Table 2 Changes in the efficacy measures and clinical parameters during the study
Parameter | Premixed insulin (n = 22) | IDegAsp (n = 22) | Effect size of LS mean difference (95% CI) | P-value |
|---|---|---|---|---|
SD of morning fasting glucose (mg/dL) | 20.0 ± 1.9 | 19.3 ± 1.3 | − 0.09 (− 0.68, 0.50) | 0.686 |
M-value | 53.9 [24.5, 73.3] | 27.6 [13.1, 69.2] | – | 0.049 |
HbA1c (%) | 7.68 ± 0.13 | 7.50 ± 0.16 | − 0.26 (− 0.85, 0.33) | 0.066 |
Mean blood glucose (mg/dL) | 175.5 ± 5.7 | 163.0 ± 5.6 | − 0.46 (− 1.06, 0.14) | 0.004 |
Morning insulin dose (U) | 7.91 ± 0.70 | 8.05 ± 0.78 | 0.04 (− 0.55, 0.63) | 0.576 |
Evening insulin dose (U) | 8.23 ± 0.76 | 7.77 ± 0.72 | − 0.13 (− 0.72, 0.46) | 0.047 |
Hypoglycemia (episodes per month) | 0.0 [0.0, 0.0] | 0.0 [0.0, 0.0] | – | 0.688 |
Body weight (kg) | 64.2 ± 2.2 | 63.8 ± 2.1 | − 0.04 (− 0.63, 0.55) | 0.294 |
eGFR (mL/min/1.73 m2) | 61.8 ± 3.2 | 62.6 ± 3.8 | 0.05 (− 0.54, 0.64) | 0.481 |
Triglyceride (mg/dL) | 115.8 ± 14.9 | 118.2 ± 16.9 | 0.03 (− 0.56, 0.62) | 0.760 |
HDL cholesterol (mg/dL) | 53.8 ± 2.1 | 52.8 ± 2.5 | − 0.09 (− 0.68, 0.50) | 0.063 |
LDL cholesterol (mg/dL) | 92.2 ± 4.9 | 92.1 ± 5.0 | 0.00 (− 0.60, 0.59) | 0.828 |
Aspartate transaminase (IU/L) | 18.5 [17.0, 22.3] | 18.0 [17.0, 21.3] | – | 0.155 |
Alanine aminotransferase (IU/L) | 16.5 [13.0, 24.0] | 17.0 [13.8, 26.0] | – | 0.801 |
γ-glutamyl transpeptidase (IU/L) | 21.5 [17.5, 52.8] | 23.0 [16.0, 58.0] | – | 0.814 |