Table 1.
Baseline characteristics of participants by allocation group
| Biphasic (n=137) | Aspart+detemir (n=138) | Detemir (n=137) | |
|---|---|---|---|
| Age (years) | 61.1 (5.6) | 60.2 (9.3) | 60.5 (8.9) |
| N (%) male | 90 (65.7) | 96 (69.6) | 95 (69.3) |
| Weight (kg) | 95.6 (14.8) | 97.5 (15.0) | 98.5 (15.1) |
| Body mass index* | 31.8 (4.4) | 32.2 (3.9) | 32.4 (4.3) |
| Waist–hip ratio | 1.00 (0.08) | 1.00 (0.08) | 1.01 (0.09) |
| N (%) smokers | 27 (19.7) | 19 (13.8) | 17 (12.6) |
| Median (IQR) alcohol consumption (units/week) | 2 (0–5) | 2 (0–5) | 2 (0–6) |
| N (%) Caucasians | 133 (97.1) | 133 (96.4) | 136 (99.3) |
| Diabetes and complications | |||
| Duration of type 2 diabetes (years) | 12.9 (6.5) | 12.9 (6.5) | 12.9 (6.2) |
| N (%) GAD65 antibodies ≥25 U/mL | 10 (7.3) | 9 (6.5) | 11 (8.0) |
| HbA1c (%) | 8.6 (1.0) | 8.5 (1.0) | 8.5 (1.1) |
| HbA1c (mmol/mol) | 70 (11) | 69 (11) | 69 (12) |
| Fasting p-glucose (mmol/L) | 10.7 (3.5) | 9.9 (3.1) | 10.4 (3.1) |
| Median (IQR) fasting p-insulin (pmol/L) | 68 (38–103) | 75 (45–132) | 65 (37–114) |
| Median (IQR) fasting C peptide (pmol/L) | 782 (418–1150) | 828 (507–1217) | 877 (466–1280) |
| N (%) prior CVD† | 35 (25.6) | 29 (21.0) | 36 (26.3) |
| N (%) microalbuminuria | 35 (26.5) | 23 (17.0) | 30 (22.2) |
| N (%) macroalbuminuria | 5 (3.8) | 8 (5.9) | 7 (5.2) |
| eCCr‡ (mL/min) | 129 (45) | 130 (45) | 124 (43) |
| N (%) simple retinopathy | 38 (28.4) | 42 (31.3) | 42 (31.3) |
| N (%) proliferative retinopathy | 10 (7.5) | 6 (4.5) | 9 (6.7) |
| N (%) prior laser treatment | 16 (11.9) | 7 (5.1) | 14 (10.5) |
| N (%) autonomous neuropathy | 23 (16.9) | 22 (16.1) | 24 (17.7) |
| N (%) peripheral neuropathy | 48 (35.0) | 46 (33.6) | 60 (44.1) |
| Blood pressure and lipids | |||
| Systolic blood pressure (mm Hg) | 138.5 (15.1) | 139.8 (14.8) | 139.8 (16.1) |
| Diastolic blood pressure (mm Hg) | 82.2 (9.2) | 82.4 (9.3) | 81.8 (9.4) |
| Heart rate (bpm) | 77 (13) | 76 (11) | 77 (11) |
| Total cholesterol (mmol/L) | 4.1 (0.9) | 4.2 (1.0) | 4.1 (1.0) |
| LDL cholesterol (mmol/L) | 2.1 (0.8) | 2.3 (0.8) | 2.2 (0.8) |
| Median (IQR) VLDL cholesterol (mmol/L) | 0.7 (0.5–1.0) | 0.7 (0.5–0.9) | 0.7 (0.5–1.0) |
| HDL cholesterol (mmol/L) | 1.2 (0.4) | 1.1 (0.3) | 1.1 (0.3) |
| Median (IQR) triglycerides (mmol/L) | 1.5 (1.0–2.3) | 1.6 (1.2–2.1) | 1.6 (1.2–2.4) |
| Medication | |||
| N (%) metformin§ | 111 (81.0) | 114 (82.6) | 118 (86.8) |
| N (%) insulin§ | 94 (68.6) | 96 (69.6) | 95 (69.3) |
| N (%) sulfonylurea§ | 39 (28.5) | 40 (29.0) | 37 (27.2) |
| N (%) other antihyperglycaemic drug§ | 17 (12.4) | 17 (12.3) | 25 (18.3) |
| N (%) RAS blockade | 106 (77.4) | 102 (73.9) | 100 (73.0) |
| N (%) other antihypertensive drug | 79 (57.7) | 73 (52.9) | 81 (59.1) |
| N (%) statin | 116 (84.7) | 116 (84.1) | 119 (86.9) |
| N (%) aspirin | 80 (58.4) | 79 (57.3) | 72 (52.6) |
| Carotid ultrasound measures | |||
| Mean carotid IMT (mm) | 0.786 (0.121) | 0.796 (0.148) | 0.798 (0.139) |
| Maximal carotid IMT (mm) | 0.949 (0.140) | 0.954 (0.165) | 0.965 (0.155) |
| Relative compliance×103 (mm/Hg) | 2.5 (1.0) | 2.6 (1.1) | 2.6 (1.1) |
| Incremental elastic modulus (mm Hg) | 2377 (1073) | 2314 (1012) | 2348 (1009) |
| Carotid intima-media area (mm2) | 18.64 (4.10) | 19.28 (5.14) | 19.49 (4.89) |
| Median (IQR) number of plaques¶ | 3 (2–4) | 2 (1–4) | 3 (2–5) |
Values are means (SDs) unless stated otherwise.
*Body mass index is calculated as weight (kg) divided by height (m)2.
†Prior CVD was defined as one or more of the following: myocardial infarction, heart surgery, ischaemic heart disease, heart insufficiency, vascular surgery, stroke, transitory cerebral ischaemia and amputation.
‡Calculated by the Cockcroft-Gault equation: eCCr=((140−age)×weight (kg)×constant)/serum creatinine (μmol/L), constant female: 1.04, male: 1.23.
§All antihyperglycaemic drugs were terminated at randomisation.
¶Sum of plaques in left and right bifurcation, common and internal carotid artery.
CVD, cardiovascular disease; eCCr, estimated creatinine clearance; GAD, glutamic acid decarboxylase; HbA1c, glycated haemoglobin; HDL, high-density lipoprotein; IMT, intima-media thickness; LDL, low-density lipoprotein; RAS, renin angiotensin system; VLDL, very low-density lipoprotein.