Table 1—

Characteristics of enrolled population and subject disposition

Once-daily liraglutide
Once-daily 4 mg glimepiridePlacebo
0.6 mg1.2 mg1.8 mg
Sex: male/female (%)62/3854/4659/4157/4360/40
Age (years)56 ± 1157 ± 957 ± 957 ± 956 ± 9
Race: C/B/A/O (%)84/2/13/288/4/8/188/2/7/289/2/9/188/3/7/3
BMI (kg/m2)30.5 ± 4.831.1 ± 4.830.9 ± 4.631.2 ± 4.631.6 ± 4.4
Duration of diabetes (years)7 ± 57 ± 58 ± 58 ± 58 ± 6
Prestudy OAD treatment
    Monotherapy81 (34)91 (38)83 (34)89 (37)41 (34)
        Metformin70 (86)78 (86)72 (87)82 (92)38 (93)
        Sulfonylurea9 (11)12 (13)11 (13)7 (8)3 (7)
        Repaglinide2 (3)1 (1)000
    Combination therapy161 (67)150 (62)159 (66)155 (63)81 (66)
A1C (%)8.4 ± 0.98.3 ± 1.08.4 ± 1.08.4 ± 1.08.4 ± 1.1
FPG (mmol/l)10.2 ± 2.49.9 ± 2.310.1 ± 2.310.0 ± 2.610.0 ± 2.3
SBP (mmHg)131 ± 14132 ± 14131 ± 14132 ± 16135 ± 16
DBP (mmHg)80 ± 880 ± 1079 ± 880 ± 881 ± 9
Randomized242241242244122
Exposed (ITT and safety populations)242240242242121
Completers208 (86)197 (82)191 (79)210 (86)74 (61)
Withdrawals34 (14)44 (18)51 (21)34 (14)48 (39)
    Adverse events11 (5)23 (10)29 (12)8 (3)2 (2)
    Nausea/vomiting/diarrhea3 (1)13 (5)20 (8)00
    Ineffective therapy19 (8)8 (3)13 (5)9 (4)29 (24)
    Noncompliance2 (1)4 (2)4 (2)5 (2)4 (3)
    Other2 (1)9 (4)5 (2)12 (5)13 (11)
  • Data are means ±SD or n (%) unless otherwise noted. *Race: C, Caucasian; B, Black; A, Asian /Pacific Islander; O, other. DBP, diastolic blood pressure; ITT, intention to treat.