Fig. 1Changes in hemoglobin A1c (HbA1c) levels and the insulin dose before and after the replacement of basal insulin with once-daily insulin degludec/insulin aspart (IDegAsp). (A) Changes up to 3 months after the replacement of basal insulin with once-daily IDegAsp. (B) Changes up to 6 months after the replacement of basal insulin with once-daily IDegAsp (n=35). a,bP<0.05 vs. baseline by post hoc analyses (the Bonferroni multiple comparison test and the Dunn multiple comparison test).
Table 1Clinical Characteristics of Participants According to Baseline Gap-FPG
Variable |
Total participants (n=80) |
Gap-FPG |
P valuea
|
<–20 mg/dL (n=26) |
≥–20 and <20 mg/dL (n=32) |
≥20 mg/dL (n=22) |
Male sex |
42 (52.5) |
12 (46.2) |
15 (46.9) |
15 (68.2) |
0.224 |
Age, yr |
67.0±9.8 |
65.4±11.4 |
66.9±9.80 |
69.2±7.5 |
0.402 |
BMI, kg/m2
|
24.5±3.8 (n=70) |
24.7±4.7 (n=23) |
25.0±3.7 (n=26) |
23.7±2.8 (n=21) |
0.501 |
Duration of diabetes, yr |
18.9±8.5 (n=69) |
18.8±7.8 (n=25) |
17.9±8.0 (n=28) |
20.8±10.4 (n=16) |
0.560 |
HbA1c, % |
8.7±1.0 |
8.7±0.8 |
8.6±0.9 |
8.8±1.3 |
0.878 |
FPG, mg/dL |
124.8±41.5 |
87.0±11.3 |
120.4±18.1 |
175.7±36.5 |
<0.001 |
Gap-FPG, mg/dL |
0.0±38.9 |
−37.8±13.1 |
−3.5±12.9 |
49.8±29.4 |
NA |
Fasting C-peptide, ng/mL |
1.63±1.37 (n=61) |
1.75±2.00 (n=20) |
1.35±0.81 (n=23) |
1.86±1.04 (n=18) |
0.451 |
Insulin dose, IU |
23.4±10.7 |
21.1±8.5 |
25.6±11.8 |
22.7±11.0 |
0.263 |
Insulin dose, IU/kg |
0.36±0.14 (n=70) |
0.33±0.12 (n=23) |
0.37±0.14 (n=26) |
0.37±0.16 (n=21) |
0.585 |
Total cholesterol, mg/dL |
143.8±35.1 |
141.0±29.4 |
147.4±43.6 |
141.7±27.7 |
0.757 |
eGFR, mL/min/1.73 m2
|
73.3±31.5 |
71.4±33.4 |
81.5±28.0 |
63.6±32.4 |
0.113 |
Retinopathy |
49 (61.3) |
17 (65.4) |
20 (65.5) |
12 (54.5) |
0.732 |
Basal insulin |
|
|
|
|
|
Glargine U-100 |
40 (50.0) |
13 (50.0) |
15 (46.9) |
12 (54.5) |
|
Degludec |
23 (28.8) |
7 (26.9) |
11 (34.4) |
5 (22.7) |
|
Glargine U-300, detemir |
17 (21.3) |
6 (23.1) |
6 (18.8) |
5 (22.7) |
0.914 |
OAD |
|
|
|
|
|
Metformin |
65 (81.3) |
22 (84.6) |
27 (84.4) |
16 (72.7) |
0.485 |
DPP4 inhibitors |
44 (55.0) |
15 (57.7) |
18 (56.3) |
11 (50.0) |
0.853 |
Sulfonylurea |
39 (48.8) |
12 (46.2) |
16 (50.0) |
11 (50.0) |
0.949 |
Others |
8 (10.0) |
2 (7.7) |
2 (6.3) |
4 (18.2) |
0.318 |
Other medications |
|
|
|
|
|
Hypertension |
53 (66.3) |
15 (57.7) |
22 (68.8) |
16 (72.7) |
0.508 |
Dyslipidemia |
65 (81.3) |
21 (80.8) |
27 (84.4) |
17 (77.3) |
0.804 |
Table 2Comparison of Insulin Doses and HbA1c Levels before and after the Change to Once-Daily IDegAsp from Basal Insulin According to Gap-FPG
Variable |
−3 mo |
Baseline |
3 mo |
P valuea
|
Low (gap-FPG <–20 mg/dL) |
|
|
|
|
Insulin, IU/kg |
0.32±0.12 |
0.33±0.12 |
0.35±0.11 |
0.001 |
HbA1c, % |
8.3±0.9b
|
8.7±0.8 |
8.3±0.9b
|
0.021 |
Intermediate (–20≤ gap-FPG <20 mg/dL) |
|
|
|
|
Insulin, IU/kg |
0.34±0.13b
|
0.37±0.14 |
0.39±0.16b
|
<0.001 |
HbA1c, % |
8.4±0.8 |
8.6±0.9 |
8.2±1.0b
|
0.018 |
High (gap-FPG ≥20 mg/dL) |
|
|
|
|
Insulin, IU/kg |
0.35±0.15 |
0.37±0.16 |
0.41±0.17b
|
0.002 |
HbA1c, % |
8.6±1.3 |
8.8±1.3 |
8.3±1.5 |
0.059 |
Table 3Comparison of Insulin Doses and HbA1c Levels before and after the Change to Once-Daily IDegAsp from Basal Insulin According to Insulin Reservoir
Variable |
−3 mo |
Baseline |
3 mo |
P valuea
|
According to fasting C-peptide levels, ng/mL |
|
|
|
|
C-peptide <0.7 (n=17) |
|
|
|
|
Insulin, IU/kg |
0.38±0.15 |
0.39±0.15 |
0.41±0.14 |
0.019 |
HbA1c (%) |
8.5 (7.1–10.6) |
8.9 (7.1–10.2) |
8.4 (5.6–10.6)b
|
0.057 |
C-peptide ≥0.7 and <1.8 (n=15) |
|
|
|
|
Insulin, IU/kg |
0.36±0.11b
|
0.39±0.11 |
0.43±0.12b
|
0.000 |
HbA1c, % |
8.4±0.9 |
8.8±0.9 |
8.1±0.7b
|
0.003 |
C-peptide ≥1.8 (n=22) |
|
|
|
|
Insulin, IU/kg |
0.37±0.13 |
0.39±0.14 |
0.44±0.16b
|
0.001 |
HbA1c, % |
8.7±0.9 |
8.7±0.9 |
8.7±1.1 |
0.871 |
According to insulin dose, IU/kg |
|
|
|
|
Insulin dose >0.52 (n=11) |
|
|
|
|
Insulin, IU/kg |
0.54±0.07b
|
0.57±0.06 |
0.59±0.06 |
0.020 |
HbA1c, % |
9.4 (7.8–10.1) |
9.1 (7.8–9.9) |
8.6 (7.3–10.2)b
|
0.028 |
Insulin dose >0.35 and ≤0.52 (n=19) |
|
|
|
|
Insulin, IU/kg |
0.38±0.07b
|
0.43±0.05 |
0.48±0.08b |
0.000 |
HbA1c, % |
8.8±1.0 |
9.1±1.0 |
8.5±1.2b
|
0.022 |
Insulin dose ≤0.35 (n=26) |
|
|
|
|
Insulin, IU/kg |
0.25±0.07 |
0.25±0.06 |
0.28±0.07b
|
0.000 |
HbA1c, % |
8.3±0.9 |
8.5±0.8 |
8.4±1.2 |
0.510 |