachid Malek, Pradana Soewondo, Ole Bech and Leon Litwak

Diabetes Research and Clinical Practice, Issue 3, Volume 94, pages 364 - 370

Received 20 September 2011, Revised 10 October 2011, Accepted 13 October 2011, Published online Nov-2011


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3. Results

3.1. Metabolic control and hypoglycaemia

Data for insulin doses, blood glucose control, and body weight change are given in a separate manuscript (Home et al., submitted to Diabetes Res. Clin. Pract., this issue). Broadly, blood glucose control measures improved markedly in both insulin-naïve and prior insulin users, for groups starting insulin detemir, insulin aspart, or biphasic insulin aspart 30, and in all geographical regions (HbA1c change −1.5% to −2.5%). Similarly, reported hypoglycaemia rates were lower for the most part in all these subpopulations. Very little body weight change was observed during the study, some groups gaining <1.0 kg and some losing up to 1.0 kg.

3.2. Quality of life in the entire cohort

As measured by the visual analogue scale from the EQ-5D (on a scale of 0–100), reported QoL increased significantly by almost 14 points from 63.4 points at baseline to 77.2 points at 24 weeks (p < 0.001; Table 1). Across the other summary dimensions of quality of life there was an increase from baseline to Week 24 (Table 1). Large changes were seen for numbers reporting no problems in the descriptive QoL measures, including those relating to mental and physical functioning. By the end of the study over 75% of all people reported no problems with each of the dimensions of anxiety/depression, self-care, performing usual activities, pain or discomfort, and walking.

Table 1 Quality of life results for the entire cohort.

n Baseline 24 weeks Change p-value
QoL UK (scale 0–1) 43,170 0.67 (0.28) 0.83 (0.18) 0.16 (0.28) <0.001
EQ-5D VAS (scale 0–100) 41,749 63.4 (16.9) 77.2 (11.7) 13.8 (17.3) <0.001
Not anxious or depressed (%) 43,491 50.5 75.6 25.1 <0.001
No problems with self-care (%) 43,503 65.4 82.4 17.0 <0.001
No problems with performing my usual activities (%) 43,538 56.5 78.7 22.2 <0.001
No pain or discomfort (%) 43,552 46.3 71.2 24.9 <0.001
No problems walking (%) 43,598 59.0 84.2 25.2 <0.001

References in context

  • Across the other summary dimensions of quality of life there was an increase from baseline to Week 24 (Table 1).
    Go to context

  • Across the other summary dimensions of quality of life there was an increase from baseline to Week 24 (Table 1).
    Go to context

Data are utility value 0–1 (mean (SD)), visual analogue scale 0–100 (mean (SD)), and people scoring no problems in the five dimensions (%).

3.3. Quality of life for prior insulin-naïve or insulin-experienced populations

Baseline EQ-5D VAS score was similar for insulin-naïve and prior insulin-treated populations at baseline (62.8 and 64.8 out of 100; Table 2). Beginning insulin or changing insulin was associated with a significant increase in QoL score (+15.0 points and +11.1 points, respectively), resulting in a similar score at 24 weeks in the two populations (77.8 and 75.9 points). At baseline there were similar QoL scores across all dimensions for the two populations, apart from self-care, for which 62.6% of insulin-naïve people and 72.0% of insulin-experienced people reported no problems. During the study, QoL significantly increased in both groups, resulting in >80% of participants, irrespective of prior insulin status, reporting no problems with self-care. By 24 weeks, the biggest difference between the two groups was in the pain/discomfort dimension, with 73.3% of prior insulin-naïve people now reporting no problems, against 66.3% of prior insulin-experienced people.

Table 2 Quality of life results in those people who were insulin naïve or who were insulin experienced prior to study.

Insulin naïve, n = 44,872 Insulin experienced, n = 21,854
QoL UK (scale 0–1) n 30,291 12,879
Baseline 0.65 (0.29) 0.70 (0.25)
Week 24 0.83 (0.18) 0.82 (0.19)
Change 0.18 (0.29) 0.12 (0.26)
p <0.001 <0.001

EQ-5D VAS (0–100) n 29,248 12,501
Baseline 62.8 (17.0) 64.8 (16.6)
Week 24 77.8 (11.1) 75.9 (13.0)
Change 15.0 (17.4) 11.1 (16.9)
p <0.001 <0.001

Not anxious or depressed (%) n 30,513 12,978
Baseline 49.6 52.7
Week 24 76.8 72.5
Change 27.2 19.8
p <0.001 <0.001

No problems with self-care (%) n 30,518 12,985
Baseline 62.6 72.0
Week 24 81.7 84.3
Change 19.1 12.3
p <0.001 <0.001

No problems with performing my usual activities (%) n 30,548 12,990
Baseline 54.8 60.5
Week 24 78.9 78.3
Change 24.1 17.8
p <0.001 <0.001

No pain or discomfort (%) n 30,553 12,999
Baseline 46.1 46.6
Week 24 73.3 66.3
Change 27.2 19.7
p <0.001 <0.001

No problems walking (%) n 30,587 13,011
Baseline 57.9 61.4
Week 24 85.6 81.1
Change 27.7 19.7
p <0.001 <0.001

References in context

  • Baseline EQ-5D VAS score was similar for insulin-naïve and prior insulin-treated populations at baseline (62.8 and 64.8 out of 100; Table 2).
    Go to context

Data are utility value 0–1 (mean (SD)), visual analogue scale 0–100 (mean (SD)), and people scoring no problems in the five dimensions (%).

3.4. Quality of life results by treatment regimen

Quality of life scores were similar at baseline irrespective of the insulin analogue treatment begun (visual analogue scores of approximately 63 points; Table 3), with the exception of the people moving to the insulin aspart + basal regimen who on two measures appeared to experience better quality of life. Reported QoL then increased clinically and statistically significantly in users of all the insulin analogue regimens, such that by 24 weeks scores were very similar in all groups. Final EQ-5D VAS scores then clustered around 77 (out of 100) for all four regimens (Table 3).

Table 3 Quality of life results by new insulin regimen.

Biphasic insulin aspart 30, n = 40,917 Insulin detemir, n = 15,545 Insulin aspart alone, n = 3898 Insulin aspart + any basal, n = 4107
QoL UK (0–1) n 28,044 8998 2752 2269
Baseline 0.66 (0.29) 0.68 (0.26) 0.64 (0.29) 0.71 (0.25)
Week 24 0.83 (0.18) 0.83 (0.18) 0.84 (0.17) 0.82 (0.20)
Change 0.17 (0.29) 0.14 (0.26) 0.20 (0.30) 0.11 (0.25)
p <0.001 <0.001 <0.001 <0.001

EQ-5D VAS (0–100) n 26,964 8829 2676 2217
Baseline 63.5 (16.8) 62.6 (16.9) 63.4 (17.3) 63.8 (17.7)
Week 24 77.4 (11.3) 76.8 (12.6) 77.8 (11.1) 76.8 (12.8)
Change 13.8 (16.9) 14.3 (18.4) 14.4 (17.3) 12.9 (18.0)
p <0.001 <0.001 <0.001 <0.001

Not anxious or depressed (%) n 28,246 9072 2779 2283
Baseline 50.7 50.1 48.6 50.5
Week 24 76.2 74.5 78.1 69.9
Change 25.5 24.4 29.5 19.4
p <0.001 <0.001 <0.001 <0.001

No problems with self-care (%) n 28,229 9079 2794 2280
Baseline 63.1 71.2 60.3 74.3
Week 24 81.1 85.5 80.7 87.8
Change 18.0 14.3 20.4 13.5
p <0.001 <0.001 <0.001 <0.001

No problems with performing my usual activities (%) n 28,282 9059 2794 2283
Baseline 55.8 58.4 54.9 58.2
Week 24 78.4 79.4 79.3 79.1
Change 22.6 21.0 24.4 20.9
p <0.001 <0.001 <0.001 <0.001

No pain or discomfort (%) n 28,277 9088 2789 2281
Baseline 46.6 45.4 46.0 46.3
Week 24 72.3 68.0 76.9 65.2
Change 25.7 22.6 30.9 18.9
p <0.001 <0.001 <0.001 <0.001

No problems walking (%) n 28,307 9087 2799 2285
Baseline 58.4 60.6 56.2 62.1
Week 24 85.2 82.2 86.6 79.5
Change 26.8 21.6 30.4 17.4
p <0.001 <0.001 <0.001 <0.001

References in context

  • Final EQ-5D VAS scores then clustered around 77 (out of 100) for all four regimens (Table 3).
    Go to context

  • Final EQ-5D VAS scores then clustered around 77 (out of 100) for all four regimens (Table 3).
    Go to context

Data are utility value 0–1 (mean (SD)), visual analogue scale 0–100 (mean (SD)), and people scoring no problems in the five dimensions (%).

3.5. Quality of life results by region

There were some marked regional differences in reported QoL at baseline across the regions involved in the study, and these were consistent on all the four summary measures (Table 4). Russia and south Asia had the lowest QoL scores, with 55.1 and 55.7 (out of 100) on the EQ-5D VAS. East Asia, north Africa, the Middle East/Gulf and Latin America had similar baseline scores in the range of 62.6–68.4 (out of 100). China had the highest QoL score at baseline on all summary measures, with 75.9 (out of 100) on the VAS. Reported QoL increased clinically and statistically significantly across all regions by Week 24 (Table 4). The greatest increases were in those regions with the lowest QoL scores at baseline, such that by the end of study differences between regions were quite small. Thus by the end of the study EQ-5D QoL visual analogue scores ranged between 74.0, Russia, and 81.7, China (out of 100).

Table 4 Quality of life results by geographical region.

China, n = 11,020 South Asia, n = 22,447 East Asia, n = 10,032 North Africa, n = 4039 Middle East + Gulf, n = 14,976 Latin America, n = 1138 Russia, n = 3074
QoL UK (0–1) n 7845 17,438 8006 2949 3155 881 2896
Baseline 0.87 (0.19) 0.50 (0.27) 0.80 (0.21) 0.73 (0.22) 0.73 (0.22) 0.68 (0.25) 0.63 (0.20)
Week 24 0.89 (0.17) 0.80 (0.17) 0.88 (0.17) 0.82 (0.19) 0.81 (0.19) 0.81 (0.21) 0.79 (0.19)
Change 0.02 (0.22) 0.30 (0.29) 0.08 (0.22) 0.09 (0.23) 0.07 (0.23) 0.13 (0.24) 0.16 (0.21)
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

EQ-5D VAS (0–100) n 7710 16,371 7925 2959 3082 880 2822
Baseline 75.9 (13.7) 55.7 (13.8) 68.4 (15.3) 62.6 (17.9) 67.0 (15.7) 67.4 (18.8) 55.1 (17.2)
Week 24 81.7 (10.9) 76.2 (9.3) 77.0 (12.7) 74.4 (14.5) 76.4 (12.9) 79.9 (14.4) 74.0 (14.5)
Change 5.9 (15.0) 20.6 (15.8) 8.6 (16.5) 11.8 (18.3) 9.4 (16.1) 12.5 (17.8) 18.9 (17.7)
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

Not anxious or depressed (%) n 7883 17,536 8040 2976 3220 890 2946
Baseline 73.1 35.3 67.6 46.7 52.4 47.5 36.8
Week 24 76.3 76.7 81.4 64.3 67.8 70.1 72.4
Change 3.2 41.4 13.8 17.6 15.4 22.6 35.6
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

No problems with self-care (%) n 7897 17,588 8030 2980 3180 890 2938
Baseline 91.7 36.7 86.0 85.1 78.9 84.4 70.4
Week 24 91.5 71.0 92.0 91.1 85.3 90.3 86.5
Change −0.2 34.3 6.0 6.0 6.4 5.9 16.1
p 0.6881 <0.001 <0.001 <0.001 <0.001 0.0002 <0.001

No problems with performing my usual activities (%) n 7890 17,605 8037 2963 3222 888 2933
Baseline 87.5 33.5 74.3 72.3 65.3 65.0 34.3
Week 24 87.4 73.7 85.3 82.4 75.8 79.2 66.7
Change −0.1 40.2 11.0 10.1 10.5 14.2 32.4
p 0.9235 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

No pain or discomfort (%) n 7874 17,599 8044 2978 3219 893 2945
Baseline 75.3 32.5 57.7 44.4 42.7 37.4 27.7
Week 24 81.9 72.6 73.7 60.1 57.6 62.4 55.9
Change 6.6 40.1 16.0 15.7 14.9 25.0 28.2
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

No problems walking (%) n 7896 17,604 8043 2980 3227 894 2954
Baseline 87.7 36.7 78.3 76.0 68.0 57.9 35.2
Week 24 90.7 85.5 87.2 85.1 80.0 72.7 58.8
Change 3.0 48.8 8.9 9.1 12.0 14.8 23.6
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

References in context

  • Reported QoL increased clinically and statistically significantly across all regions by Week 24 (Table 4).
    Go to context

  • Reported QoL increased clinically and statistically significantly across all regions by Week 24 (Table 4).
    Go to context

Data are utility value 0–1 (mean (SD)), visual analogue scale 0–100 (mean (SD)), and people scoring no problems in the five dimensions (%). For details of which countries are in which region see Home et al. (submitted to Diabetes Res. Clin. Pract., this issue).

 
x

Table 1 Quality of life results for the entire cohort.

n Baseline 24 weeks Change p-value
QoL UK (scale 0–1) 43,170 0.67 (0.28) 0.83 (0.18) 0.16 (0.28) <0.001
EQ-5D VAS (scale 0–100) 41,749 63.4 (16.9) 77.2 (11.7) 13.8 (17.3) <0.001
Not anxious or depressed (%) 43,491 50.5 75.6 25.1 <0.001
No problems with self-care (%) 43,503 65.4 82.4 17.0 <0.001
No problems with performing my usual activities (%) 43,538 56.5 78.7 22.2 <0.001
No pain or discomfort (%) 43,552 46.3 71.2 24.9 <0.001
No problems walking (%) 43,598 59.0 84.2 25.2 <0.001

References in context

  • Across the other summary dimensions of quality of life there was an increase from baseline to Week 24 (Table 1).
    Go to context

  • Across the other summary dimensions of quality of life there was an increase from baseline to Week 24 (Table 1).
    Go to context

Data are utility value 0–1 (mean (SD)), visual analogue scale 0–100 (mean (SD)), and people scoring no problems in the five dimensions (%).

Table 2 Quality of life results in those people who were insulin naïve or who were insulin experienced prior to study.

Insulin naïve, n = 44,872 Insulin experienced, n = 21,854
QoL UK (scale 0–1) n 30,291 12,879
Baseline 0.65 (0.29) 0.70 (0.25)
Week 24 0.83 (0.18) 0.82 (0.19)
Change 0.18 (0.29) 0.12 (0.26)
p <0.001 <0.001

EQ-5D VAS (0–100) n 29,248 12,501
Baseline 62.8 (17.0) 64.8 (16.6)
Week 24 77.8 (11.1) 75.9 (13.0)
Change 15.0 (17.4) 11.1 (16.9)
p <0.001 <0.001

Not anxious or depressed (%) n 30,513 12,978
Baseline 49.6 52.7
Week 24 76.8 72.5
Change 27.2 19.8
p <0.001 <0.001

No problems with self-care (%) n 30,518 12,985
Baseline 62.6 72.0
Week 24 81.7 84.3
Change 19.1 12.3
p <0.001 <0.001

No problems with performing my usual activities (%) n 30,548 12,990
Baseline 54.8 60.5
Week 24 78.9 78.3
Change 24.1 17.8
p <0.001 <0.001

No pain or discomfort (%) n 30,553 12,999
Baseline 46.1 46.6
Week 24 73.3 66.3
Change 27.2 19.7
p <0.001 <0.001

No problems walking (%) n 30,587 13,011
Baseline 57.9 61.4
Week 24 85.6 81.1
Change 27.7 19.7
p <0.001 <0.001

References in context

  • Baseline EQ-5D VAS score was similar for insulin-naïve and prior insulin-treated populations at baseline (62.8 and 64.8 out of 100; Table 2).
    Go to context

Data are utility value 0–1 (mean (SD)), visual analogue scale 0–100 (mean (SD)), and people scoring no problems in the five dimensions (%).

Table 3 Quality of life results by new insulin regimen.

Biphasic insulin aspart 30, n = 40,917 Insulin detemir, n = 15,545 Insulin aspart alone, n = 3898 Insulin aspart + any basal, n = 4107
QoL UK (0–1) n 28,044 8998 2752 2269
Baseline 0.66 (0.29) 0.68 (0.26) 0.64 (0.29) 0.71 (0.25)
Week 24 0.83 (0.18) 0.83 (0.18) 0.84 (0.17) 0.82 (0.20)
Change 0.17 (0.29) 0.14 (0.26) 0.20 (0.30) 0.11 (0.25)
p <0.001 <0.001 <0.001 <0.001

EQ-5D VAS (0–100) n 26,964 8829 2676 2217
Baseline 63.5 (16.8) 62.6 (16.9) 63.4 (17.3) 63.8 (17.7)
Week 24 77.4 (11.3) 76.8 (12.6) 77.8 (11.1) 76.8 (12.8)
Change 13.8 (16.9) 14.3 (18.4) 14.4 (17.3) 12.9 (18.0)
p <0.001 <0.001 <0.001 <0.001

Not anxious or depressed (%) n 28,246 9072 2779 2283
Baseline 50.7 50.1 48.6 50.5
Week 24 76.2 74.5 78.1 69.9
Change 25.5 24.4 29.5 19.4
p <0.001 <0.001 <0.001 <0.001

No problems with self-care (%) n 28,229 9079 2794 2280
Baseline 63.1 71.2 60.3 74.3
Week 24 81.1 85.5 80.7 87.8
Change 18.0 14.3 20.4 13.5
p <0.001 <0.001 <0.001 <0.001

No problems with performing my usual activities (%) n 28,282 9059 2794 2283
Baseline 55.8 58.4 54.9 58.2
Week 24 78.4 79.4 79.3 79.1
Change 22.6 21.0 24.4 20.9
p <0.001 <0.001 <0.001 <0.001

No pain or discomfort (%) n 28,277 9088 2789 2281
Baseline 46.6 45.4 46.0 46.3
Week 24 72.3 68.0 76.9 65.2
Change 25.7 22.6 30.9 18.9
p <0.001 <0.001 <0.001 <0.001

No problems walking (%) n 28,307 9087 2799 2285
Baseline 58.4 60.6 56.2 62.1
Week 24 85.2 82.2 86.6 79.5
Change 26.8 21.6 30.4 17.4
p <0.001 <0.001 <0.001 <0.001

References in context

  • Final EQ-5D VAS scores then clustered around 77 (out of 100) for all four regimens (Table 3).
    Go to context

  • Final EQ-5D VAS scores then clustered around 77 (out of 100) for all four regimens (Table 3).
    Go to context

Data are utility value 0–1 (mean (SD)), visual analogue scale 0–100 (mean (SD)), and people scoring no problems in the five dimensions (%).

Table 4 Quality of life results by geographical region.

China, n = 11,020 South Asia, n = 22,447 East Asia, n = 10,032 North Africa, n = 4039 Middle East + Gulf, n = 14,976 Latin America, n = 1138 Russia, n = 3074
QoL UK (0–1) n 7845 17,438 8006 2949 3155 881 2896
Baseline 0.87 (0.19) 0.50 (0.27) 0.80 (0.21) 0.73 (0.22) 0.73 (0.22) 0.68 (0.25) 0.63 (0.20)
Week 24 0.89 (0.17) 0.80 (0.17) 0.88 (0.17) 0.82 (0.19) 0.81 (0.19) 0.81 (0.21) 0.79 (0.19)
Change 0.02 (0.22) 0.30 (0.29) 0.08 (0.22) 0.09 (0.23) 0.07 (0.23) 0.13 (0.24) 0.16 (0.21)
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

EQ-5D VAS (0–100) n 7710 16,371 7925 2959 3082 880 2822
Baseline 75.9 (13.7) 55.7 (13.8) 68.4 (15.3) 62.6 (17.9) 67.0 (15.7) 67.4 (18.8) 55.1 (17.2)
Week 24 81.7 (10.9) 76.2 (9.3) 77.0 (12.7) 74.4 (14.5) 76.4 (12.9) 79.9 (14.4) 74.0 (14.5)
Change 5.9 (15.0) 20.6 (15.8) 8.6 (16.5) 11.8 (18.3) 9.4 (16.1) 12.5 (17.8) 18.9 (17.7)
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

Not anxious or depressed (%) n 7883 17,536 8040 2976 3220 890 2946
Baseline 73.1 35.3 67.6 46.7 52.4 47.5 36.8
Week 24 76.3 76.7 81.4 64.3 67.8 70.1 72.4
Change 3.2 41.4 13.8 17.6 15.4 22.6 35.6
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

No problems with self-care (%) n 7897 17,588 8030 2980 3180 890 2938
Baseline 91.7 36.7 86.0 85.1 78.9 84.4 70.4
Week 24 91.5 71.0 92.0 91.1 85.3 90.3 86.5
Change −0.2 34.3 6.0 6.0 6.4 5.9 16.1
p 0.6881 <0.001 <0.001 <0.001 <0.001 0.0002 <0.001

No problems with performing my usual activities (%) n 7890 17,605 8037 2963 3222 888 2933
Baseline 87.5 33.5 74.3 72.3 65.3 65.0 34.3
Week 24 87.4 73.7 85.3 82.4 75.8 79.2 66.7
Change −0.1 40.2 11.0 10.1 10.5 14.2 32.4
p 0.9235 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

No pain or discomfort (%) n 7874 17,599 8044 2978 3219 893 2945
Baseline 75.3 32.5 57.7 44.4 42.7 37.4 27.7
Week 24 81.9 72.6 73.7 60.1 57.6 62.4 55.9
Change 6.6 40.1 16.0 15.7 14.9 25.0 28.2
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

No problems walking (%) n 7896 17,604 8043 2980 3227 894 2954
Baseline 87.7 36.7 78.3 76.0 68.0 57.9 35.2
Week 24 90.7 85.5 87.2 85.1 80.0 72.7 58.8
Change 3.0 48.8 8.9 9.1 12.0 14.8 23.6
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

References in context

  • Reported QoL increased clinically and statistically significantly across all regions by Week 24 (Table 4).
    Go to context

  • Reported QoL increased clinically and statistically significantly across all regions by Week 24 (Table 4).
    Go to context

Data are utility value 0–1 (mean (SD)), visual analogue scale 0–100 (mean (SD)), and people scoring no problems in the five dimensions (%). For details of which countries are in which region see Home et al. (submitted to Diabetes Res. Clin. Pract., this issue).


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