RT Journal Article
T1 Efficacy and safety of basal insulin degludec 100 IU/mL versus glargine 300 IU/mL for type 1 diabetes: the single-center INEOX randomized controlled trial.
A1 Ruiz de Adana Navas, María Soledad
A1 Domínguez, Marta Elena
A1 Morillas, Virginia
A1 Colomo, Natalia
A1 Vallejo Mora, María del Rosario
A1 Guerrero, Mercedes
A1 García-Escobar, Eva
A1 Carreira-Soler, Mónica
A1 Romero-Zerbo, Silvana Yanina
A1 Linares, Francisca
A1 González-Mariscal, Isabel
A1 Bermúdez Silva, Francisco Javier
A1 Olveira-Fuster, Gabriel María
A1 Rojo-Martínez, Gemma
K1 Diabetes - Tratamiento
AB AimsTo compare efficacy and safety of degludec 100 IU/mL (Deg-100) and glargine 300 IU/mL (Gla-300) in adults with type 1 diabetes.MethodsOpen-label, single-center, randomized, parallel-group, 24-week trial in adults with type 1 diabetes, on basal-bolus insulin therapy, HbA1c ≤ 10%, using self-monitoring blood glucose. Participants were randomized 1:1 to a basal-bolus insulin regimen with Deg-100 (N = 129) or Gla-300 (N = 131). Primary efficacy endpoint: mean change in HbA1c from baseline to week-24. Main safety outcome: incidence rate of hypoglycemia during the study. Quality of life (DQOL) and satisfaction with diabetes treatment (DTSQ) were assessed.ResultsAt week 24, after adjusting for baseline HbA1c, the decrease in HbA1c did not differ between groups: Deg-100 (−0.07 ± 0.7%) and Gla-300 (−0.16 ± 0.77%) (P = 0.320). There were no significant differences between groups in HbA1c, nocturnal hypoglycemia, severe hypoglycemia, DQOL, or DTSQ scores. The incidence rates of hypoglycemia < 3.9 mmol/L (Deg-100: 115.24 events/person-year vs Gla-300: 99.01 events/person-year, p < 0.001); and < 3.0 mmol/L (Deg-100: 41.17 events/person-year vs Gla-300: 34.29 events/person-year, p < 0.001) were different between groups.ConclusionsDeg-100 and Gla-300 have similar metabolic efficacy, incidence ratio of nocturnal and severe hypoglycemia, DQOL and DTSQ scores. Differences in the incidence rate of hypoglycemia < 3.9 mmol/L and < 3.0 mmol/L should be confirmed.
PB Elsevier
YR 2023
FD 2023
LK https://hdl.handle.net/10630/37256
UL https://hdl.handle.net/10630/37256
LA eng
NO María Soledad Ruiz de Adana, Marta Elena Domínguez, Virginia Morillas, Natalia Colomo, Rosario Vallejo-Mora, Mercedes Guerrero, Eva García-Escobar, Mónica Carreira, Yanina Romero-Zerbo, Francisca Linares, Isabel González-Mariscal, Francisco Javier Bermúdez-Silva, Gabriel Olveira, Gemma Rojo-Martínez, Efficacy and safety of basal insulin degludec 100 IU/mL versus glargine 300 IU/mL for type 1 diabetes: The single-center INEOX randomized controlled trial, Diabetes Research and Clinical Practice, Volume 196, 2023, 110238, ISSN 0168-8227, https://doi.org/10.1016/j.diabres.2023.110238
NO This work was supported by the Instituto de Salud Carlos III (grant number PI 17/00861).
DS RIUMA. Repositorio Institucional de la Universidad de Málaga
RD 21 ene 2026