Table 1

Baseline and end of BIO-phase characteristics of the study population

CharacteristicEnrolledRespondersFailures
(n = 917)(n = 92)(n = 652)
Demographic
 Men457 (50%)56 (61%)315 (48%)
 Age (years), mean (SD) 59.8 (9.5)57.4 (8.9)59.7 (9.4)
 Duration of diabetes (years), median (IQR)12 (8–16)10 (6–14)12 (8–16)
 Ethnic origin
  White809 (88%)79 (86%)568 (87%)
  Asian49 (5%)5 (5%)37 (6%)
  African American5 (<1%)0 (0%)3 (<1%)
  Other*53 (6%)8 (9%)43 (7%)
Clinical
 Use of glucose-lowering medication
  Metformin daily dose (mg), mean (SD) 2,027 (655)2,037 (703)2,010 (648)
  Insulin glargine (units/day), mean (SD)
   Start of BIO-phase40.7 (24.2)34.5 (17.0)40.6 (24.2)
   End of BIO-phase56.8 (30.5)47.3 (22.2)58.0 (31.0)
  Insulin glargine (units/day), median (IQR)
   Start of BIO-phase34 (24–46)30 (24–40)34 (25–46)
   End of BIO-phase48 (38–70)41 (31–56)50 (38–70)
 Glycemic measures
  HbA1c (%) [mmol/mol], mean (SD)
   Start of BIO-phase8.5 (1.0) [69 (10.9)]7.9 (0.7) [63 (7.7)]8.6 (0.8) [70 (8.7)]
   End of BIO-phase8.2 (1.0) [66 (10.9)]6.7 (0.4) [50 (4.4)]8.4 (0.9) [68 (9.8)]
  FG (mmol/L), mean (SD)
   Start of BIO-phase8.4 (2.8)7.1 (2.2)8.6 (2.8)
   End of BIO-phase7.2 (2.4)5.9 (1.7)7.3 (2.4)
 Anthropometric measures
  Body weight (kg), mean (SD)
   Start of BIO-phase88.9 (17.4)89.4 (18.1)88.9 (16.9)
   End of BIO-phase89.3 (17.1)90.1 (17.5)89.3 (17.0)
  BMI (kg/m2), mean (SD)
   Start of BIO-phase32.1 (5.0)31.8 (4.7)32.2 (4.8)
   End of BIO-phase32.3 (4.8)31.5 (4.5)32.3 (4.8)
  Blood pressure (mmHg), mean (SD)
   Systolic
    Start of BIO-phase138 (16)137 (18)137 (15)
    End of BIO-phase
   Diastolic
    Start of BIO-phase80 (10)80 (10)79 (10)
    End of BIO-phase
  Pulse rate (beats per min), mean (SD)
   Start of BIO-phase76 (11)77 (11)75 (11)
   End of BIO-phase
  • Enrolled, patients who enrolled in the BIO-phase; responders, patients at the end of the BIO-phase who had HbA1c of 7% or less after 12 weeks of titrated insulin glargine; failures, patients at the end of the BIO-phase who had HbA1c >7% and who were eligible to enroll in the intervention phase of the study.

  • *American Indian or Native Alaskan.

  • †As-treated population.