Table 3:
Baseline characteristics and demographics.
| Characteristics | Values |
|---|---|
| Total randomised population, N | 3534 |
| Age (years) | 66.6 (9.0) |
| Male, n (%) | 2464 (69.7) |
| Race, n (%) White Black or African American Asian American Indian or Alaska Native Hawaiian or other Pacific Islander Other Not reported |
2323 (65.7) 160 (4.5) 846 (23.9) 25 (0.7) 5 (0.1) 96 (2.7) 79 (2.2) |
| Ethnicity, n (%) Hispanic or Latino Not Hispanic or Latino Not reported |
556 (15.7) 2833 (80.2) 145 (4.1) |
| Region, n (%) Europe Asia North America South America Africa Other |
962 (27.2) 913 (25.8) 865 (24.5) 252 (7.1) 101 (2.9) 441 (12.5) |
| Systolic BP (mmHg) | 138.6 (15.8) |
| Diastolic BP (mmHg) | 76.4 (10.0) |
| Pulse (bpm) | 73.1 (11.3) |
| Body mass index (kg/m2) | 32.0 (6.3) |
| Body weight (kg) | 89.6 (20.5) |
| HbA1c (%) | 7.8 (1.3) |
| HbA1c (mmol) | 61.5 (14.1) |
| HbA1c >7%, n (%) | 2424 (68.6) |
| T2D duration, years | 17.4 (9.3) |
| eGFR (ml/min/1.73 m2)a | 47.0 (15.2) |
| eGFR <60 ml/min/1.73 m2, n (%) | 2814 (79.6) |
| UACR (mg/g), median (range) | 568 (2–11 852) |
| Macroalbuminuria (UACR ≥300 mg/g), n (%) | 2419 (68.4) |
| Diabetic neuropathy, n (%)b | 1521 (43.0) |
| Diabetic retinopathy in worst eye, n (%)c Mild non-proliferative Moderate–severe non-proliferative Proliferative |
1585 (44.9) 943 (26.7) 436 (12.3) 204 (5.8) |
| Diabetic macular oedema in worst eye, n (%)c | 240 (6.8) |
| Previous cardiovascular diseasec Previous MI Previous stroke Heart failure |
1838 (52.0) 513 (14.5) 367 (10.4) 675 (19.1) |
| Very high CKD progression risk (KDIGO criteria), n (%)d | 2413 (68.2) |
| Oral anti-diabetes drugs at baseline, n
(%) Metformine Sulphonylurea DPP-4i SGLT2i Thiazolidinedione Alpha-glucosidase inhibitors |
1825 (51.6) 879 (24.9) 898 (25.4) 548 (15.5) 147 (4.2) 109 (3.1) |
| Insulin at baseline, n (%) Long acting Short acting Premixed |
2172 (61.5) 1616 (45.7) 1293 (36.6) 224 (6.3) |
| RAAS inhibitors, n (%) | 3368 (95.3) |
| Cardiovascular medications, n (%) Beta blockers ACE inhibitors Angiotensin receptor blockers Calcium channel blockers Angiotensin receptor–neprilysin inhibitor |
3511 (99.3) 1823 (51.6) 1242 (35.1) 2127 (60.2) 1992 (56.4) 24 (0.68) |
| Lipid-lowering drugs, n (%) Statins Bile acid sequestrants Fibrates Ezetimibe PCSK-9 inhibitors Eicosapentaenoic acid ethyl ester Omega-3-acid ethyl ester Other omega 3-triglycerides |
2799 (79.2) 2655 (75.1) 1 (0.03) 302 (8.5) 248 (7.0) 9 (0.3) 22 (0.6) 12 (0.3) 64 (1.8) |
All values are mean (SD) unless stated otherwise.
As the trial is ongoing, data may be subject to minor changes until database lock.
aeGFR was estimated using the CKD-EPI equation.
bBased on medical history.
cBased on eye examination at baseline, verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation; eye examination performed by a suitably qualified healthcare provider (e.g. optometrist or ophthalmologist).
dDefined as (i) UACR (mg/g) <30 and eGFR (mL/min/1.73 m2) ≤15 to <30, (ii) UACR (mg/g) ≤30 to <300 and eGFR (mL/min/1.73 m2) ≤30 to <45, (iii) UACR (mg/g) ≤30 to <300 and eGFR (mL/min/1.73 m2) ≤15 to <30, (iv) UACR (mg/g) ≤300 and eGFR (mL/min/1.73 m2) ≤45 to <60, (v) UACR (mg/g) ≤300 and eGFR (mL/min/1.73 m2) ≤30 to <45 or (vi) UACR (mg/g) ≤300 and eGFR (mL/min/1.73 m2): ≤15 to <30.
eRelatively low proportion of patients due to metformin being contraindicated in participants with a low eGFR.
ACE, angiotensin-converting enzyme; BP, blood pressure; bpm, beats per minute; DPP-4i, dipeptidyl peptidase-4 inhibitor; MI, myocardial infarction; n, number of participants; PCSK-9, proprotein convertase subtilisin/kexin type 9.