Table 1—

Patient disposition randomization*

Usual titration and laboratory A1CUsual titration and POC A1CActive titration and laboratory A1CActive titration and POC A1C
n1,9781,9751,9671,973
Did not start insulin46394737
No data beyond visit 140262429
Safety population§1,8921,9101,8961,909
Modified ITT population1,7741,7641,7651,763
Reason for discontinuation
    Death4 (1.0)9 (2.5)7 (1.9)6 (1.6)
    Adverse events24 (6.2)29 (7.9)25 (6.9)20 (5.3)
    Failed entry criteria28 (7.2)37 (10.1)30 (8.3)34 (9.1)
    Withdrew consent74 (19.1)69 (18.9)73 (20.1)66 (17.6)
    Treatment failure21 (5.4)21 (5.8)17 (4.7)18 (4.8)
    Protocol violation19 (4.9)9 (2.5)20 (5.5)23 (6.1)
    Lost to follow-up60 (15.5)57 (15.6)35 (9.6)46 (12.3)
    Other reason59 (15.2)48 (13.2)60 (16.5)63 (16.8)
    No reason98 (25.3)86 (23.6)96 (26.4)98 (26.2)
Population completing1,5911,6101,6041,599
Primary analysis population#1,4911,3631,5011,366
  • Data are n or n (%). N = 7,893.

  • * All patients were randomized by the interactive voice response system.

  • All randomized patients who did not take study medication because they did not meet the inclusion/exclusion criteria.

  • Patients who took the study medication but only had data for visit 1.

  • § All patients who were randomized, who took the study medication, and for whom there was an opportunity to collect safety data.

  • All patients who were randomized, who were included in the safety analysis population, and who either 1) had a blood glucose measurement at visit 1 before randomization and another after the start of study medication but not more than 2 days after the end of study medication or 2) had an A1C measurement performed at an outside laboratory at visit 1 and another after the start of study medication but not more than 7 days after the end of study medication.

  • Patients in the modified ITT population who completed the study.

  • # Patients in the modified ITT population who completed the study and had both baseline and end-of-study laboratory A1C values.