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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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4. Results

Participant characteristics are provided in Table 1. The insulin-naïve group had a shorter duration of diabetes and somewhat worse blood glucose control than the insulin- experienced populations. Prior to the study, 79% of participants in the insulin-naïve group, 80% of those previously using basal insulin, 65% of those previously using premix and 51% of those previously using NPH + meal-time human insulin were taking OGLDs. At baseline, use of OGLDs was 45% in those who were insulin naïve, 55% in those previously using basal insulin, 51% in the premix group, and 50% in the NPH + meal-time human insulin group.

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.

4.1. Safety

No individual previously insulin naïve experienced a SADR during the study; four SADRs were experienced in two people previously treated with human meal-time + basal insulin (diabetic ketoacidosis and hypoglycaemia; and a fall plus pelvic fracture); three SADRs were reported in three people previously using only basal insulin (inadequate control of diabetes mellitus, hypoglycaemia, and hypoglycaemic unconsciousness); and two people previously treated with premix insulin reported hypoglycaemia as an SADR.

One person previously using basal insulin developed pancreatic carcinoma during the trial, and one previously using NPH plus meal-time human insulin experienced angina pectoris. Otherwise no cardiac events or cancers were reported as adverse events throughout the study period.

4.2. Insulin dose

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). Those starting from a basal plus meal-time human insulin regimen started at 0.76 U/kg/day, then decreased slightly at day 1 (0.73 U/kg/day) before increasing to 0.85 U/kg/day at 24 weeks. Insulin injection frequencies at pre-study, baseline and study end are included in Table 3.

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).
    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

  • 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

Approximately 80% of patients injected meal-time aspart three times daily for the prior insulin-naïve, premix and NPH plus meal-time human insulin sub-groups, and approximately 70% of those who added insulin aspart to a basal insulin. The majority of participants (84–93%) injected basal insulin once daily in all groups, apart from those using NPH plus meal-time human insulin prior to the study (63%).

4.3. Blood glucose control

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). As a result, in regressing to the same level, improvements were greatest in the insulin-naïve group (mean HbA1c [SD] change from baseline −2.8 [2.0] % (31 [22] x A. Gallagher, P.D. Home. The effect of improved post-prandial blood glucose control on post-prandial metabolism and markers of vascular risk in people with Type 2 diabetes. Diabetes Res Clin Pract. 2005;67:196-203 Crossref. mmol/mol); p < 0.001) and smallest in the human multiple injection group (−1.8 [1.6] % (20 [17] x J. Gordon, R.D. Pockett, A.P. Tetlow, P. McEwan, P.D. Home. A comparison of intermediate and long-acting insulins in people with type 2 diabetes starting insulin: an observational database study. Int J Clin Pract. 2010;64:1609-1618 Crossref. mmol/mol); p < 0.001). It was not otherwise apparent that the groups starting with no prior meal-time insulin (i.e. insulin-naïve and basal alone) saw greater relative postprandial falls (mean PPPG [SD] change from baseline −6.7 [5.0] mmol/L and −5.5 [4.4] mmol/L, respectively; p < 0.001 for both) than the groups taking some meal-time insulin beforehand (−5.7 [4.7] mmol/L for previous premix users and −3.9 [3.9] mmol/L for previous NPH plus meal-time human insulin users; p < 0.001 for both).

4.4. Hypoglycaemia

In the four weeks before baseline, hypoglycaemia rates of any kind were lowest in the insulin-naïve group (overall, 1.7 events per person-year) and highest in the multiple insulin injection group (overall, 22.5 events per person-year) (Table 2). These differences were much smaller in the four weeks preceding 24 weeks, although the same pattern is discernible: while hypoglycaemia rates rose in those starting insulin for the first time (to 3.0 events per person-year), they fell in the other groups (overall 3.3–4.4 events per person- year. Overall rates in the final period correspond to around one event per 3–4 months on average, but 9–14% of participants on any regimen had at least one event in the final 4-week period (Table 2), suggesting that a small minority of people accounted for most events. 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).

4.5. Body weight, blood lipids and blood pressure control

Those insulin-naïve participants starting a basal plus aspart regimen did not gain or lose weight over the 24 weeks of improved blood glucose control (mean [SD] change in body weight from baseline −0.0 [4.2] kg; NS) (Table 2). Those changing from another insulin regimen on average lost a clinically insignificant amount of weight (−0.6 [3.9] kg; p = 0.004 for previous basal insulin users, −0.3 [3.5] kg; p = 0.043 for previous premix users, −0.4 [3.6] kg; p = 0.028 for previous NPH plus meal-time human insulin users (Table 2). Serum lipid profile improved for all measures and for all insulin groups, with clinically-useful improvements of around 10% or more in total and LDL cholesterol, smallest in the group changing from the human insulin multiple injection regimen (mean [SD] change from baseline −0.4 [1.2] mmol/L; p < 0.001, and −0.2 [1.2] mmol/L; p = 0.01, respectively) (Table 2). 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). Data are not available on the use of lipid-lowering or anti-hypertensive therapy at the two time points.

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). By 24 weeks they had improved clinically and statistically significantly in all four groups (mean [SD] change from baseline ranged from 12.2 [17.9] to 14.9 [18.0]), and to similar levels (mean [SD] VAS scores at study end ranged from 74.6 [14.3] to 77.8 [12.0]). Attained scores on both measures corresponded to approximately an 80% best possible HRQoL.

 
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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).
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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).
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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).
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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).
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  • 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).
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  • 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).
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  • 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).
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  • 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).
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  • 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).
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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.
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References

Label Authors Title Source Year
[17]

References in context

  • As a result, in regressing to the same level, improvements were greatest in the insulin-naïve group (mean HbA1c [SD] change from baseline −2.8 [2.0] % (31 [22] mmol/mol); p<0.001) and smallest in the human multiple injection group (−1.8 [1.6] % (20 [17] mmol/mol); p<0.001).
    Go to context

J. Gordon, R.D. Pockett, A.P. Tetlow, P. McEwan, P.D. Home A comparison of intermediate and long-acting insulins in people with type 2 diabetes starting insulin: an observational database study Crossref. Int J Clin Pract. 2010;64:1609-1618 2010
[22]

References in context

  • As a result, in regressing to the same level, improvements were greatest in the insulin-naïve group (mean HbA1c [SD] change from baseline −2.8 [2.0] % (31 [22] mmol/mol); p<0.001) and smallest in the human multiple injection group (−1.8 [1.6] % (20 [17] mmol/mol); p<0.001).
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  • Improved PPPG control with insulin aspart vs. human insulin both with NPH insulin was also seen in a 12-week crossover study of 21 people with type 2 diabetes [22], although there was no difference in HbA1c between the two insulins.
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A. Gallagher, P.D. Home The effect of improved post-prandial blood glucose control on post-prandial metabolism and markers of vascular risk in people with Type 2 diabetes Crossref. Diabetes Res Clin Pract. 2005;67:196-203 2005

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