Back to list

An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: The A1chieve study

Philip Home, Nabil El Naggar, Mohammed Khamseh, Guillermo Gonzalez-Galvez, Chunduo Shen, Praful Chakkarwar and Wenying Yang

Diabetes Research and Clinical Practice, Issue 3, Volume 94, pages 352 - 363

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


Article view:

Table 1 Participant numbers and characteristics for the entire cohort and by pre-study therapy.

Entire cohort Insulin-naϊve Prior insulin users
n (%) 66,726 (100) 44,872 (67.2) 21,854 (32.8)
Sex, M/F (%) 55.6/44.4 57.3/42.7 51.9/48.1
Age (years) 54.0 (12.0) 53.2 (11.6) 55.6 (12.5)
Body weight (kg) 72.9 (15.0) 71.7 (14.4) 75.3 (15.9)
BMI (kg/m2) 27.1 (5.0) 26.7 (4.7) 27.9 (5.5)
Diabetes duration (years) 8.0 (6.2) 6.6 (5.4) 10.8 (6.8)
HbA1c (mmol/mol) 80 (19) 80 (19) 79 (20)
HbA1c (%) 9.5 (1.7) 9.5 (1.7) 9.4 (1.8)
Prior OGLDs, n (%)
 Metformin 44,801 (82.0) 32,006 (82.4) 12,795 (81.1)
 Sulfonylureas 37,086 (67.9) 29,645 (76.3) 7441 (47.2)
 Thiazolidinediones 10,578 (19.4) 8087 (20.8) 2491 (15.8)
 One/two/>two 16,193 (29.6)/27,466 (50.3)/10,981 (20.1) 8519 (21.9)/21,372 (55.0)/8971 (23.1) 7674 (48.6)/6094 (38.6)/2010 (12.7)
Geographic region, n (%)
 China 11,020 (100) 8206 (74.4) 2814 (25.6)
 East Asia 10,032 (100) 6594 (65.7) 3438 (34.3)
 Latin America 1138 (100) 636 (55.9) 502 (44.1)
 Middle East + Gulf 14,976 (100) 7501 (50.1) 7475 (49.9)
 North Africa 4039 (100) 1969 (48.7) 2070 (51.3)
 Russia 3074 (100) 1899 (61.8) 1175 (38.2)
 South Asia 22,447 (100) 18,067 (80.5) 4380 (19.5)

References in context

  • Use of OGLDs prior to beginning insulin analogues is given in Table 1.
    Go to context

  • Use of OGLDs prior to beginning insulin analogues is given in Table 1.
    Go to context

  • The regional distribution of participants is given in Table 1.
    Go to context

Data are n (%), %, or mean (SD).

Table 2 Glucose control and body weight for the entire cohort and by pre-study therapy at baseline and after 24 weeks of insulin analogue therapy.

Entire cohort Insulin-naϊve Prior insulin users
Baseline 24 weeks Baseline 24 weeks Baseline 24 weeks
HbA1c, mmol/mol/% n 44,661 30,369 14,292
Baseline/24 weeks 80 (19)/9.5 (1.7) 57 (12)/7.4 (1.1) 80 (19)/9.5 (1.7) 57 (11)/7.4 (1.0) 79 (20)/9.4 (1.8) 60 (13)/7.6 (1.2)
Change, p −23 (19)/−2.1 (1.7), <0.001 −23 (19)/−2.2 (1.7), <0.001 −19 (19)/−1.8 (1.7), <0.001
FPG, mmol/L n 48,191 33,087 15,104
Baseline/24 weeks 10.9 (3.5) 7.1 (1.9) 11.2 (3.4) 7.1 (1.8) 10.5 (3.7) 7.2 (2.2)
Change, p −3.8 (3.5), <0.001 −4.1 (3.3), <0.001 −3.2 (3.8), <0.001
PPPG, mmol/L n 33,742 23,334 10,408
Baseline/24 weeks 15.1 (4.4) 9.7 (2.9) 15.5 (4.3) 9.8 (2.9) 14.2 (4.5) 9.7 (3.0)
Change, p −5.4 (4.5), <0.001 −5.8 (4.4), <0.001 −4.5 (4.6), <0.001
Weight, kg n 50,059 33,716 16,343
Baseline/24 weeks 73.3 (14.8) 73.3 (14.1) 72.1 (14.3) 72.2 (13.5) 75.7 (15.7) 75.7 (15.1)
Change, p 0.1 (3.7), <0.001 0.1 (3.7), <0.001 −0.0 (3.6), 0.081
SBP, mmHg n 45,285 29,595 15,690
Baseline/24 weeks 134.2 (17.8) 127.9 (13.5) 134.0 (17.7) 127.3 (13.3) 134.7 (18.0) 129.0 (13.7)
Change, p −6.3 (17.1), <0.001 −6.6 (17.4), <0.001 −5.7 (16.6), <0.001
Total cholesterol, mmol/L n 20,293 11,994 8299
Baseline/24 weeks 5.3 (1.3) 4.8 (1.0) 5.4 (1.3) 4.8 (1.0) 5.2 (1.3) 4.8 (1.0)
Change, p −0.5 (1.2), <0.001 −0.6 (1.2), <0.001 −0.4 (1.2), <0.001
Triglycerides, mmol/L n 19,856 11,672 8184
Baseline/24 weeks 2.1 (1.1) 1.8 (0.7) 2.1 (1.1) 1.7 (0.7) 2.0 (1.1) 1.8 (0.7)
Change, p −0.3 (0.9), <0.001 −0.4 (1.0), <0.001 −0.3 (0.9), <0.001
HDL cholesterol, mmol/L n 17,306 10,189 7117
Baseline/24 weeks 1.1 (0.4) 1.2 (0.4) 1.2 (0.4) 1.2 (0.4) 1.1 (0.4) 1.2 (0.4)
Change, p 0.1 (0.4), <0.001 0.1 (0.4), <0.001 0.0 (0.4), <0.001
LDL cholesterol, mmol/L n 17,494 10,304 7190
Baseline/24 weeks 3.1 (1.0) 2.8 (0.9) 3.2 (1.0) 2.7 (0.9) 3.1 (1.1) 2.8 (0.9)
Change, p −0.4 (1.0), <0.001 −0.4 (1.0), <0.001 −0.3 (1.1), <0.001
Hypoglycaemia (event per person-year/percent with event)
 Overall Baseline/24 weeks 3.11/8.9 1.61/5.9 1.07/4.2 1.19/4.4 7.31/18.4 2.48/8.9
ap <0.0001 0.1713 <0.0001
 Minor Baseline/24 weeks 2.79/8.5 1.60/5.8 0.98/4.0 1.18/4.4 6.50/17.6 2.47/8.9
ap <0.0001 0.0056 <0.0001
 Nocturnal Baseline/24 weeks 0.93/4.0 0.36/1.8 0.28/1.6 0.26/1.3 2.24/9.0 0.58/2.9
ap <0.0001 0.0012 <0.0001
 Major Baseline/24 weeks 0.33/1.5 0.01/0.03 0.09/0.5 0.00/0.02 0.81/3.5 0.01/0.07
ap <0.0001 <0.0001 <0.0001

References in context

  • Blood glucose control improved markedly and statistically significantly between baseline and 6 months in the whole cohort (Table 2: HbA1c −23mmol/mol [−2.1%], FPG −3.8mmol/L, PPPG −5.4mmol/L), and was clinically similar in the insulin-naïve and prior insulin use groups, although numerically larger in the insulin-naïve group (Table 2).
    Go to context

  • Blood glucose control improved markedly and statistically significantly between baseline and 6 months in the whole cohort (Table 2: HbA1c −23mmol/mol [−2.1%], FPG −3.8mmol/L, PPPG −5.4mmol/L), and was clinically similar in the insulin-naïve and prior insulin use groups, although numerically larger in the insulin-naïve group (Table 2).
    Go to context

  • The reported rate of all hypoglycaemic episodes in the 4 weeks before study visits differed for the insulin-naϊve and prior insulin use cohorts (Table 2).
    Go to context

  • On pre-study therapy, major hypoglycaemic episodes were more frequent in the prior insulin use population (0.81 events/person-year) than in the insulin-naïve population (0.09 events/person-year at baseline), and reported incidence in the prior insulin users reduced to <0.01 events/person-year after 24 weeks (Table 2, people affected p<0.0001).
    Go to context

  • For both the entire cohort and the insulin-naïve population, mean body weight change over 24 weeks was statistically but not clinically significant (Table 2, mean +0.1kg, p<0.001).
    Go to context

  • Results were similar for the insulin-naϊve and prior insulin use populations (Table 2).
    Go to context

  • Results were similar for the insulin-naϊve and prior insulin use populations (Table 2).
    Go to context

  • Although people previously managed on lifestyle therapy alone or with OGLDs seemingly experienced greater improvements in glucose control than prior insulin users (Table 2), their baseline levels tended to be higher.
    Go to context

Data are mean (SD), n or incidence.

a p-value is for difference in percent of people with at least one event.

Table 3 Baseline and 24-week data for effectiveness and safety outcomes by insulin analogue regimen started.

Insulin-naïve Prior insulin users
Biphasic aspart Insulin detemir Insulin aspart alone Insulin aspart + basal Biphasic aspart Insulin detemir Insulin aspart alone Insulin aspart + basal
Insulin dose, U/day n 27,591 12,078 2751 1593 13,318 3467 1145 2512
Pre-study 40.5 (21.3) 31.8 (19.7) 35.1 (18.9) 51.8 (26.1)
Baseline 28.9 (12.4) 18.0 (9.9) 27.7 (12.0) 43.0 (17.7) 40.6 (18.7) 26.7 (15.1) 30.0 (15.9) 56.6 (22.9)
Week 24 32.6 (16.1) 26.7 (15.1) 27.7 (12.7) 47.0 (23.0) 45.6 (21.8) 34.4 (20.1) 36.9 (19.9) 63.3 (27.9)
HbA1c, mmol/mol/% n 18,459 8459 1764 1127 8574 2122 709 1869
Baseline 80 (19)/9.5 (1.7) 80 (18)/9.5 (1.6) 81 (20)/9.6 (1.8) 87 (23)/10.1 (2.1) 79 (20)/9.4 (1.8) 78 (19)/9.3 (1.7) 77 (21)/9.2 (1.9) 79 (20)/9.4 (1.8)
Week 24 56 (11)/7.3 (1.0) 57 (12)/7.4 (1.1) 56 (11)/7.3 (1.0) 56 (13)/7.3 (1.2) 58 (13)/7.5 (1.2) 60 (14)/7.6 (1.3) 58 (13)/7.5 (1.2) 58 (13)/7.5 (1.2)
Change, p −24 (19)/−2.2 (1.7) <0.001 −23 (18)/−2.1 (1.6) <0.001 −25 (20)/−2.3 (1.8) <0.001 −51 (22)/−2.8 (2.0) <0.001 −20 (19)/−1.8 (1.7) <0.001 − 38 (19)/−1.6 (1.7) <0.001 − 19 (21)/−1.7 (1.9) <0.001 −22 (19)/−2.0 (1.7) <0.001
FPG, mmol/L n 20,678 8560 2029 1221 9206 2182 774 1905
Baseline 11.1 (3.4) 11.2 (3.2) 11.4 (4.0) 11.9 (4.1) 10.6 (3.8) 9.9 (3.3) 10.1 (3.6) 10.3 (3.5)
Week 24 7.1 (1.8) 7.0 (1.9) 7.6 (2.2) 7.0 (1.7) 7.3 (2.2) 7.3 (2.3) 7.3 (2.2) 7.0 (1.9)
Change, p −4.0 (3.3) <0.001 −4.2 (3.2) <0.001 −3.8 (3.3) <0.001 −4.9 (4.2) <0.001 −3.3 (3.9) <0.001 −2.6 (3.5) <0.001 −2.7 (3.6) <0.001 −3.3 (3.6) <0.001
PPPG, mmol/L n 14,642 5757 1559 917 6169 1391 599 1447
Baseline 15.6 (4.2) 15.0 (4.2) 16.5 (5.0) 15.7 (5.0) 14.3 (4.5) 13.8 (4.3) 13.9 (4.6) 13.8 (4.5)
Week 24 9.8 (2.8) 9.5 (2.8) 10.6 (3.6) 9.0 (2.3) 9.8 (3.0) 9.9 (3.2) 10.3 (3.2) 8.8 (2.3)
Change, p −5.8 (4.4) <0.001 −5.5 (4.2) <0.001 −5.8 (4.3) <0.001 −6.7 (5.0) <0.001 −4.5 (4.5) <0.001 −3.8 (4.3) <0.001 −3.6 (4.3) <0.001 −4.9 (4.5) <0.001
Body weight, kg n 20,446 9336 2052 1273 9748 2598 862 2030
Baseline 70.2 (12.6) 76.5 (16.3) 68.2 (12.0) 74.7 (16.9) 74.7 (14.9) 76.7 (16.3) 70.1 (14.0) 79.7 (17.1)
Week 24 70.5 (12.0) 76.2 (15.4) 68.4 (11.4) 74.6 (15.5) 74.9 (14.5) 76.0 (15.7) 70.2 (13.4) 79.4 (16.0)
Change, p 0.3 (3.5) <0.001 −0.3 (4.0) <0.001 0.2 (2.8) 0.007 −0.0 (4.2) 0.687 0.2 (3.6) <0.001 −0.7 (3.6) <0.001 −0.0 (4.2) 0.687 −0.3 (3.7) <0.001
SBP, mmHg n 17,025 9077 1660 1268 9222 2543 765 2062
Baseline 134.1 (17.8) 133.3 (16.7) 135.8 (20.9) 133.7 (18.1) 135.4 (18.2) 133.0 (16.9) 133.6 (17.4) 133.7 (17.9)
Week 24 126.9 (12.2) 127.9 (15.2) 127.1 (12.5) 127.6 (12.6) 129.3 (13.8) 128.4 (13.7) 127.6 (14.8) 129.0 (13.1)
Change, p −7.1 (17.0) <0.001 −5.4 (17.7) <0.001 −8.7 (19.6) <0.001 −6.1 (15.7) <0.001 −6.1 (17.0) <0.001 −4.5 (15.6) <0.001 −6.0 (16.1) <0.001 −4.8 (15.3) <0.001
Total cholesterol, mmol/L n 6111 4529 457 618 4900 1262 301 1239
Baseline 5.4 (1.2) 5.3 (1.2) 5.1 (1.3) 5.6 (1.5) 5.2 (1.3) 5.2 (1.4) 5.2 (1.3) 5.3 (1.3)
Week 24 4.8 (1.0) 4.8 (0.9) 4.6 (1.0) 4.9 (1.0) 4.8 (1.0) 4.8 (1.0) 4.7 (1.0) 4.9 (1.0)
Change, p −0.6 (1.2) <0.001 −0.6 (1.1) <0.001 −0.5 (1.3) <0.001 −0.7 (1.3) <0.001 −0.4 (1.2) <0.001 −0.4 (1.1) <0.001 −0.5 (1.1) <0.001 −0.4 (1.1) <0.001
Trigylceride, mmol/L n 6086 4251 471 582 4910 1162 303 1190
Baseline 2.1 (1.1) 2.1 (1.0) 2.0 (1.1) 2.2 (1.2) 2.1 (1.1) 1.9 (1.0) 2.0 (1.0) 2.0 (1.0)
Week 24 1.8 (0.7) 1.7 (0.7) 1.8 (0.8) 1.7 (0.7) 1.8 (0.7) 1.7 (0.8) 1.8 (0.7) 1.8 (0.7)
Change, p −0.4 (1.0) <0.001 −0.4 (0.9) <0.001 −0.3 (1.0) <0.001 −0.5 (1.0) <0.001 −0.3 (1.0) <0.001 −0.2 (0.9) <0.001 −0.2 (0.7) <0.001 −0.3 (0.9) <0.001
HDL cholesterol, mmol/L n 5589 3418 439 488 4373 970 264 936
Baseline 1.2 (0.4) 1.1 (0.4) 1.1 (0.3) 1.2 (0.5) 1.1 (0.4) 1.1 (0.4) 1.2 (0.4) 1.1 (0.5)
Week 24 1.3 (0.4) 1.2 (0.3) 1.2 (0.4) 1.3 (0.4) 1.2 (0.4) 1.2 (0.4) 1.2 (0.3) 1.2 (0.4)
Change, p 0.1 (0.4) <0.001 0.0 (0.3) <0.001 0.1 (0.4) <0.001 0.1 (0.4) <0.001 0.0 (0.4) <0.001 0.0 (0.4) 0.012 0.0 (0.3) 0.826 0.1 (0.4) <0.001
LDL cholesterol, mmol/L n 5648 3459 447 495 4437 969 272 927
Baseline 3.2 (1.0) 3.1 (1.0) 3.0 (1.0) 3.3 (1.1) 3.1 (1.1) 3.0 (1.0) 3.1 (1.0) 3.0 (1.0)
Week 24 2.8 (0.9) 2.7 (0.8) 2.8 (1.0) 2.8 (0.8) 2.8 (0.9) 2.7 (0.9) 2.8 (0.9) 2.7 (0.9)
Change, p −0.4 (1.0) <0.001 −0.4 (1.0) <0.001 −0.3 (1.0) <0.001 −0.5 (1.0) <0.001 −0.3 (1.1) <0.001 −0.3 (0.9) <0.001 −0.3 (1.1) <0.001 −0.3 (1.0) <0.001
Hypoglycaemia (event per person-year/percent with event)
 Overall Baseline 0.95/4.0 1.14/4.1 1.59/5.9 1.66/5.4 5.49/15.4 8.30/20.7 6.95/18.1 14.50/29.0
Week 24 1.04/4.2 1.33/4.4 0.88/3.0 2.95/8.7 2.35/8.8 1.83/6.4 1.82/7.4 4.08/12.9
ap 0.1886 0.1982 <0.0001 0.0004 <0.0001 <0.0001 <0.0001 <0.0001
 Minor Baseline 0.86/3.8 1.06/3.9 1.46/5.6 1.50/5.4 4.96/14.9 7.42/19.7 6.02/16.8 13.10/27.9
Week 24 1.04/4.2 1.33/4.4 0.88/3.0 2.95/8.7 2.34/8.7 1.83/6.4 1.82/7.4 4.08/12.8
ap 0.0113 0.0669 <0.0001 0.0004 <0.0001 <0.0001 <0.0001 <0.0001
 Nocturnal Baseline 0.27/1.4 0.27/1.5 0.46/2.8 0.37/1.8 1.60/6.9 2.79/11.2 2.00/8.7 4.54/15.1
Week 24 0.20/1.1 0.38/1.7 0.15/0.9 0.42/2.4 0.55/2.9 0.47/1.9 0.33/1.8 0.95/5.0
ap 0.0007 0.3078 <0.0001 0.3083 <0.0001 <0.0001 <0.0001 <0.0001
 Major Baseline 0.09/0.5 0.07/0.4 0.13/0.08 0.16/0.6 0.53/2.6 0.88/3.6 0.93/4.0 1.42/6.2
Week 24 0.00/0.02 0.00/0.01 0.00/0.0 0.00/0.0 0.02/0.07 0.01/0.07 0.00/0.0 0.001/0.05
ap <0.0001 <0.0001 <0.0001 0.0022 <0.0001 <0.0001 <0.0001 <0.0001

References in context

  • In the insulin-experienced population, pre-study insulin dose appeared to be lower in the population starting insulin detemir, which seemingly accounts for this group having the lowest daily dose at 24 weeks (Table 3).
    Go to context

  • In the insulin-experienced population, pre-study insulin dose appeared to be lower in the population starting insulin detemir, which seemingly accounts for this group having the lowest daily dose at 24 weeks (Table 3).
    Go to context

  • This pattern was echoed for both FPG and PPPG control, where, again, there was no obvious differential effect of insulin type between these pre- and post-meal measures, although, again, the biggest improvements were in the insulin-naϊve populations (Table 3).
    Go to context

  • This pattern was echoed for both FPG and PPPG control, where, again, there was no obvious differential effect of insulin type between these pre- and post-meal measures, although, again, the biggest improvements were in the insulin-naϊve populations (Table 3).
    Go to context

  • In general, the changes in nocturnal hypoglycaemia tended to echo those of the overall change (Table 3).
    Go to context

  • In general, the changes in nocturnal hypoglycaemia tended to echo those of the overall change (Table 3).
    Go to context

  • The same was true of LDL cholesterol, while HDL cholesterol was unchanged with all regimens in both populations (Table 3).
    Go to context

  • The same was true of LDL cholesterol, while HDL cholesterol was unchanged with all regimens in both populations (Table 3).
    Go to context

  • The same was true of LDL cholesterol, while HDL cholesterol was unchanged with all regimens in both populations (Table 3).
    Go to context

Data are mean (SD) unless otherwise stated. A small number of people using other insulin regimens (n = 2146) could not be included in the above classifications.

a p-value is for difference in percent of people with at least one event.

Table 4 Glucose control and body weight by global region at baseline and after 24 weeks of insulin analogue therapy.

China South Asia East Asia North Africa Middle East + Gulf Latin America Russia
Dose, U/day n 11,013 22,415 10,031 4033 14,896 1136 3074
Baseline 31.0 (12.5) 26.4 (11.5) 27.1 (16.6) 32.2 (21.0) 42.3 (23.4) 31.8 (20.9) 29.5 (18.5)
Week 24 32.0 (12.8) 26.1 (11.5) 33.3 (18.0) 41.8 (23.4) 52.7 (25.0) 41.3 (24.1) 44.4 (21.7)
HbA1c, mmol/mol/% n 5784 17,111 4167 2601 11,618 573 2807
Baseline 80 (25)/9.5 (2.3) 78 (16)/9.3 (1.4) 83 (21)/9.7 (1.9) 80 (20)/9.5 (1.8) 81 (19)/9.6 (1.7) 85 (24)/9.9 (2.2) 81 (19)/9.6 (1.7)
Week 24 53 (11)/7.0 (1.0) 57 (10)/7.4 (0.9) 62 (16)/7.8 (1.4) 63 (16)/7.9 (1.4) 57 (12)/7.4 (1.1) 62 (16)/7.8 (1.4) 57 (11)/7.4 (1.0)
Change −28 (24)/−2.5 (2.2) −21 (16)/−1.9 (1.4) −22 (22)/−2.0 (2.0) −18 (21)/−1.6 (1.9) −24 (18)/−2.2 (1.6) − 24 (24)/−2.2 (2.2) −24 (17)/−2.2 (1.5)
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
FPG, mmol/L n 8281 17,287 5225 2904 10,737 738 3019
Baseline 10.3 (3.6) 10.9 (3.0) 11.5 (4.3) 11.4 (4.2) 11.3 (3.7) 11.6 (4.6) 10.4 (2.7)
Week 24 6.8 (1.3) 7.3 (1.9) 7.3 (2.4) 7.9 (2.8) 7.0 (1.9) 7.2 (2.4) 6.6 (1.3)
Change −3.5 (3.7) −3.6 (2.7) −4.2 (4.5) −3.5 (4.7) −4.3 (3.6) −4.4 (4.7) −3.8 (2.7)
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
PPPG, mmol/L n 6251 12,570 2987 1683 7588 146 2517
Baseline 14.2 (4.9) 15.9 (3.7) 15.8 (5.0) 14.8 (4.7) 15.4 (4.6) 15.3 (5.7) 12.1 (3.1)
Week 24 8.8 (1.9) 10.8 (3.2) 9.6 (3.3) 10.4 (3.5) 9.2 (2.4) 9.0 (2.5) 8.0 (1.4)
Change −5.4 (5.0) −5.1 (3.8) −6.1 (5.5) −4.4 (5.5) −6.2 (4.5) −6.3 (5.7) −4.2 (3.0)
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
Body weight, kg n 7815 16,869 6831 3202 11,357 964 3021
Baseline 68.6 (11.5) 68.9 (10.2) 64.0 (12.3) 75.4 (13.3) 84.4 (15.4) 77.9 (16.9) 85.2 (15.6)
Week 24 68.9 (11.0) 68.9 (9.7) 64.7 (11.7) 76.2 (12.8) 84.0 (14.4) 78.1 (16.4) 84.4 (14.9)
Change 0.3 (3.1) 0.0 (3.2) 0.7 (3.8) 0.9 (3.9) −0.4 (4.4) 0.2 (4.1) −0.8 (3.3)
p <0.001 0.569 <0.001 <0.001 <0.001 0.083 <0.001
SBP, mmHg n 6414 12,739 6784 3070 12,295 954 3029
Baseline 132.4 (16.8) 135.3 (18.4) 130.1 (17.3) 133.1 (18.2) 134.9 (17.3) 130.0 (16.9) 142.4 (17.1)
Week 24 128.2 (12.4) 126.5 (11.1) 125.5 (14.9) 131.0 (19.2) 128.5 (13.2) 127.5 (14.0) 133.4 (12.3)
Change, p −4.2 (15.8) <0.001 −8.8 (16.9) <0.001 −4.6 (18.0) <0.001 −2.1 (20.9) <0.001 −6.4 (16.5) <0.001 −2.6 (17.7) <0.001 −9.0 (14.1) <0.001
Total cholesterol, mmol/L n 3589 1417 2180 1532 8213 500 2862
Baseline 5.1 (1.2) 5.1 (0.9) 5.2 (1.5) 4.7 (1.2) 5.3 (1.2) 5.6 (1.6) 6.0 (1.3)
Week 24 4.6 (1.1) 4.7 (0.8) 4.6 (1.0) 4.5 (1.0) 4.7 (0.8) 5.1 (1.0) 5.5 (1.0)
Change, p −0.5 (1.3) <0.001 −0.4 (0.6) <0.001 −0.6 (1.4) <0.001 −0.2 (1.2) <0.001 −0.6 (1.1) <0.001 −0.5 (1.5) <0.001 −0.5 (1.0) <0.001
Triglycerides, mmol/L n 3532 2264 1809 1586 8171 420 2074
Baseline 2.1 (1.3) 2.1 (0.8) 2.0 (1.1) 1.7 (0.9) 2.2 (1.0) 2.4 (1.3) 2.1 (1.0)
Week 24 1.7 (0.8) 1.8 (0.6) 1.6 (0.8) 1.5 (0.7) 1.8 (0.7) 1.9 (0.9) 1.7 (0.8)
Change, p −0.3 (1.2) <0.001 −0.3 (0.6) <0.001 −0.3 (1.0) <0.001 −0.1 (0.9) <0.001 −0.4 (0.9) <0.001 −0.5 (1.3) <0.001 −0.3 (0.8) <0.001
HDL cholesterol, mmol/L n 3255 2327 1565 1044 7447 344 1324
Baseline 1.2 (0.5) 1.0 (0.2) 1.2 (0.4) 1.1 (0.4) 1.1 (0.3) 1.1 (0.4) 1.4 (0.6)
Week 24 1.4 (0.5) 1.0 (0.3) 1.3 (0.3) 1.1 (0.4) 1.1 (0.3) 1.1 (0.3) 1.5 (0.5)
Change, p 0.1 (0.5) <0.001 −0.0 (0.3) 0.783 0.1 (0.4) <0.001 0.0 (0.5) 0.046 0.0 (0.3) <0.001 0.1 (0.3) <0.001 0.1 (0.5) <0.001
LDL cholesterol, mmol/L n 3313 2309 1567 1007 7630 322 1346
Baseline 3.1 (1.1) 3.1 (0.9) 3.2 (1.2) 2.9 (1.2) 3.2 (1.0) 3.1 (1.1) 3.3 (1.1)
Week 24 2.7 (1.0) 2.8 (0.7) 2.8 (0.9) 2.7 (1.1) 2.7 (0.8) 2.9 (0.8) 2.9 (1.0)
Change, p −0.4 (1.1) <0.001 −0.3 (0.7) <0.001 −0.4 (1.2) <0.001 −0.1 (1.5) 0.003 −0.4 (1.0) <0.001 −0.2 (1.1) <0.001 −0.4 (1.0) <0.001
Hypoglycaemia (event per person-year/percent with event)
 Overall Baseline 2.67/8.3 1.47/6.6 2.06/6.4 8.14/18.6 3.94/10.1 4.86/11.4 8.83/15.4
Week 24 1.75/7.4 0.26/1.4 1.37/5.0 4.09/13.6 2.1/7.6 1.17/5.0 5.44/15.3
ap 0.018 <0.001 <0.001 <0.001 <0.001 <0.001 0.943
 Minor Baseline 2.49/8.0 1.31/6.3 1.92/6.2 6.96/18.0 3.36/9.5 4.33/10.9 8.57/15.3
Week 24 1.75/7.4 0.26/1.4 1.37/5.0 4.03/13.4 2.09/7.6 1.17/5.0 5.44/15.3
ap 0.012 <0.001 <0.001 <0.001 <0.001 <0.001 0.7159
 Nocturnal Baseline 0.64/2.7 0.46/2.9 0.64/2.6 3.23/11.4 1.07/4.6 1.58/5.4 2.33/7.8
Week 24 0.3/1.7 0.05/0.3 0.28/1.3 1.26/5.3 0.57/2.9 0.19/1.1 0.89/4.3
ap <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
 Major Baseline 0.18/0.9 0.16/1.0 0.14/0.6 1.18/5.3 0.58/2.5 0.53/1.7 0.26/1.0
Week 24 0.00/0.0 0.00/0.0 0.00/0.0 0.06/0.2 0.01/0.1 0.00/0.0 0.00/0.0
ap <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

References in context

  • There were differences in starter insulin doses between regions, with the Middle East/Gulf being highest at around 42U/day and South and East Asia being lowest (26 and 27U/day, respectively) (Table 4).
    Go to context

  • Although baseline measure of blood glucose control were very similar between regions, the largest reductions in HbA1c were seen in China (−28mmol/mol [−2.5%]), and smallest in north Africa (−18mmol/mol [−1.6%]), but most clustered closely around the reduction for the entire cohort (Table 4).
    Go to context

  • Furthermore, in Russia the proportions of people affected (15.4% at baseline and 15.3% at 24 weeks, NS) did not reflect the event rate (Table 4).
    Go to context

  • Furthermore, in Russia the proportions of people affected (15.4% at baseline and 15.3% at 24 weeks, NS) did not reflect the event rate (Table 4).
    Go to context

  • HDL cholesterol values remained largely unchanged during the study and were similar across all regions (Table 4).
    Go to context

  • HDL cholesterol values remained largely unchanged during the study and were similar across all regions (Table 4).
    Go to context

  • Regional baseline rates of hypoglycaemia varied considerably, but all reported reductions in overall hypoglycaemia (Table 4).
    Go to context

Data are mean (SD) except for hypoglycaemia.

a p-value is for difference in percent of people with at least one event.


Back to list