Table 1.
Baseline characteristics
| Variable | Total cohort | Dapagliflozin | Placebo | P-value |
|---|---|---|---|---|
| Participants randomized | 66 | 32 | 34 | |
| Demographics | ||||
|
Age (years) |
65.53 ± 6.87 | 64.25 ± 7.01 | 66.74 ± 6.62 | 0.143 |
| Male | 38 (57.6%) | 20 (62.5%) | 18 (52.9%) | 0.432 |
| Never smoked | 31 (47.0%) | 14 (43.8%) | 17 (50.0%) | 0.611 |
| Current smoker | 4 (6.1%) | 3 (9.4%) | 1 (2.9%) | 0.348 |
| Ex—smoker | 31 (47.0%) | 15 (46.9%) | 16 (47.1%) | 0.988 |
| Duration of diabetes (years)a | 10.0 (6.0, 15.0) | 8.5 (5.25, 14.5) | 10.0 (7.5, 15.0) | 0.343 |
| Weight (kg) | 91.53 ± 14.26 | 91.58 ± 14.62 | 91.48 ± 14.13 | 0.977 |
| BMI (kg/m2) | 32.45 ± 4.41 | 32.30 ± 4.66 | 32.59 ± 4.22 | 0.793 |
| Co-morbidities | ||||
| IHD | 8 (12.1%) | 2 (6.3%) | 6 (17.6%) | 0.260 |
| Hypertension | 51 (77.3%) | 26 (81.3%) | 25 (73.5%) | 0.454 |
| Stroke | 7 (10.6%) | 1 (3.1%) | 6 (17.6%) | 0.106 |
| Hypercholesterolaemia | 38 (57.6%) | 17 (53.1%) | 21 (61.8%) | 0.478 |
| Medications | ||||
| Ace inhibitor | 35 (53.0%) | 17 (53.1%) | 18 (52.9%) | 0.988 |
| Angiotensin receptor blocker | 11 (16.7%) | 5 (15.6%) | 6 (17.6%) | 0.826 |
| Calcium channel blocker | 22 (33.3%) | 9 (28.1%) | 13 (38.2%) | 0.384 |
| Thiazide diuretic | 13 (19.7%) | 9 (28.1%) | 4 (11.8%) | 0.095 |
| Beta-blocker | 9 (13.6%) | 4 (12.5%) | 5 (14.7%) | 0.794 |
| Alpha-blocker | 7 (10.6%) | 4 (12.5%) | 3 (8.8%) | 0.705 |
| Aspirin | 10 (15.2%) | 4 (12.5%) | 6 (17.6%) | 0.734 |
| Clopidogrel | 7 (10.6%) | 2 (6.3%) | 5 (14.7%) | 0.428 |
| Statin | 55 (83.3%) | 25 (78.1%) | 30 (88.2%) | 0.271 |
| Metformin | 66 (100.0%) | 32 (100.0%) | 34 (100.0%) | Constant |
| Sulphonlylurea | 15 (22.7%) | 7 (21.9%) | 8 (23.5%) | 0.873 |
| DDP-IV inhibitor | 7 (10.6%) | 4 (12.5%) | 3 (8.8%) | 0.705 |
| GLP-1 agonist | 7 (10.6%) | 4 (12.5%) | 3 (8.8%) | 0.705 |
| Thiazolidinedione | 3 (4.5%) | 0 (0.0%) | 3 (8.8%) | 0.239 |
| Insulin | 14 (21.2%) | 7 (21.9%) | 7 (20.6%) | 0.898 |
| Blood pressure | ||||
| 24 h SBP baselineb | 129.02 ± 10.09 | 130.41 ± 9.62 | 127.67 ± 10.65 | 0.281 |
| (n = 65) | (n = 33) | |||
| 24 h DBP baselineb | 73.42 ± 7.04 | 74.41 ± 7.88 | 72.46 ± 6.09 | 0.267 |
| (n = 65) | (n = 33) | |||
| Heart rate baselinec | 75.31 ± 13.91 | 74.44 ± 13.9 | 76.15 ± 14.08 | 0.623 |
| (n = 65) | (n = 33) | |||
| Daytime SBP baselineb | 131.43 ± 10.74 | 132.59 ± 10.37 | 130.30 ± 11.19 | 0.394 |
| (n = 65) | (n = 33) | |||
| Daytime DBP baselineb | 75.37 ± 7.37 | 76.44 ± 8.57 | 74.33 ± 5.94 | 0.253 |
| (n = 65) | (n = 33) | |||
| Nocturnal SBP baselined | 120.50 ± 12.06 | 123.84 ± 11.1 | 119.81 ± 12.8 | 0.183 |
| (n = 64) | (n = 32) | |||
| Nocturnal DBP baselined | 67.50 ± 7.77 | 68.97 ± 7.84 | 66.00 ± 7.52 | 0.127 |
| (n = 64) | (n = 32) | |||
| Office SBP baseline | 136.68 ± 8.32 | 137.25 ± 7.5 | 136.15 ± 9.11 | 0.594 |
| Office DBP baseline | 78.45 ± 8.4 | 79.16 ± 8.63 | 77.79 ± 8.25 | 0.514 |
| Laboratory measurements | ||||
| Haemoglobin (g/L) | 138.36 ± 12.72 | 138.31 ± 13.61 | 138.41 ± 12.03 | 0.514 |
| Haematocrit (%) | 41.73 ± 3.31 | 41.46 ± 3.30 | 41.99 ± 3.35 | 0.975 |
| Creatinine (umol/L) | 68.11 ± 18.38 | 65.09 ± 16.36 | 70.94 ± 19.92 | 0.199 |
| GFR (mL/min/1.732) | 101.88 ± 27.06 | 107.53 ± 25.40 | 96.56 ± 27.86 | 0.100 |
| Sodium (mmol/L) | 138.92 ± 2.24 | 138.72 ± 2.16 | 139.12 ± 2.33 | 0.474 |
| Potassium (mmol/L) | 4.34 ± 0.35 | 4.23 ± 0.32 | 4.44 ± 0.35 | 0.013 |
| Fasting glucose (mmol/L) | 8.05 ± 2.96 | 7.80 ± 3.50 | 8.05 ± 3.00 | 0.964 |
| Fasting insulin (uIU/mL)a,e | 11.08 | 10.56 | 11.38 ± 11.42 | 0.521 |
| (n = 48) | (7.43, 18,93) | (6.30, 18.99) | (7.90, 19.320 | |
| (n = 22) | (n = 26) | |||
| HOMA-IRa,e | 4.03 | 4.03 ± 4.26 | 3.91 | 0.756 |
| (n = 48) | (2.75, 6.78) | (2.41, 6.67) | (2.96, 7.37) | |
| (n = 22) | (n = 26) | |||
| HbA1c (mmol/mol) | 60.94 ± 10.61 | 61.75 ± 11.19 | 60.18 ± 10.15 | 0.551 |
| NT-proBNP (pg/mL)a | 274.42 | 217.98 | 365.03 | 0.218 |
| (116.12, 568.45) | (82.93, 560.56) | (144.86, 678.12) | ||
| Leptin (pg/mL)a | 15.65 | 13.12 | 17.92 | 0.124 |
| (7.48, 30.75) | (5.69, 29.10) | (10.71, 38.94) | ||
| Myeloperoxidase (ng/mL)a | 117.66 | 129.14 | 114.37 | 0.837 |
| (64.83, 246.42) | (59.74, 278.11) | (65.03, 216.40) | ||
| NT pro collagen III (ng/mL)a | 16.60 | 15.91 | 17.25 | 0.878 |
| (13.42, 20.74) | (13.69, 21.59) | (13.10, 20.74) | ||
| hsCRP (ng/mL)a | 1696.30 | 1168.55 | 2225.01 | 0.349 |
| (687.10, 3966.83) | (635.62, 4685.52) | (795.84, 3966.83) |
Data are mean ± SD, n (%).
BSA, body surface area; DBP, diastolic blood pressure; DDP-IV; dipeptidyl peptidase-4; GFR, glomerular filtration rate; GLP-1, glucagon like peptide; HDL, high-density lipoprotein; HOMA-IR, homeostatic model assessment of insulin resistance; hsCRP, high sensitive C-reactive protein; IHD, ischaemic heart disease; LDL, low-density lipoprotein; NT-proBNP, N-terminal pro natriuretic peptide; SBP, systolic blood pressure.
a
Median (quartile 1, quartile 3).
b
One patient unable to tolerate ABPM.
c
Heart rate taken from ambulatory 24-h recording.
d
Further patient unable to tolerate nocturnal ABPM.
e
Only performed on people not on insulin.