Table 1—

Demographics, baseline values, and completion status

Insulin plus metforminTriple oral therapyP
Subjects randomized (n)9098
Age (years)54 ± 9.354 ± 10.80.118
Sex (F/M)44 (52)/41 (48)50 (51)/48 (49)0.990
Race
  African American13 (15)11 (11)0.858
  Caucasian61 (72)74 (76)
  Other11 (13)13 (13)
Weight (kg)97 ± 20.698 ± 18.80.328
BMI (kg/m2)33 ± 6.034 ± 5.40.948
Duration diabetes (years)10.4 ± 6.98.9 ± 5.70.548
FPG at screening (mg/dl)220 ± 55.9218 ± 53.40.352
A1C at screening (%)9.7 ± 1.69.6 ± 1.30.774
Subjects randomized90 (100)98 (100)
Subjects treated85 (94)98 (100)
Subjects completed79 (88)88 (90)
Discontinued before treatment5 (6)0
Discontinued during treatment6 (7)10 (10)
  Reasons for discontinuation
    Adverse event1 (1)3 (3)
    Noncompliance with protocol1 (1)1 (1)
    Other4 (4)6 (6)
Switched before week 242 (2)10 (10)
Switched at week 2403 (3)
  • Data are means ± SD and n (%).

  • Five subjects did not initiate treatment (one subject moved out of state due to family illness, one subject had dramatically improved blood glucose values before starting study therapy [final A1C 7.0%], and three subjects withdrew consent);

  • includes discontinuation due to withdrawal of consent, time constraints, unable to follow-up, patient moved to another city, or weight gain.