Table 3.
Baseline | 6 months | 12 months | 18 months | 24 months | 39 months[Link] | |
---|---|---|---|---|---|---|
N | 735 | 548 | 421 | 283 | 188 | 163 |
HbA1c (%) (±SD) | 8.18 ± 1.53 | 7.24 ± 1.45*** | 7.29 ± 1.51*** | 7.15 ± 1.29*** | 7.23 ± 1.30*** | 7.25 ± 1.33*** |
FPG (mg/dL) (±SD) | 177 ± 59 | 145 ± 51*** | 153 ± 53*** | 146 ± 47*** | 149 ± 43*** | 153 ± 52** |
BMI (kg/m2) (±SD) | 38.56 ± 6.6 | 37.05 ± 6.1** | 37.21 ± 6.8** | 36.90 ± 6.0* | 36.88 ± 5.8* | 37.01 ± 6.1* |
GI AE (%) | 13.81 | 5.57 | 2.65 | 2.45 | 2.10 | |
Withdrawal (%) | 21.58 | 15.25 | 15.47 | 12.05 | 18.06 | |
Lack of efficacy[Link] (%) | 18.31 | 19.22 | 18.01 | 12.93 | 18.57 | |
Other ADM. n (±SD) | 2.18 ± 0.99 | 1.80 ± 0.78*** | 1.77 ± 0.80*** | 1.79 ± 0.81*** | 1.74 ± 0.78*** | 1.75 ± 0.80*** |
Metformin (%) | 91.29 | 92.76 | 93.75 | 93.56 | 92.77 | 94.44 |
SU (%) | 31.46 | 29.71 | 28.25 | 30.04 | 32.53 | 32.87 |
DPP‐IV‐I (%) | 37.24 | 6.11 | 3.50 | 4.55 | 2.41 | 1.39 |
Pioglitazone (%) | 1.69 | 0.96 | 1.26 | 1.9 | 1.81 | 3.47 |
SGLT2‐I (%) | 3.79 | 6.11 | 5.76 | 6.82 | 6.63 | 11.11 |
Basal insulin (%) | 39.04 | 36.12 | 34.84 | 34.09 | 30.12 | 29.17 |
Bolus insulin (%) | 18.38 | 9.92 | 10.35 | 10.69 | 10.84 | 6.25 |
ADM, antidiabetic medications; BMI, body mass index; DPP‐IV‐I, dipeptidyl peptidase‐IV inhibitor; FPG, fasting plasma glucose; GI AE, gastrointestinal adverse events; HbA1c, Glycated haemoglobin; SD, standard deviation; SGLT2‐I, sodium‐glucose cotransporter‐2 inhibitor; SU, sulfonylurea.
Lack of efficacy defined as HbA1c reduction <0.5% and/or BMI reduction <3% after 6 months of follow‐up.
Last available hospital visit for patients with follow‐up visits beyond 24 months.
P < 0.05.
P < 0.01.
P < 0.001 vs baseline. ANCOVA test for repeated measures.