Table 1—

Patient disposition and characteristics

Liraglutide
All1.90 mg1.25 mg0.65 mgPlacebo
Patient disposition
    Screened377
    Randomized165
    Exposed16341424040
    Withdrawn2563511
        Adverse event72113
        Noncompliance21001
        Ineffective therapy142237
        Other21010
    Completed14037393529
    Included in ITT population16341424040
Baseline characteristics
    Age (years)55.4 ± 11.453.8 ± 10.756.5 ± 9.357.7 ± 8.2
    Sex (male/female) (n)30/1123/1927/1319/21
    BMI (kg/m2)29.9 ± 4.231.2 ± 4.728.9 ± 3.930.4 ± 4.0
    A1C (%)8.5 ± 0.98.3 ± 0.88.1 ± 0.68.2 ± 0.7
    Duration of diabetes (years)4.0 (1–29)7.0 (0–21)6.0 (1–25)5.0 (1–23)
Previous diabetes treatment
    Diet7897
    OAD (metformin)14191517
    OAD (SU)19141615
    OAD (repaglinide)1101
    FPG (mmol/l)12.3 ± 3.111.9 ± 2.411.3 ± 2.711.3 ± 2.2
    Insulin (pmol/l)63 ± 3560 ± 3759 ± 4570 ± 51
Proinsulin (pmol/l)45 ± 2838 ± 1934 ± 2435 ± 20
    Proinsulin-to-insulin ratio0.74 ± 0.260.70 ± 0.300.88 ± 0.520.59 ± 0.33
    Glucagon (pmol/l)23 ± 721 ± 723 ± 919 ± 6
    C-peptide (pmol/l)1138 ± 4551076 ± 4051176 ± 6401260 ± 515
    Fructosamine (μmol/l)360 ± 75341 ± 74358 ± 75330 ± 59
  • Data are means ± SD or median (range) unless otherwise indicated. Data for age, sex, duration of diabetes, and previous treatment were recorded at screening and diabetes characteristics at baseline. Two patients withdrew from the study before receiving study medication; one because of withdrawal of consent and one because of noncompliance. The adverse event withdrawals were as follows: placebo: blood glucose increased (2 patients), hyperglycemia/nausea; 0.65 mg: diarrhea; 1.25 mg: injection site rash; and 1.90 mg: tachypnoea/gastrooesophageal reflux disease, constipation. ITT, intent to treat.