Table 5 Analysis of risk factors for hypoglycaemia, urinary tract infection and genital tract infection (safety analysis set)

Hypoglycaemia

 Age (>65 years vs 18–65 years)

2985

0.682 (0.206–2.260)

0.531

0.526 (0.107–2.573)

0.428

 Sex (female vs male)^b

2986

0.913 (0.413–2.017)

0.821

1.254 (0.445–3.533)

0.669

 BMI (vs ≥18.5 and <24)

2852

  ≥24 and <28

0.920 (0.350–2.421)

0.866

0.591 (0.162–2.149)

0.424

  ≥28

0.715 (0.248–2.064

0.536

0.847 (0.230–3.129)

0.804

 Diabetes duration (per increase of 1 year)

2928

1.064 (1.020–1.109)

0.004

–

–

 Diabetes duration (vs ≤ 5 years)

  >5 and ≤10 years

9.317 (2.065–42.035)

0.004

3.530 (0.670–18.593)

0.137

  >10 and ≤20 years

4.893 (1.039–23.054)

0.045

2.418 (0.437–13.376)

0.312

  >20 years

14.995 (3.108–72.349)

<0.001

5.932 (0.962–36.557)

0.055

 Presence of T2DM complications (yes vs no)^c,d

2986

1.451 (0.656–3.208)

0.358

1.212 (0.369–3.981)

0.751

 eGFR (1 ml/min/1.73 m²) (vs ≥90)

1763

  ≥60 and <90

1.743 (0.568–5.350)

0.331

1.697 (0.528–5.455)

0.375

  <60

0.000 (0.000–NE)

0.991

0.000 (0.000–NE)

0.990

 Concomitant anti-diabetes medications (vs ≤1)

2986

  2

1.426 (0.429–4.735)

0.562

3.038 (0.337–27.406)

0.322

  ≥3

2.647 (0.885–7.919)

0.082

2.318 (0.219–24.577)

0.485

 Insulin use (yes vs no)^c

2986

1.882 (0.890–3.979

0.098

1.760 (0.594–5.218)

0.308

 Sulfonylurea use (yes vs no)

2986

1.841 (0.850–3.989)

0.122

1.303 (0.365–4.658)

0.684

 Metformin use (yes vs no)

2986

1.792 (0.681–4.714)

0.237

1.292 (0.320–5.222)

0.719

 Presence of ASCVD (yes vs no)

2986

0.967 (0.391–2.388)

0.942

1.821 (0.637–5.206)

0.263

Urinary tract infection

 Age (>65 years vs 18–65 years)

2986

1.023 (0.522–2.004)

0.947

1.007 (0.322–3.151)

0.991

 Sex (female vs male)^b

2987

2.274 (1.406–3.678)

<0.001

2.244 (1.047–4.810)

0.038

 BMI (vs ≥18.5 and <24)

2853

  ≥24 and <28

1.782 (0.823–3.860)

0.143

1.483 (0.483–4.551)

0.491

  ≥28

1.642 (0.737–3.658)

0.225

1.468 (0.455–4.741)

0.521

 Diabetes duration (per increase of 1 year)

2929

1.015 (0.983–1.048)

0.367

–

–

 Diabetes duration (vs ≤5 years)

   >5 and ≤10 years

1.053 (0.552–2.007)

0.876

1.556 (0.580–4.178)

0.380

   >10 and ≤20 years

0.985 (0.543–1.785)

0.959

1.303 (0.487–3.485)

0.598

   >20 years

1.240 (0.533–2.882)

0.618

0.818 (0.159–4.210)

0.810

 Presence of T2DM complications (yes vs no)^c,d

2987

1.073 (0.656–1.755)

0.780

1.025 (0.439–2.392)

0.954

 HbA_1c % (per increase of 1%)

1609

1.035 (0.882–1.214)

0.675

1.010 (0.781–1.306)

0.940

 FPG (per increase of 1 mmol/L)

1823

1.023 (0.945–1.108)

0.568

1.054 (0.923–1.204)

0.438

 eGFR (1 ml/min/1.73 m²) (vs ≥90)

1763

  ≥60 and <90

1.479 (0.680–3.219)

0.324

1.387 (0.507–3.796)

0.524

   < 60

0.000 (0.000–NE)

0.986

0.000 (0.000–NE)

0.989

Genital tract infection

 Age (> 65 years vs 18–65 years)

2984

0.780 (0.275–2.215)

0.641

0.757 (0.153–3.738)

0.733

 Sex (female vs male)^b

2985

4.006 (1.951–8.229)

 <0.001

6.723 (2.135–21.167)

0.001

 BMI (vs ≥18.5 and <24)

2851

  ≥24 and <28

1.475 (0.405–5.371)

0.556

2.543 (0.344–18.790)

0.360

  ≥28

3.678 (1.091–12.395)

0.036

6.701 (0.948–47.380)

0.057

 Diabetes duration (per increase of 1 year)

2927

1.039 (0.996–1.084)

0.076

–

–

 Diabetes duration (vs ≤5 years)

   >5 and ≤10 years

1.698 (0.674–4.278)

0.262

6.107 (1.212–30.785)

0.028

   >10 and ≤20 years

1.158 (0.457–2.935)

0.756

4.184 (0.743–23.560)

0.105

   >20 years

2.824 (1.003–7.954)

0.049

20.580 (3.448–122.828)

 < 0.001

 Presence of T2DM complications (yes vs no)^c,d

2985

0.321 (0.156–0.659)

0.002

0.153 (0.048–0.481)

0.001

 HbA_1c % (per increase of 1%)

1609

0.878 (0.692–1.115)

0.286

1.101 (0.771–1.572)

0.597

 FPG (per increase of 1 mmol/L)

1823

0.971 (0.863–1.093)

0.626

0.897 (0.724–1.112)

0.322

 eGFR (1 ml/min/1.73 m²) (vs ≥90)

1764

  ≥60 and <90

0.203 (0.026–1.621)

0.133

0.298 (0.037–2.432)

0.258

  <60

0.000 (0.000–NE)

0.990

0.000 (0.000–NE)

0.992