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Insulin detemir in the management of type 2 diabetes in non-Western countries: Safety and effectiveness data from the A1chieve observational study

Alexey Zilov, Nabil El Naggar, Siddharth Shah, Chunduo Shen and Jihad Haddad

Diabetes Research and Clinical Practice, 3, 101, pages 317 - 325

Received 24 December 2012, Revised 16 May 2013, Accepted 6 June 2013, Published online Oct-2013


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Fig. 1 Changes in the incidence of hypoglycaemia in insulin-naïve and prior insulin users after 24 weeks of treatment with insulin detemir ± oral glucose-lowering drugs.

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References in context

  • For people changing insulin to treatment with insulin detemir, significant reductions were also reported in the incidence of overall, minor, and nocturnal events (p<0.0001 for all) (Fig. 1).
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Table 1 Patient numbers and characteristics by pre-study therapy and regional distribution in the insulin detemir subgroup and entire A1chieve study population.

Demographic Insulin detemir subgroup population A1chieve study population
Global cohort Insulin-naïve Insulin- experienced Global cohort Insulin-naïve Insulin- experienced
n (%) 15,545 (100) 12,078 (77.7) 3467 (22.3) 66,726 (100) 44,872 (67.2) 21,854 (32.8)
Gender, M/F (%) 54.1/45.9 55.0/45.0 51.3/48.7 55.6/44.4 57.3/42.7 51.9/48.1
Age (years) 54.6 (11.5) 54.0 (11.3) 56.8 (11.9) 54.0 (12.0) 53.2 (11.6) 55.6 (12.5)
Body weight (kg) 76.6 (16.3) 76.5 (16.3) 76.7 (16.3) 72.9 (15.0) 71.7 (14.4) 75.3 (15.9)
BMI (kg/m2) 28.2 (5.3) 28.2 (5.3) 28.4 (5.5) 27.1 (5.0) 26.7 (4.7) 27.9 (5.50
Duration of diabetes (years) 8.4 (6.0) 7.6 (5.5) 11.0 (7.0) 8.0 (19) 80 (19) 79 (20)
>2 OGLDs, n (%) 1608 (11.7) 1320 (12.1) 288 (10.2) 10,981 (20.1) 8971 (23.1) 2010 (12.7)
HbA1c (% [mmol/mol]) 9.5 (1.6) [80] 9.5 (1.6) [80] 9.3 (1.7) [78] 9.5 (1.7) [80] 9.5 (1.7) [80] 9.4 (1.8) [79]
Geographic region (% of cohort)
China 137 (100) 88 (64.2) 49 (35.8) 11,020 (100) 8206 (74.4) 2814 (25.6)
South Asia 3079 (100) 2608 (84.7) 471 (15.3) 22,447 (100) 18,067 (80.5) 4380 (19.5)
East Asia 4230 (100) 3195 (75.5) 1035 (24.5) 10,032 (100) 6594 (65.7) 3438 (34.3)
North Africa 1746 (100) 1250 (71.6) 496 (28.4) 4039 (100) 1969 (48.7) 2070 (51.3)
Middle East and Gulf 4474 (100) 3560 (79.6) 914 (20.4) 14,976 (100) 7501 (50.1) 7475 (49.9)
Latin America 643 (100) 405 (63.0) 238 (37.0) 1138 (100) 636 (55.9) 502 (44.1)
Russia 1236 (100) 972 (78.6) 264 (21.4) 3074 (100) 1899 (61.8) 1175 (38.2)

References in context

  • The majority of patients starting basal insulin or switching to insulin detemir came from the Middle East/Gulf and East Asian regions (28.8 and 27.2%, respectively) (Table 1).
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  • The majority of patients starting basal insulin or switching to insulin detemir came from the Middle East/Gulf and East Asian regions (28.8 and 27.2%, respectively) (Table 1).
    Go to context

Data are mean (SD), unless otherwise stated.

BMI, body mass index; OGLD, oral glucose-lowering drug.

Table 2 Outcome measures by pre-study therapy in the insulin detemir subgroup and entire A1chieve study population.

Outcome measure Insulin detemir subgroup population A1chieve study population
Global cohort Insulin- naïve Insulin- experienced Global cohort Insulin- naïve Insulin- experienced
Insulin dose (U/kg/day) n 15,545 12,078 3467 66726 44872 21854
Pre-study 0.42 (0.24) 0.42 (0.24) 0.55 (0.29) 0.55 (0.29)
Baseline 0.27 (0.15) 0.24 (0.13) 0.35 (0.19) 0.44 (0.24) 0.38 (0.20) 0.55 (0.27)
Week 24 0.37 (0.20) 0.35 (0.18) 0.45 (0.24) 0.50 (0.26) 0.44 (0.22) 0.62 (0.30)
HbA1c (% [mmol/mol]) n 10,581 8459 2122 44,661 30, 369 14,292
Baseline 9.5 (1.6) [80] 9.5 (1.6) [80] 9.3 (1.7) [78] 9.5 (1.7) [80] 9.5 (1.7) [80] 9.4 (1.8) [79]
Week 24 7.5 (1.2) [58] 7.4 (1.1) [57] 7.6 (1.3) [60] 7.4 (1.1) [57] 7.4 (1.0) [57] 7.6 (1.2) [60]
Change −2.0 (1.6) [22] x EuroQol Group. EuroQol – a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199-208 −2.1 (1.6) [23] x L. Meneghini, C. Koenen, W. Weng, J.L. Selam. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes – results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007;9:902-913 Crossref. −1.6 (1.7) [17] x C. Fajardo Montañana, C. Hernández Herrero, M. Rivas Fernández. Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight Type 2 diabetes patients: the PREDICTIVE BMI clinical trial. Diabet Med. 2008;25:916-923 −2.1 (1.7) [23] x L. Meneghini, C. Koenen, W. Weng, J.L. Selam. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes – results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007;9:902-913 Crossref. −2.2 (1.7) [23] x L. Meneghini, C. Koenen, W. Weng, J.L. Selam. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes – results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007;9:902-913 Crossref. −1.8 (1.7) [19] x L.F. Meneghini, K.H. Rosenberg, C. Koenen, M.J. Merilainen, H.J. Lüddeke. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab. 2007;9:418-427 Crossref.
p-value <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
People reaching HbA1c <7.0% n 13,190 (100.0) 10,376 (100.0) 2814 (100.0) 57,250 (100.0) 38,639 (100.0) 18,611 (100.0)
[53 mmol/mol] (%) Baseline 3.0 2.1 6.2 3.9 3.0 5.6
Week 24 31.5 31.7 30.3 31.8 32.0 31.3
FPG, pre-breakfast (mmol/L) n 10742 8560 2182 48,191 33,087 15,104
Baseline 10.9 (3.3) 11.2 (3.2) 9.9 (3.3) 10.9 (3.5) 11.2 (3.4) 10.5 (3.7)
Week 24 7.1 (2.0) 7.0 (1.9) 7.3 (2.3) 7.1 (1.9) 7.1 (1.8) 7.2 (2.2)
Change −3.9 (3.3) −4.2 (3.2) −2.6 (3.5) −3.8 (3.5) −4.1 (3.3) −3.2 (3.8)
p-value <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
PPG (mmol/L), post-breakfast n 7148 5757 1391 33,742 23,334 10,408
Baseline 14.8 (4.2) 15.0 (4.2) 13.8 (4.3) 15.1 (4.4) 15.5 (4.3) 14.2 (4.5)
Week 24 9.6 (2.9) 9.5 (2.8) 9.9 (3.2) 9.7 (2.9) 9.8 (2.9) 9.7 (3.0)
Change −5.1 (4.3) −5.5 (4.2) −3.8 (4.3) −5.4 (4.5) −5.8 (4.4) −4.5 (4.6)
p-value <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
Body weight (kg) n 11,934 9336 2598 50,059 33,716 16,343
Baseline 76.6 (16.3) 76.5 (16.3) 76.7 (16.3) 73.3 (14.8) 72.1 (14.3) 75.7 (15.7)
Week 24 76.2 (15.5) 76.2 (15.4) 76.0 (15.7) 73.3 (14.1) 72.2 (13.5) 75.7 (15.1)
Change −0.4 (4.0) −0.3 (4.0) −0.7 (3.6) 0.1 (3.7) 0.1 (3.7) −0.0 (3.6)
p-value <0.001 <0.001 <0.001 <0.001 <0.001 0.081
SBP (mmHg) n 11,620 9077 2543 45,285 29,595 15,690
Baseline 133.2 (16.7) 133.3 (16.7) 133.0 (16.9) 134.2 (17.8) 134.0 (17.7) 134.7 (18.0)
Week 24 128.0 (14.9) 127.9 (15.2) 128.4 (13.7) 127.9 (13.5) 127.3 (13.3) 129.0 (13.7)
Change −5.2 (17.3) −5.4 (17.7) −4.5 (15.6) −6.3 (17.1) −6.6 (17.4) −5.7 (16.6)
p-value <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
Total cholesterol (mmol/L) n 5791 4529 1262 20, 293 11,994 8299
Baseline 5.3 (1.3) 5.3 (1.2) 5.2 (1.4) 5.3 (1.3) 5.4 (1.3) 5.2 (1.3)
Week 24 4.8 (1.0) 4.8 (0.9) 4.8 (1.0) 4.8 (1.0) 4.8 (1.0) 4.8 (1.0)
Change −0.5 (1.1) −0.6 (1.1) −0.4 (1.1) −0.5 (1.2) −0.6 (1.2) −0.4 (1.2)
p-value <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
HDL cholesterol (mmol/L) n 4388 3418 970 17,306 10,189 7117
Baseline 1.1 (0.4) 1.1 (0.4) 1.1 (0.4) 1.1 (0.4) 1.2 (0.4) 1.1 (0.4)
Week 24 1.2 (0.4) 1.2 (0.3) 1.2 (0.4) 1.2 (0.4) 2.7 (0.4) 1.2 (0.4)
Change 0.0 (0.4) 0.0 (0.3) 0.0 (0.4) 0.1 (0.4) 0.1 (0.4) 0.0 (0.4)
p-value <0.001 <0.001 0.012 <0.001 <0.001 <0.001
LDL cholesterol (mmol/L) n 4428 3459 969 17,494 10,304 7190
Baseline 3.1 (1.0) 3.1 (1.0) 3.0 (1.0) 3.1 (1.0) 3.2 (1.0) 3.1 (1.1)
Week 24 2.7 (0.8) 2.7 (0.8) 2.7 (0.9) 2.8 (0.9) 2.7 (0.9) 2.8 (0.9)
Change −0.4 (1.0) −0.4 (1.0) −0.3 (0.9) −0.4 (1.0) −0.4 (1.0) −0.3 (0.9)
p-value <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
Triglycerides (mmol/L) n 5413 4251 1162 19,856 11,672 8184
Baseline 2.1 (1.0) 2.1 (1.0) 1.9 (1.0) 2.1 (1.1) 2.1 (1.1) 2.0 (1.1)
Week 24 1.7 (0.7) 1.7 (0.7) 1.7 (0.8) 1.8 (0.7) 1.7 (0.7) 1.8 (0.7)
Change −0.3 (0.9) −0.4 (0.9) −0.2 (0.9) −0.3 (0.9) −0.4 (1.0) −0.3 (0.9)
p-value <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

References in context

  • Overall, the proportion of patients reaching HbA1c<7.0% [53 mmol/mol] increased from 3.0% at baseline to 31.5% after 24 weeks; similar results were reported for the pre-study therapy subgroups (Table 2).
    Go to context

  • Overall, the proportion of patients reaching HbA1c<7.0% [53 mmol/mol] increased from 3.0% at baseline to 31.5% after 24 weeks; similar results were reported for the pre-study therapy subgroups (Table 2).
    Go to context

  • In prior insulin users, the pre-study mean insulin dose was 0.42±0.24 IU/kg/day, and 0.45±0.24 U/kg/day of insulin detemir at 24 weeks (Table 2).
    Go to context

  • Mean blood lipid profiles improved overall by −0.5±1.1 mmol/L; there was no clinically meaningful change in high-density lipoprotein (HDL) cholesterol, but low-density lipoprotein cholesterol (LDL) values fell by −0.4±1.0 mmol/L and triglycerides by −0.3±0.9 mmol/L (p<0.001) (Table 2).
    Go to context

  • Mean blood lipid profiles improved overall by −0.5±1.1 mmol/L; there was no clinically meaningful change in high-density lipoprotein (HDL) cholesterol, but low-density lipoprotein cholesterol (LDL) values fell by −0.4±1.0 mmol/L and triglycerides by −0.3±0.9 mmol/L (p<0.001) (Table 2).
    Go to context

  • Mean blood lipid profiles improved overall by −0.5±1.1 mmol/L; there was no clinically meaningful change in high-density lipoprotein (HDL) cholesterol, but low-density lipoprotein cholesterol (LDL) values fell by −0.4±1.0 mmol/L and triglycerides by −0.3±0.9 mmol/L (p<0.001) (Table 2).
    Go to context

Data are mean (SD) unless otherwise stated.

FPG, fasting plasma glucose; HDL, high-density lipoprotein; LDL, low-density lipoprotein; PPG, postprandial plasma glucose; SBP, systolic blood pressure.


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