Table 2.
Primary and Secondary Outcomes
DPP-4i | DPP-4i + basal | Basal-bolus | P value | |
---|---|---|---|---|
Number of patients | 144 | 158 | 283 | |
Mean hospital daily BG, mg/dL | 171 ± 39 | 171 ± 42 | 172 ± 45 | .94 |
Treatment failure, n (%) | 24 (17%) | 25 (16%) | 39 (14%) | .7 |
% BG within target, 70–180 mg/dL | 63 ± 32 | 60 ± 31 | 64 ± 28.0 | .42 |
BG <70 mg/dL, n (%) | 3 (2%) | 14 (9%) | 29 (10%) | .004 |
BG <54 mg/dL, n (%) | 1 (1%) | 2 (1%) | 2 (1%) | >.99 |
BG <40 mg/dL, n (%) | 1 (1%) | 0 (0%) | 0 (0%) | .25 |
Total insulin dose, units/day | 10 ± 8 | 26 ± 15 | 29 ± 17 | <.001 |
Glargine, units/day | 0.5 ± 2 | 21 ± 12 | 17 ± 10 | <.001 |
Rapid-acting insulin, units/day | 10 ± 8 | 5 ± 6 | 13 ± 9 | <.001 |
Patients with randomization BG <200 mg/dL | ||||
DPP4-i | DPP4-i + basal | Basal-bolus | P value | |
Mean daily BG, mg/dL | 158 ± 35 | 156 ± 34 | 156 ± 30 | .98 |
Treatment failure, n (%) | 10 (10%) | 6 (8%) | 13 (8%) | .79 |
% BG within target, 70–180 mg/dL | 74 ± 27 | 70 ± 26 | 76 ± 20 | .29 |
BG <70 mg/dL, n (%) | 2 (2%) | 8 (10%) | 18 (11%) | .018 |
BG <54 mg/dL, n (%) | 1 (1%) | 1 (1%) | 1 (1%) | 1 |
BG <40 mg/dL, n (%) | 1 (0%) | 0 (0%) | 0 (0%) | .53 |
Total insulin dose, units/day | 8 ± 6 | 22 ± 12 | 24 ± 12 | <.001 |
Glargine, units/day | 1 ± 3 | 18 ± 11 | 13 ± 8 | <.001 |
Rapid-acting insulin, units/day | 8 ± 6 | 4 ± 4 | 10 ± 8 | <.001 |
Patients with randomization BG ≥200 mg/dL | ||||
DPP4-i | DPP4-i + basal | Basal-bolus | P value | |
Mean daily BG, mg/dL | 196 ± 35 | 190 ± 44 | 193 ± 52.0 | .27 |
Treatment failure, n (%) | 14 (30%) | 18 (25%) | 26 (22%) | .54 |
% BG within target, 70–180 mg/dL | 40 ± 30 | 47 ± 31 | 47 ± 29 | .29 |
BG <70 mg/dL, n (%) | 1 (2%) | 5 (7%) | 11 (9%) | .3 |
BG <54 mg/dL, n (%) | 0 (0%) | 1 (1%) | 2 (2%) | 1 |
BG <40 mg/dL, n (%) | 0 (0%) | 0 (0%) | 0 (0%) | - |
Total insulin dose, units/day | 14 ± 9 | 30 ± 16 | 37 ± 18 | <.001 |
Glargine, units/day | 0.1 ± 0.6 | 24 ± 13 | 21 ± 11 | <.001 |
Rapid-acting insulin, units/day | 13 ± 9 | 7 ± 6 | 16 ± 10 | <.001 |
Abbreviations: BG = blood glucose; DPP4-i = dipeptidyl peptidase 4-inhibitors. Treatment failure was defined as an average daily BG >240 mg/dL, or 2 consecutive values of BG >240 mg/dL.