Table 2.
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.
Values obtained by digitising published figures.
Values obtained by calculations based on published data.
Parallel study design.
Crossover study design.
Incidence reported as events per patient year.
Prevalence reported as % with at least one event.
Prevalence reported as number of events/number of patients.