Efficacy and Safety of Once-Daily Insulin Degludec/Insulin Aspart versus Insulin Glargine (U100) for 52 Weeks in Insulin-Naïve Patients with Type 2 Diabetes : A Randomized Controlled Trial
Kumar, Ajay (Diabetes Care & Research Centre (Índia))
Franek, Edward (Polish Academy of Sciences)
Wise, Jonathan (Tulane Medical School)
Niemeyer, Marcus (Market Access and Public Affairs, Novo Nordisk Pharma (Alemanya))
Mersebach, Henriette (Clinical Development & Research-Diabetes & Novo Nordisk (Estats Units d'Amèrica))
Simó Canonge, Rafael (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Universitat Autònoma de Barcelona

Date:	2016
Abstract:	The efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily (OD) compared with insulin glargine U100 (IGlar) OD over 52 weeks in insulin-naïve adults with type 2 diabetes mellitus (T2DM) was investigated. In this open-label, parallel-group treat-to-target trial, participants were randomized (1:1) to receive IDegAsp OD (breakfast, n = 266) or IGlar OD (as per label, n = 264). Participants then entered a 26-week extension phase (IDegAsp OD, n = 192; IGlar OD, n = 221). The primary endpoint was change from baseline to Week 26 in HbA. After 26 and 52 weeks, mean HbA decreased to similar levels in both groups. After 52 weeks, the mean estimated treatment difference was -0. 08% (-0. 26, 0. 09 95%CI), confirming the non-inferiority of IDegAsp OD versus IGlar OD evaluated at Week 26. After 52 weeks, there was a similar reduction in mean fasting plasma glucose in both treatment groups. The rate of confirmed hypoglycemic episodes was 86% higher (p < 0. 0001) whereas the rate of nocturnal hypoglycemia was 75% lower (p < 0. 0001) for IDegAsp versus IGlar. Nocturnal-confirmed hypoglycemia was higher with IGlar whereas overall and diurnal hypoglycemia were higher with IDegAsp dosed at breakfast. These results highlight the importance of administration of IDegAsp with the main meal of the day, tailored to the individual patient's.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	PloS one, Vol. 11 (october 2016) , ISSN 1932-6203

DOI: 10.1371/journal.pone.0163350
PMID: 27760129

14 p, 1.5 MB

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