TY - JOUR
T1 - Degludec hospital trial
T2 - A randomized controlled trial comparing insulin degludec U100 and glargine U100 for the inpatient management of patients with type 2 diabetes
AU - Galindo, Rodolfo J.
AU - Pasquel, Francisco J.
AU - Vellanki, Priyathama
AU - Alicic, Radica
AU - Lam, David W.
AU - Fayfman, Maya
AU - Migdal, Alexandra L.
AU - Davis, Georgia M.
AU - Cardona, Saumeth
AU - Urrutia, Maria A.
AU - Perez-Guzman, Citlalli
AU - Zamudio-Coronado, Karla Walkiria
AU - Peng, Limin
AU - Tuttle, Katherine R.
AU - Umpierrez, Guillermo E.
N1 - Funding Information:
RJG is supported in part by grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institute of Health (NIH) under award numbers P30DK111024‐04S2 and 1K23DK123384‐02, outside the submitted work. RJG received unrestricted research support (to Emory University) for investigator‐initiated studies from Novo Nordisk and Dexcom, and consulting fees from Abbott Diabetes Care, Sanofi, Novo Nordisk, Eli Lilly and Valeritas, outside the submitted work. PV is supported in part by National Institute of Health grant 1K23DK113241 and has received consulting fees from Merck and Boehringer‐Ingelheim. FP reports grants from Merck and Dexcom, consultant/advisory fees from Merck, Astra Zeneca, Lilly, Boheringer Ingelheim, and Sanofi. FJP is supported by grants from National Institutes of Health (grant P30‐DK‐111024) from NIDDK, and from National Institutes of Health (grant 1K23GM128221‐01A1) from the National Institute of General Medical Sciences, outside the submitted work. GMD is supported NIH under award number 1K23DK122199‐01A1, and received research support for studies (to Emory University) from Insulet Corp, outside the submitted work. MF is supported NIH/NIDDK under award number 1K23‐124647A. RA has received consulting fees from Boehringer Ingelheim, outside the submitted work. KRT is supported by research grants from NIH/NCATS 4UL1TR00426‐10 and NIH/NIDDK 1U2CDK114886‐01, 5UM1DK100846‐03, 2U01DK10086‐07, 1U54DK083912, 2UC4DK101108‐02, and CDC grant 75D301‐19‐Q‐69877, and has served as a consultant for Eli Lilly and Company, Boehringer Ingelheim, Astra Zeneca, Gilead, Goldfinch Bio, Novo Nordisk, Bayer, and Janssen. GEU is partly supported by research grants from the NIH/NATS UL1 TR002378 from the Clinical and Translational Science Award program, and NIH/NIDDK 1P30DK111024‐01 from NIH and National Center for Research Resources. GEU has received unrestricted research support for research studies (to Emory University) from Novo Nordisk, Astra Zeneca and Dexcom Inc. All other authors declare that they have no competing interests.
Publisher Copyright:
© 2021 John Wiley & Sons Ltd.
PY - 2022/1
Y1 - 2022/1
N2 - Aims: Limited data exist about the use of insulin degludec in the hospital. This multicentre, non-inferiority, open-label, prospective randomized trial compared the safety and efficacy of insulin degludec-U100 and glargine-U100 for the management of hospitalized patients with type 2 diabetes. Methods: In total, 180 general medical and surgical patients with an admission blood glucose (BG) between 7.8 and 22.2 mmol/L, treated with oral agents or insulin before hospitalization were randomly allocated (1:1) to a basal-bolus regimen using degludec (n = 92) or glargine (n = 88), as basal and aspart before meals. Insulin dose was adjusted daily to a target BG between 3.9 and 10.0 mmol/L. The primary endpoint was the difference in mean hospital daily BG between groups. Results: Overall, the randomization BG was 12.2 ± 2.9 mmol/L and glycated haemoglobin 84 mmol/mol (9.8% ± 2.0%). There were no differences in mean daily BG (10.0 ± 2.1 vs. 10.0 ± 2.5 mmol/L, p =.9), proportion of BG in target range (54·5% ± 29% vs. 55·3% ± 28%, p =.85), basal insulin (29.6 ± 13 vs. 30.4 ± 18 units/day, p =.85), length of stay [median (IQR): 6.7 (4.7-10.5) vs. 7.5 (4.7-11.6) days, p =.61], hospital complications (23% vs. 23%, p =.95) between treatment groups. There were no differences in the proportion of patients with BG <3.9 mmol/L (17% vs. 19%, p =.75) or <3.0 mmol/L (3.7% vs. 1.3%, p =.62) between degludec and glargine. Conclusion: Hospital treatment with degludec-U100 or glargine-U100 is equally safe and effective for the management of hyperglycaemia in general medical and surgical patients with type 2 diabetes.
AB - Aims: Limited data exist about the use of insulin degludec in the hospital. This multicentre, non-inferiority, open-label, prospective randomized trial compared the safety and efficacy of insulin degludec-U100 and glargine-U100 for the management of hospitalized patients with type 2 diabetes. Methods: In total, 180 general medical and surgical patients with an admission blood glucose (BG) between 7.8 and 22.2 mmol/L, treated with oral agents or insulin before hospitalization were randomly allocated (1:1) to a basal-bolus regimen using degludec (n = 92) or glargine (n = 88), as basal and aspart before meals. Insulin dose was adjusted daily to a target BG between 3.9 and 10.0 mmol/L. The primary endpoint was the difference in mean hospital daily BG between groups. Results: Overall, the randomization BG was 12.2 ± 2.9 mmol/L and glycated haemoglobin 84 mmol/mol (9.8% ± 2.0%). There were no differences in mean daily BG (10.0 ± 2.1 vs. 10.0 ± 2.5 mmol/L, p =.9), proportion of BG in target range (54·5% ± 29% vs. 55·3% ± 28%, p =.85), basal insulin (29.6 ± 13 vs. 30.4 ± 18 units/day, p =.85), length of stay [median (IQR): 6.7 (4.7-10.5) vs. 7.5 (4.7-11.6) days, p =.61], hospital complications (23% vs. 23%, p =.95) between treatment groups. There were no differences in the proportion of patients with BG <3.9 mmol/L (17% vs. 19%, p =.75) or <3.0 mmol/L (3.7% vs. 1.3%, p =.62) between degludec and glargine. Conclusion: Hospital treatment with degludec-U100 or glargine-U100 is equally safe and effective for the management of hyperglycaemia in general medical and surgical patients with type 2 diabetes.
KW - degludec
KW - glargine
KW - hospital care
KW - hypoglycaemia
KW - inpatient management
UR - http://www.scopus.com/inward/record.url?scp=85115370816&partnerID=8YFLogxK
U2 - 10.1111/dom.14544
DO - 10.1111/dom.14544
M3 - Article
C2 - 34490700
AN - SCOPUS:85115370816
SN - 1462-8902
VL - 24
SP - 42
EP - 49
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
IS - 1
ER -