Baseline demographic and clinical characteristics (mITT population, n=808)
| OADs only n=335 | BI n=473 | Overall n=808 | |
| Age (years) | |||
| Mean±SD | 61.8±8.5 | 63±8.1 | 62.5±8.3 |
| Range | 40.0–84.0 | 35.0–82.0 | 35.0–84.0 |
| Median | 63.0 | 64.0 | 64.0 |
| IQR* | 56.0–68.0 | 57.0–69.0 | 57.0–69.0 |
| Gender | |||
| Women, n (%) | 184 (54.9) | 278 (58.8) | 462 (57.2) |
| Weight (kg) | |||
| Mean±SD | 89.4±15.2 | 90.8±16.4 | 90.2±15.9 |
| Median | 87.0 | 89.0 | 88.0 |
| IQR | 80.0–98.0 | 80.0–99.0 | 80.0–98.0 |
| BMI (kg/m2) | |||
| Mean±SD | 32.2±5.2 | 32.6±5.3 | 32.4±5.3 |
| Median | 31.6 | 31.8 | 31.8 |
| IQR | 28.7–34.9 | 28.7–35.4 | 28.7–35.3 |
| Diabetes duration (years) | |||
| Mean±SD | 9.3±4.6 | 11.0±6.3 | 10.3±5.7 |
| Median | 9.0 | 10.0 | 10.0 |
| IQR | 5.0–13.0 | 6.0–15.0 | 6.0–13.0 |
| HbA1c (%) | |||
| Mean±SD | 9.6±1.4 | 8.8±1.2 | 9.2±1.4 |
| Median | 9.5 | 8.6 | 9.0 |
| IQR | 8.6–10.3 | 8.0–9.5 | 8.2–9.9 |
| FPG† (mmol/L) | |||
| Mean±SD | 11.9±3.1 | 10.0±2.5 | 10.8±2.9 |
| Median | 11.3 | 9.7 | 10.3 |
| IQR | 10.0–13.5 | 8.3–11.1 | 8.9–12.2 |
| Diabetes complications/comorbidities, n (%) | |||
| Neuropathy | 170 (50.7) | 274 (57.9) | 444 (55.0) |
| Retinopathy | 32 (9.6) | 70 (14.8) | 102 (12.6) |
| Chronic kidney disease | 14 (4.2) | 47 (9.9) | 61 (7.5) |
| Ischaemic heart disease | 102 (30.4) | 166 (35.1) | 268 (33.2) |
| Peripheral artery disease | 29 (8.7) | 63 (13.3) | 92 (11.4) |
| Obesity | 232 (69.3) | 360 (76.1) | 592 (73.3) |
| Hypertension | 252 (75.2) | 394 (83.3) | 646 (80.0) |
| Dyslipidaemia | 243 (72.5) | 378 (79.9) | 621 (76.9) |
| Diabetes treatment at baseline, n (%) | |||
| Metformin | 335 (100.0) | 473 (100.0) | 808 (100) |
| Sulfonylureas | 217 (64.8) | 3 (0.6) | 220 (27.2) |
| DPP-4 inhibitors | 23 (6.9) | 0 (0.0) | 23 (2.8) |
| SGLT-2 inhibitors | 16 (4.8) | 0 (0.0) | 16 (2) |
| Meglitinides | 2 (0.6) | 0 (0.0) | 2 (0.2) |
| BI | 0 (0) | 473 (100) | 473 (58.5) |
*IQR: Q1–Q3.
†FPG reported for the PP population (n=800).
BI, basal insulin; BMI, body mass index; DPP-4, dipeptidyl peptidase-4; FPG, fasting plasma glucose; HbA1c, glycated haemoglobin; mITT, modified intention-to-treat; OADs, oral antidiabetic drugs; PP, per-protocol; SGLT-2, sodium glucose co-transporter-2.