1Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
2Division of Endocrinology and Metabolism, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
3Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea
4Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
5Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea
6Novo Nordisk Pharma Korea Limited, Seoul, Korea
7Novo Nordisk Region Asia Pacific, Dubai, United Arab Emirates
8Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
Copyright © 2024 Korean Diabetes Association
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
CONFLICTS OF INTEREST
Hak Chul Jang has been international editorial board of the Diabetes & Metabolism Journal since 2023.
Boram Bae, Amine Dahaoui, Jin Sook Jeong, and Sungeun Jung are employees of Novo Nordisk. The other authors declare no conflict of interest with respect to the study.
AUTHOR CONTRIBUTIONS
Conception or design: S.K.
Acquisition, analysis, or interpretation of data: all authors.
Drafting the work or revising: all authors.
Final approval of the manuscript: all authors.
FUNDING
The study was funded by Novo Nordisk Pharma Korea Ltd.
Values are presented as mean±standard deviation or number (%).
T2DM, type 2 diabetes mellitus; BMI, body mass index; HbA1c, glycosylated hemoglobin; FPG, fasting plasma glucose; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol; IDegAsp, insulin degludec/insulin aspart.
Variable |
Pre-switching |
Post-switching |
P valuea,b (pre- vs. post-switching) | ||||
---|---|---|---|---|---|---|---|
Week –26 | Week 0 | P valuea | Week –26 | Week 0 | P valuea | ||
HbA1c, % | 8.50±1.31 | 8.78±1.25 | 0.002 | 8.78±1.25 | 8.27±1.17 | <0.001 | - |
Change in the 26-week period | 0.28±1.27 | - | –0.51±1.12 | - | <0.001 | ||
FPG, mg/dL | 158.03±63.98 | 163.24±65.64 | 0.369 | 163.24±65.64 | 140.15±55.37 | <0.001 | - |
Change in the 26-week period | 5.21±80.41 | - | –23.10±78.65 | - | 0.005 | ||
Proportion of achieving HbA1c <7% | 18 (9.18) | 10 (5.10) | 0.057 | 10 (5.10) | 22 (11.22) | 0.012 | - |
Proportion of achieving HbA1c <7% without any hypoglycemia | 6 (4.08) | - | 12 (8.16) | - | 0.180 | ||
Body weight, kg | 69.11±13.54 | 69.74±13.97 | 0.010 | 69.74±13.97 | 69.75±13.74 | 0.980 | - |
Change in the 26-week period | 0.63±2.84 | - | 0.01±2.36 | - | 0.113 | ||
Daily total insulin dose, U | 37.42±21.80 | 39.15±20.92 | 0.079 | 39.15±20.92 | 41.14±22.91 | 0.001 | - |
Change in the 26-week period | 1.72±13.69 | - | 1.98±8.54 | - | 0.828 | ||
Daily total insulin dose, U/kg | 0.53±0.27 | 0.56±0.28 | 0.075 | 0.56±0.28 | 0.58±0.29 | 0.024 | - |
Change in the 26-week period | 0.03±0.18 | - | 0.02±0.11 | - | 0.765 |
Variable | Pre-switching | Post-switching | P valuea |
---|---|---|---|
Overall hypoglycemic events | 34 (23.13) | 32 (21.77) | 0.860 |
Severe hypoglycemic events | 0 | 0 | NA |
Nocturnal hypoglycemic events | 6 (4.76) | 6 (4.76) | 1.000 |
Values are presented as number (%) (with ≥1 hypoglycemic events).
Nocturnal hypoglycemia was an event for which the words ‘nocturnal’ or ‘night’ or their equivalent were recorded and/or the time of the event was recorded as being between midnight and 6:00 AM.
NA, not applicable.
a McNemar’s exact test.
Values are presented as unstandardized coefficients (B) and standardized coefficient (β) using multiple regression analysis (Enter method of independent variables). Dependent variable was baseline value in HbA1c at week 0; R square (adjusted R square): 0.315 (0.279); F=8.74. This analysis was performed using multiple regression (Enter method of independent variables).
HbA1c, glycosylated hemoglobin; IDegAsp, insulin degludec/insulin aspart; BMI, body mass index; T2DM, type 2 diabetes mellitus.
Characteristic | Full analysis set (n=196) |
---|---|
Age, yr | 65.95±11.23 |
Age group, yr | |
19–64 | 85 (43.36) |
≥65 | 111 (56.63) |
Sex | |
Male | 118 (60.20) |
Female | 78 (39.80) |
Duration of T2DM, yr | 18.99±9.15 |
Duration of insulin treatment, yr | 6.13±5.36 |
BMI, kg/m2 | 25.94±4.32 |
Body weight, kg | 69.21±14.33 |
HbA1c, % | 8.78±1.25 |
FPG, mg/dL | 163.03±65.63 |
Blood pressure, mm Hg | |
Systolic blood pressure | 130.46±17.01 |
Diastolic blood pressure | 74.24±11.35 |
Lipid profile, mg/dL | |
Total cholesterol | 149.78±35.91 |
LDL-C | 84.19±27.37 |
HDL-C | 46.98±11.49 |
Triglyceride | 146.86±94.23 |
Comorbidities | |
Hyperlipidemia | 159 (81.12) |
Hypertension | 140 (71.42) |
Stroke | 18 (9.18) |
Coronary artery disease | 60 (30.61) |
Insulin treatment 26 week before IDegAsp initiation | |
Basal insulin | 105 (53.57) |
Basal insulin with prandial insulin | 20 (10.20) |
Premix insulin | 71 (36.22) |
Variable | Pre-switching |
Post-switching |
P value |
||||
---|---|---|---|---|---|---|---|
Week –26 | Week 0 | P value |
Week –26 | Week 0 | P value |
||
HbA1c, % | 8.50±1.31 | 8.78±1.25 | 0.002 | 8.78±1.25 | 8.27±1.17 | <0.001 | - |
Change in the 26-week period | 0.28±1.27 | - | –0.51±1.12 | - | <0.001 | ||
FPG, mg/dL | 158.03±63.98 | 163.24±65.64 | 0.369 | 163.24±65.64 | 140.15±55.37 | <0.001 | - |
Change in the 26-week period | 5.21±80.41 | - | –23.10±78.65 | - | 0.005 | ||
Proportion of achieving HbA1c <7% | 18 (9.18) | 10 (5.10) | 0.057 | 10 (5.10) | 22 (11.22) | 0.012 | - |
Proportion of achieving HbA1c <7% without any hypoglycemia | 6 (4.08) | - | 12 (8.16) | - | 0.180 | ||
Body weight, kg | 69.11±13.54 | 69.74±13.97 | 0.010 | 69.74±13.97 | 69.75±13.74 | 0.980 | - |
Change in the 26-week period | 0.63±2.84 | - | 0.01±2.36 | - | 0.113 | ||
Daily total insulin dose, U | 37.42±21.80 | 39.15±20.92 | 0.079 | 39.15±20.92 | 41.14±22.91 | 0.001 | - |
Change in the 26-week period | 1.72±13.69 | - | 1.98±8.54 | - | 0.828 | ||
Daily total insulin dose, U/kg | 0.53±0.27 | 0.56±0.28 | 0.075 | 0.56±0.28 | 0.58±0.29 | 0.024 | - |
Change in the 26-week period | 0.03±0.18 | - | 0.02±0.11 | - | 0.765 |
Variable | Pre-switching | Post-switching | P value |
---|---|---|---|
Overall hypoglycemic events | 34 (23.13) | 32 (21.77) | 0.860 |
Severe hypoglycemic events | 0 | 0 | NA |
Nocturnal hypoglycemic events | 6 (4.76) | 6 (4.76) | 1.000 |
Variable | Unstandardized coefficients |
Standardized coefficient |
t | P value | |
---|---|---|---|---|---|
B | SE | β | |||
Age | –0.018 | 0.009 | –0.178 | –2.037 | 0.044 |
Female sex | 0.118 | 0.173 | 0.050 | 0.683 | 0.496 |
BMI | 0.021 | 0.021 | 0.079 | 0.993 | 0.323 |
HbA1c (week 0) | –0.458 | 0.069 | –0.496 | –6.681 | <0.001 |
Duration of T2DM, yr | 0.011 | 0.011 | 0.088 | 1.001 | 0.319 |
Duration of insulin treatment, yr | 0.010 | 0.016 | 0.045 | 0.592 | 0.555 |
Insulin doses (week 0) | 0.001 | 0.004 | 0.017 | 0.209 | 0.835 |
Values are presented as mean±standard deviation or number (%). T2DM, type 2 diabetes mellitus; BMI, body mass index; HbA1c, glycosylated hemoglobin; FPG, fasting plasma glucose; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol; IDegAsp, insulin degludec/insulin aspart.
Values are presented as mean±standard deviation or number (%). HbA1c, glycosylated hemoglobin; FPG, fasting plasma glucose; U, units. Paired McNemar’s exact test.
Values are presented as number (%) (with ≥1 hypoglycemic events). Nocturnal hypoglycemia was an event for which the words ‘nocturnal’ or ‘night’ or their equivalent were recorded and/or the time of the event was recorded as being between midnight and 6:00 AM. NA, not applicable. McNemar’s exact test.
Values are presented as unstandardized coefficients (B) and standardized coefficient (β) using multiple regression analysis (Enter method of independent variables). Dependent variable was baseline value in HbA1c at week 0; HbA1c, glycosylated hemoglobin; IDegAsp, insulin degludec/insulin aspart; BMI, body mass index; T2DM, type 2 diabetes mellitus.