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The effectiveness and safety of beginning insulin aspart together with basal insulin in people with type 2 diabetes in non-Western nations: Results from the A1chieve observational study

Philip D. Home, Zafar A. Latif, Guillermo González-Gálvez, Vinay Prusty and Zanariah Hussein

Diabetes Research and Clinical Practice, 3, 101, pages 326 - 332

Received 3 January 2013, Revised 15 May 2013, Accepted 6 June 2013, Published online Oct-2013


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Table 1 Participant characteristics according to pre-study insulin therapy.

Insulin-naïve Insulin-experienced
Basal insulin Premix insulin NPH plus meal-time human insulin
n 1594 519 947 586
Male/female(%) 59.7/40.3 52.2/47.8 52.3/47.7 44.5/55.5
Age (years) 53.1 (12.7) 54.1 (12.2) 52.7 (14.5) 53.7 (12.7)
Body weight(kg) 74.1 (16.8) 78.9 (17.8) 78.6 (17.3) 81.3 (18.2)
BMI (kg/m2) 26.9 (5.4) 28.8 (6.7) 28.9 (6.1) 29.6 (6.0)
Duration of diabetes (years) 7.1 (6.1) 10.9 (6.3) 11.7 (7.1) 11.7 (6.9)
HbA1c (%/mmol/mol) 10.1 (2.1)/87 (23) 9.7 (1.7)/83 (19) 9.4 (1.7)/79 (19) 9.4 (1.6)/79 (17)

References in context

  • Participant characteristics are provided in Table 1.
    Go to context

  • It seems reasonable to speculate that the conformity of the 24-week results simply reflects the broadly similar insulin regimens then being used, participant characteristics not being very different apart from the 4-year shorter duration of diabetes in the prior insulin-naïve group (Table 1).
    Go to context

Values are mean (SD) unless otherwise noted.

BMI, body mass index.

Table 2 Baseline and 24-week safety and effectiveness data for participants starting insulin aspart with basal insulin by prior glucose-lowering regimen.

Outcome measure Prior glucose-lowering management
Insulin-naive Insulin-experienced
Basal insulin Premix insulin NPH plus meal-time human insulin
Insulin dose (U/kg/day) Pre-study - 0.40 (0.21) 0.68 (0.28) 0.76 (0.30)
Day 1 0.60 (0.25) 0.65 (0.25) 0.73 (0.28) 0.73 (0.29)
Week 24 0.64 (o.29) 0.71 (0.28) 0.81 (0.32) 0.85 (0.32)
HbAic (%) Baseline 10.1 (2.1) 9.7 (1.7) 9.4 (1.7) 9.4 (1.6)
Week 24 7.3 (1.2) 7.4 (1.2) 7.4 (1.1) 7.5 (1.3)
Change -2.8 (2.0) -2.2 (1.7) -2.0 (1.7) -1.8 (1.6)
p -value <0.001 <0.001 <0.001 <0.001
HbA1c (mmol/mol) Baseline 87 (23) 83 (19) 79 (19) 79 (17)
Week 24 56 (13) 57 (13) 57 (12) 58 (14)
Change -31 (22) -24 (19) -22 (19) -20 (17)
p -value <0.001 <0.001 <0.001 <0.001
FPG (mmol/L) Baseline 11.9 (4.1) 10.3 (3.3) 10.5 (3.8) 10.0 (3.2)
Week 24 7.0 (1.7) 6.8 (1.6) 6.9 (1.8) 7.1 (2.0)
Change -4.9 (4.2) -3.4 (3.4) -3.7 (3.7) -2.9 (3.2)
p-value <0.001 <0.001 <0.001 <0.001
PPPG (post-breakfast) (mmol/L) Baseline 15.7 (5.0) 14.4 (4.1) 14.6 (4.7) 12.6 (4.1)
Week 24 9.0 (2.3) 8.9 (2.4) 8.9 (2.2) 8.7 (2.3)
Change -6.7 (5.0) -5.5 (4.4) -5.7 (4.7) -3.9 (3.9)
p-value <0.001 <0.001 <0.001 <0.001
Body weight (kg) Baseline 74.7 (16.9) 79.6 (17.3) 79.2 (16.0) 81.7 (17.7)
Week 24 74.6 (15.5) 79.0 (16.1) 79.0 (15.1) 81.3 (16.5)
Change -0.0 (4.2) -0.6 (3.9) -0.3 (3.5) -0.4 (3.6)
p-value NS 0.004 0.043 0.028
Total serum cholesterol (mmol/L) Baseline 5.6 (1.5) 5.4 (1.4) 5.2 (1.3) 5.6 (1.4)
Week 24 4.9 (1.0) 4.8 (1.0) 4.7 (0.9) 5.1 (1.1)
Change -0.7 (1.3) -0.5 (1.1) -0.5 (1.1) -0.4 (1.2)
p-value <0.001 <0.001 <0.001 <0.001
Serum triglycerides (mmol/L) Baseline 2.2 (1.2) 2.1 (1.1) 2.1 (1.1) 1.9 (1.0)
Week 24 1.7 (0.7) 1.7 (0.7) 1.8 (0.7) 1.7 (0.8)
Change -0.5 (1.0) -0.4 (0.9) -0.3 (0.8) -0.2 (0.8)
p-value <0.001 <0.001 <0.001 <0.001
Serum HDL-C (mmol/L) Baseline 1.2 (0.5) 1.1 (0.5) 1.1 (0.4) 1.2 (0.6)
Week 24 1.3 (0.4) 1.2 (0.4) 1.2 (0.3) 1.3 (0.5)
Change 0.1 (0.4) 0.1 (0.4) 0.1 (0.4) 0.1 (0.5)
p-value <0.001 0.076 <0.001 0.001
Serum LDL-C (mmol/L) Baseline 3.3 (1.1) 3.1 (1.0) 3.1 (1.0) 3.0 (1.1)
Week 24 2.8 (0.8) 2.7 (0.9) 2.7 (0.8) 2.8 (1.0)
Change -0.5 (1.0) -0.4 (0.8) -0.4 (0.9) -0.2 (1.2)
p-value <0.001 <0.001 <0.001 0.01
SBP (mmHg) Baseline 133.7 (18.1) 134.9 (16.9) 134.0 (18.1) 135.5 (18.5)
Week 24 127.6 (12.6) 130.2 (14.0) 128.4 (12.0) 130.0 (13.2)
Change -6.1 (15.7) -4.7 (15.6) -5.6 (14.9) -5.5 (15.8)
p-value <0.001 <0.001 <0.001 <0.001
QoL UK score Baseline 0.74 (0.25) 0.70 (0.23) 0.70 (0.26) 0.68 (0.21)
Week 24 0.84 (0.20) 0.81 (0.19) 0.82 (0.20) 0.82 (0.19)
Change 0.10 (0.25) 0.11 (0.24) 0.13 (0.26) 0.13 (0.22)
p-value <0.001 <0.001 <0.001 <0.001
QoL VAS score Baseline 65.6 (17.4) 63.2 (17.9) 64.3 (17.3) 59.8 (18.1)
Week 24 77.8 (12.0) 77.3 (11.7) 76.7 (12.9) 74.6 (14.3)
Change 12.2 (17.9) 14.1 (18.1) 12.4 (18.8) 14.9 (18.0)
p-value value <0.001 <0.001 <0.001 <0.001
Overall Baseline 1.7/5.4 10.3/22.9 11.5/26.8 22.5/37.2
Week 24 3.0/8.7 3.3/10.3 3.4/11.1 4.4/13.5
Minor Baseline 1.5/5.4 9.2/22.2 10.2/25.2 20.7/36.2
Week 24 3.0/8.7 3.3/10.3 3.3/11.1 4.4/13.5
Nocturnal Baseline 0.4/1.8 4.5/12.9 3.5/13.4 6.5/19.6
Week 24 0.4/2.4 0.7/4.3 0.8/4.8 0.8/4.4
Major Baseline 0.2/0.6 1.1/4.8 1.3/6.5 1.8/7.0
Week 24 0.0/0.0 0.0/0.0 0.0/0.0 0.0/0.0

References in context

  • Insulin-naïve participants started on a basal plus insulin aspart regimen had a total insulin dose at day 1 of 0.60 U/kg/day, and at study end of 0.64 U/kg/day (Table 2).
    Go to context

  • Whether measured as HbA1c, FPG or PPPG the level of blood glucose control reached at 24 weeks was strikingly similar across all four insulin regimen groups in contrast to baseline levels, which were highest in the insulin-naïve population (mean HbA1c [SD] 10.1 [2.1] % [87 (23) mmol/mol]) and lowest in those on the human insulin multiple injection regimen (9.4 [1.6] % [79 (17) mmol/mol]) (Table 2).
    Go to context

  • Severe hypoglycaemia was very infrequent, barely registering in the 4-week ascertainment periods at either baseline (range from 0.2 to 1.8 events per person-year) or 24 weeks (0.0 events per person- year for all groups), but without any suggestion of an increase (Table 2).
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  • Severe hypoglycaemia was very infrequent, barely registering in the 4-week ascertainment periods at either baseline (range from 0.2 to 1.8 events per person-year) or 24 weeks (0.0 events per person- year for all groups), but without any suggestion of an increase (Table 2).
    Go to context

  • Severe hypoglycaemia was very infrequent, barely registering in the 4-week ascertainment periods at either baseline (range from 0.2 to 1.8 events per person-year) or 24 weeks (0.0 events per person- year for all groups), but without any suggestion of an increase (Table 2).
    Go to context

  • Systolic BP also fell by clinically-useful amounts, although it had not been particularly elevated overall at baseline, with the biggest change observed in the insulinnaïve group (mean [SD] change from baseline −6.1 [15.7] mmHg; p<0.001) (Table 2).
    Go to context

  • Systolic BP also fell by clinically-useful amounts, although it had not been particularly elevated overall at baseline, with the biggest change observed in the insulinnaïve group (mean [SD] change from baseline −6.1 [15.7] mmHg; p<0.001) (Table 2).
    Go to context

  • Systolic BP also fell by clinically-useful amounts, although it had not been particularly elevated overall at baseline, with the biggest change observed in the insulinnaïve group (mean [SD] change from baseline −6.1 [15.7] mmHg; p<0.001) (Table 2).
    Go to context

  • Systolic BP also fell by clinically-useful amounts, although it had not been particularly elevated overall at baseline, with the biggest change observed in the insulinnaïve group (mean [SD] change from baseline −6.1 [15.7] mmHg; p<0.001) (Table 2).
    Go to context

  • Baseline HRQoL scores were similarly impaired using both scales (EQ-5D UK and EQ-5D VAS) across all therapy groups (mean [SD] baseline VAS score ranged from 59.8 [18.1] to 65.6 [17.4]) (Table 2).
    Go to context

Values are mean (SD) unless otherwise noted.

FPG, fasting plasma glucose; PPPG, postprandial plasma glucose; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; SBP, systolic blood pressure; QoL, quality of life.

Table 3 Insulin injection frequency in people starting insulin aspart with basal insulin by prior glucose-lowering therapy.

Prior therapy Participants (%)
Meal-time insulin injection number Basal insulin injection number
One Two Three Three+ One Two Three
Insulin-naïve Day 1 8.3 11.0 80.3 0.4 90.0 9.9 0.2
Week 24 6.9 13.2 78.6 1.3 87.3 12.6 0.1
Basal insulin Pre-study - - - 67.8 29.5 2.5
Day 1 14.7 18.3 66.6 0.4 84.4 15.3 0.2
Week 24 10.7 19.7 68.7 1.0 80.4 19.6 0.0
Premix insulin Pre-study (total) 2.5 92.4 5.0 0.1
Day 1 7.2 12.3 80.5 0.0 93.1 6.8 0.1
Week 24 6.2 14.2 78.8 0.7 92.3 7.7 0.0
NPH plus meal-time Pre-study 6.5 31.2 61.6 0.7 30.5 68.6 0.9
human insulin Day 1 5.6 14.5 79.1 0.7 62.7 37.1 0.2
Week 24 4.0 12.4 81.8 1.8 56.1 43.7 0.2

References in context

  • Insulin injection frequencies at pre-study, baseline and study end are included in Table 3.
    Go to context


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