Table 1—

Baseline characteristics and patient disposition of the ITT populations for the 12-week core and extension studies*

Randomized for 12-week study
Extension population
LAF/METPBO/METLAF/METPBO/MET
n56514229
Age (years)57.9 ± 10.055.7 ± 11.058.4 ± 9.254.3 ± 12.2
Sex (male)39 (69.6)34 (66.7)26 (61.9)22 (75.9)
BMI (kg/m2)29.4 ± 3.630.2 ± 3.629.6 ± 3.729.9 ± 3.6
Duration of diabetes (years)5.6 ± 4.25.5 ± 3.75.8 ± 4.24.6 ± 3.6
Duration of previous MET treatment (months)28.2 ± 25.629.8 ± 36.128.7 ± 24.023.7 ± 25.1
HbA1c (%)7.7 ± 0.67.8 ± 0.77.6 ± 0.67.8 ± 0.6
FPG (mmol/l)9.9 ± 2.010.3 ± 2.09.6 ± 1.610.1 ± 1.8
Hypertension28 (50.0)27 (52.9)25 (59.5)13 (44.8)
Discontinued6 (10.7)4 (7.8)10 (23.8)3 (10.3)
    Adverse event003 (7.1)0
    Abnormal laboratory value1 (1.8)01 (2.4)0
    Unsatisfactory therapeutic effect1 (1.8)1 (2.0)3 (7.1)2 (6.9)
    Protocol violation1 (1.8)1 (2.0)2 (4.8)1 (3.4)
    Withdrew consent1 (1.8)1 (2.0)00
    Lost to follow-up1 (1.8)000
    Administrative problems1 (1.8)01 (2.4)0
    Abnormal test procedure results01 (2.0)00
  • Data are means ± SD and n (%).

  • *

    * One patient in the randomized LAF/MET group was Asian, all other participants were Caucasian.

  • Adverse events leading to discontinuation were worsening of hypertension, moderate, not suspected to be related to study medication; first-degree atrioventricular block, mild, suspected to be related to study medication; and moderate peripheral edema suspected to be related to study medication.

  • As judged by the investigator. LAF/MET, LAF237 plus metformin group; PBO/MET, placebo plus metformin group.