Table 1

Main demographic and clinical characteristics of enrolled sample

Case subjectsControl subjectsP
n (male/female)112 (60/52)370 (189/181)0.64
Age (years)68.9 ± 9.968.0 ± 10.00.41
Duration of diabetes (years)8.4 (0.3–20.9)10.0 (0.6–21.0)0.28
BMI (kg/m2)28.1 ± 5.328.2 ± 5.10.78
Weight (kg)75.5 ± 14.275.8 ± 16.50.47
Systolic blood pressure (mmHg)142.5 ± 20.9141.5 ± 21.60.71
Diastolic blood pressure (mmHg)80.4 ± 10.079.8 ± 11.20.42
Alcohol abuse15 (13.4)40 (10.8)0.61
Current smokers25 (22.5)66 (17.8)0.39
CCS2.4 ± 1.42.1 ± 1.10.035
Laboratory parameters
    A1C (%)8.5 ± 1.98.5 ± 1.80.99
    Total cholesterol (mg/dl)195.8 ± 47.3208.9 ± 44.30.029
    HDL cholesterol (mg/dl)47.1 ± 15.352.6 ± 15.50.031
    Triglycerides (mg/dl)143.0 (108.0–93.0)138.0 (95.7–196.2)0.61
    Creatinine (mg/dl)1.1 ± 0.41.1 ± 0.50.99
    Microalbuminuria (μg/ml)13.0 (5.4–44.8)11.0 (5.7–31.0)0.82
Medical history
    Ischemic heart disease30 (26.8)79 (21.4)0.23
    Cerebrovascular disease5 (4.5)25 (6.8)0.38
    Renal failure9 (8.0)26 (7.0)0.72
    Retinopathy10 (8.9)75 (20.3)0.006
    Neuropathy31 (27.7)103 (27.8)0.97
    Foot ulcers3 (2.7)22 (5.9)0.17
    Chronic obstructive pulmonary disease7 (6.3)23 (6.2)0.99
    Any liver disease16 (14.3)27 (7.3)0.10
    Microalbuminuria18 (16.1)68 (18.4)0.58
    Pharmacological therapy at enrollment
    Antihypertensive drugs60 (53.6)212 (57.3)0.58
    Statins30 (26.7)86 (23.2)0.62
    Antiaggregants46 (41.0)155 (41.9)0.81
Oral hypoglycaemic drugs
    Any exposure during the previous 10 years
    Metformin70 (62.5)228 (61.6)0.86
    Insulin secretagogues65 (58.0)199 (53.8)0.48
    Thiazolidinediones1 (0.9)11 (3.0)0.21
Length of exposure during the previous 10 years (months)*
    Metformin27.5 (9.0–61.0)40.0 (13.2–73.76)0.08
    Insulin secretagogues20.2 (5.5–77.5)50.0 (10.5–67.5)0.59
Patients exposed during follow-up
    Any exposure
Human insulin82 (73.2)245 (66.2)0.16
    Basal26 (23.2)74 (20.0)0.46
    Prandial78 (69.6)231 (62.4)0.16
Lispro53 (47.3)184 (49.7)0.65
    Basal1 (0.9)3 (0.8)0.93
    Prandial53 (47.3)180 (48.6)0.80
Aspart9 (8.0)34 (9.2)0.71
    Basal0 (0.0)0 (0.0)
Detemir1 (0.9)13 (3.5)0.14
Glargine29 (26.0)105 (28.4)0.61
MDD (IU/day)*
    Human insulin13.9 (8.0–29.9)17.7 (8.0–29.9)0.40
        Basal11.0 (6.2–19.0)12.1 (6.9–20.9)0.45
        Prandial14.2 (9.1–24.8)16.1 (8.0–33.0)0.83
    Lispro20.1 (10.2–30.2)22.0 (10.5–30.0)0.93
        Basal7.0 (7.0–7.0)3.9 (2.4–33.7)0.71
        Prandial20.1 (8.7–30.2)22.0 (10.5–30.0)0.91
    Aspart16.0 (9.2–24.0)25.2 (15.0–31.4)0.11
    Glargine17.1 (7.0–30.6)12.1 (8.0–18.0)0.08
    Total27.1 (14.0–42.0)27.9 (14.7–43.2)0.71
MDD (IU/kg/day)*
    Human insulin0.19 (0.10–0.38)0.24 (0.11–0.40)0.40
        Basal0.15 (0.09–0.24)0.17 (0.09–0.28)0.86
        Prandial0.21 (0.10–0.36)0.23 (0.11–0.37)0.61
    Lispro0.26 (0.13–0.46)0.30 (0.15–0.43)0.48
        Basal0.12 (0.12–0.12)0.05 (0.03–0.51)0.37
        Prandial0.26 (0.13–0.46)0.30 (0.15–0.43)0.91
    Aspart0.25 (0.11–0.29)0.30 (0.20–0.44)0.33
    Glargine0.24 (0.10–0.39)0.16 (0.12–0.24)0.036
    Total0.35 (0.20–0.59)0.39 (0.20–0.59)0.75
  • Data are expressed as means ± SD, median (interquartile range), or n (%).

  • *In exposed patients.