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. 2011 Sep 8;166(2):159–170. doi: 10.1530/EJE-11-0022

Table 2.

All randomised controlled trials comprising a basal insulin analogue regimen in previously insulin-naïve patients with type 2 diabetes. Basal analogue arm baseline demographic and treatment effects, listed in rank order according to duration of diabetes. Age (mean±s.d.) or (median (quartiles)); duration of diabetes (mean±s.d.) or (median (quartiles)).

Trial Insulin treatment OAD treatment Study HbA1c (%) Hypoglycaemia Weight
Ref. Prep. Regimen OAD Change from baseline Duration (weeks) Patients (n) Male (%) Diabetes duration (years) Baseline EOT Episodes Definition Change (kg)
(28) Iglar QD 24c 53 43 5.5±2.8 8.1±1.3 7.3 (7.8, 6.7)a 3.7b,e S/BG <54 mg/dl +0.7±3.8
(42) Iglar QD 48c 121 48 6.5±4.9 9.4±1.2 6.9 5.0e BG <70 mg/dl +3.9
(34) Iglar QD +Met/SU 16c 138 47 7.4±8.2b 9.0±1.2b 7.6 2.6e S/BG <60 mg/dl +3.3±4.7b
(36) Idet QD FBG <5.0 20c 122 56 7.9 8.0 6.8 7.5e S/BG <56 mg/dl +0.9±0.4
(38) Iglar QD −SU+Met 36c 55 53 8.2±5.3 8.7±0.7 7.1±0.8a,b 6.0e S/BG <72 mg/dl +2.8±3.5
(39) Iglar QD pm +SU 28c 227 58 8.2 9.1±1.0 8.1±1.3 43.0f S/BG <75 mg/dl +3.7±3.6
(86) Iglar QD Usual/lab 24c 1491 52 8.4±6.4 8.9±1.5 7.5 3.7e BG <70 mg/dl Not given
(86) Iglar QD Usual/POC 24c 1363 53 8.4±6.4 8.9±1.6 7.3 3.7e BG <70 mg/dl Not given
(87) Iglar QD ±Met±SU±TZD 26 116 66 8.4±6.4 8.5±0.7 7.3±1.1b 36.8f BG <60 mg/dl +3.0±3.2b
(26) Iglar QD 16d 60 57 8.4±4.9 9.2±1.3 7.3±0.1 2.4b,e BG <54 mg/dl +1.5±0.5
(44) Iglar QD 24c 367 55 8.4±5.6 8.6±0.9 7.0 9.2e BG <56 mg/dl Not given
(86) Iglar QD Active/lab 24c 1501 49 8.6±6.4 8.9±1.6 7.5 6.0e BG <70 mg/dl Not given
(86) Iglar QD Active/POC 24c 1366 50 8.7±6.4 8.8±1.5 7.3 6.0e BG <70 mg/dl Not given
(30) Iglar QD +Met±TZD 28c 116 56 8.9±4.8 9.8±1.4 7.4±1.2 0.7e S/BG <56 mg/dl +3.5±4.5
(21) Idet QD 52c 234 61 9.0 (6.0, 12.0) 8.4±0.8 7.6±1.0 2.3e BG <56 mg/dl +1.9±4.2
(36) Idet QD FBG <6.1 20c 122 64 9.0 7.9 7.0 5.3e S/BG <56 mg/dl +0.1±0.4
(88) Iglar QD 44 204 52 9.0±6.8 8.7±1.0 7.0±0.7 4.2e BG <60 mg/dl +3.0±4.3
(29) Iglar QD +Met 16d 105 63b 9.0±6.6b 8.7±1.3 7.8±1.1 4.8b,e S/BG <63 mg/dl +1.6±1.0
(39) Iglar QD am +SU 28c 236 52 9.0 9.1±1.0 7.8±1.2 56.0f S/BG <75 mg/dl +3.9±4.5
(47) Iglar QD +Met 36 61 62 9.0±7.8b 9.5±0.8b 7.1±0.8b 5.4e BG <72 mg/dl +3.5±5.5b
(45) Idet QD/BID 52c 291 57 9.1±6.1 8.6±0.8 7.2±1.7b 2.9e BG <56 mg/dl +3.0±6.8b
(45) Iglar QD 52c 291 59 9.1±6.4 8.6±0.8 7.1±1.7b 2.9e BG <56 mg/dl +3.9±6.8b
(89) Iglar QD 26 260 57 9.2±5.7 8.3±1.0 7.1±1.6a,b 6.3e S/BG <60 mg/dl +1.8±3.0a,b
(24) Iglar QD 24c 1046 53 9.3±5.9 9.0±1.2 7.3±1.1 23.1e S/BG <70 mg/dl +2.5±4.0
(46) Iglar QD am +SU 24c 312 55 9.5±6.1 8.8±1.0 7.2±1.1 43.1f S/BG <50 mg/dl +2.1
(23) Iglar QD +Met+SU ? 26c 238 41 9.5±6.1 8.5±1.1 7.3 4.8e S/BG <56 mg/dl +1.7
(41) Idet BID 24c 227 49 9.6±6.6 8.6±0.8 6.8 3.7e BG <54 mg/dl +1.2
(27) Iglar QD +SU±Met 24 177 61 9.9±7.3 8.8±1.0 7.2±0.9 4.1e BG <60 mg/dl +1.4±3.4
(35) Iglar QD 49c 103 55 10.0±6.2 7.6±0.3 6.8±0.7 55.3f Symptoms +0.9±2.9
(25) Iglar QD +SU 28c 127 49 10.2±6.2 8.9±1.3 7.9±1.3 9.0f BG <56 mg/dl +1.5
(37) Iglar QD +SU 24c 231 43 10.3±6.4 9.1±1.0 7.7±1.3 5.0e Symptoms Not given
(46) Iglar QD +SU 24c 312 55 10.3±6.8 8.8±1.0 7.2±1.1 38.4f S/BG <50 mg/dl +1.8
(43) Idet QD am 20c 165 59 10.5±7.6 9.1±1.0 7.5±1.0 91/32g BG <56 mg/dl +1.2
(43) Idet QD pm 20c 169 54 10.5±7.0 8.9±1.0 7.4±0.8 82/27g BG < 56 mg/dl +0.7

Ref., references; Prep., Preparation; Iglar, insulin glargine; Idet, insulin detemir; QD, once daily; BID, twice daily; Met, metformin; SU, sulphonylurea; TZD, thiazoledinedione; →, unchanged; ↓, reduced; ?, unknown; BG, blood glucose; S/BG, Symptoms or BG.

a

Values obtained by digitising published figures.

b

Values obtained by calculations based on published data.

c

Parallel study design.

d

Crossover study design.

e

Incidence reported as events per patient year.

f

Prevalence reported as % with at least one event.

g

Prevalence reported as number of events/number of patients.