Table 1

Baseline characteristics of the patient population

CharacteristicsIntervention (n=45)Control (n=45)
Age at randomization, median (IQR)58.5 (50.1–64.2)56.1 (51.0–64.5)
Sex, n (%)
 Male20 (44.4)19 (42.2)
 Female25 (55.6)26 (57.8)
Ethnicity, n (%)
 Caucasian26 (57.8)27 (60.0)
 Mixed1 (2.2)1 (2.2)
 Asian4 (8.9)7 (15.6)
 Black14 (1.1)10 (22.2)
Weight (kg), mean (SD)104.0 (20.2)103.1 (18.9)
Body mass index (kg/m²), mean (SD)36.6 (5.1)36.8 (5.3)
Waist circumference (cm), mean (SD)120.3 (12.7)121.5 (12.4)
Hip circumference (cm), mean (SD)120.7 (12.1)122.0 (13.2)
Waist-to-hip ratio, mean (SD)1.00 (0.06)1.00 (0.06)
Body fat (%), mean (SD)40.4 (8.0)40.4 (7.4)
HbA1c (%), mean (SD)8.7 (1.7)9.3 (1.7)
Duration of diabetes, median (IQR)13.0 (9.0–20.0)12.0 (6.0–18.0)
HbA1c (mmol/mol)72.2 (19.0)78.4 (18.7)
Fasting glucose (mmol/L)10.10 (3.76)10.61 (3.02)
Insulin (U), median (IQR)73.1 (41.3)79.4 (70)
Insulin (U/kg), median (IQR)0.72 (0.42)0.75 (0.51)
Duration of insulin, median (IQR)4.0 (2.0 to 6.2)4 (2.5 to 8.0)
Other medications, n (%)
 Metformin37 (82.2)42 (93.3)
 SU10 (22.2)16 (35.6)
 GLP-114 (31.1)3 (6.7)
 Dipeptidyl peptidase IV inhibitors5 (11.1)7 (15.6)
 SGLT-2 inhibitors7 (15.6)4 (8.9)
 Thiazolidinediones0 (0)1 (2.2)
Oral antidiabetic medications, n2.62 (0.94)2.6 (0.83)
Blood pressure (mm Hg), mean (SD)
 Systolic131.5 (16.1)132.2 (17.6)
 Diastolic73.2 (9.1)74.0 (12.7)
HDL cholesterol (mmol/L)1.09 (0.30)1.14 (0.35)
Triglycerides (mmol/L)2.01 (2.14)1.78 (1.41)
Hypertension, n (%)32 (80.0)35 (77.8)
CHD, n (%)9 (22.5)12 (26.7)
Smoking, n (%)8 (17.8)7 (15.6)
Statins, n (%)40 (88.9)41 (91.1)
Retinopathy, n (%)19 (42.2)16 (35.6)
Nephropathy, n (%)6 (13.3)12 (26.7)
Neuropathy, n (%)10 (25.0)17 (40.0)
Estimated glomerular filtration rate (mL/min/1.73 m2)75.4 (17.1)76.9 (21.4)
Quality of life (mm)68.1 (19.9)62.7 (19.4)
  • Data presented as mean (SD), n (%) or median (IQR) unless otherwise specified.

  • No significant difference between groups in any characteristics.

  • Nephropathy defined as having estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2.

  • CHD, Coronary Heart Disease; GLP-1, glucagon-like peptide-1 agonist; HbA1c, glycated hemoglobin; HDL, high-density lipoprotein; SGLT-2, sodium-glucose cotransporter-2 inhibitor; SU, sulfonylurea.