@article{3078546,
    title = "IDegLira improves patient-reported outcomes while using a simple regimen with fewer injections and dose adjustments compared with basal–bolus therapy",
    author = "Miller, E. and Doshi, A. and Grøn, R. and Jódar, E. and Őrsy, P. and Ranthe, M.F. and Sugimoto, D. and Tentolouris, N. and Viljoen, A. and Billings, L.K.",
    journal = "Diabetes, Obesity and Metabolism",
    year = "2019",
    volume = "21",
    number = "12",
    pages = "2643-2650",
    publisher = "Wiley-Blackwell Publishing Ltd",
    issn = "1462-8902, 1463-1326",
    doi = "10.1111/dom.13851",
    keywords = "hemoglobin A1c;  insulin aspart;  insulin degludec plus liraglutide;  insulin glargine;  metformin;  antidiabetic agent;  insulin degludec plus liraglutide;  liraglutide;  long acting insulin, adult;  Article;  bolus injection;  clinical evaluation;  clinical practice;  controlled study;  disease burden;  dose response;  functional status assessment;  glycemic control;  hemoglobin blood level;  human;  hypoglycemia;  major clinical study;  medication compliance;  mental health;  monotherapy;  non insulin dependent diabetes mellitus;  open study;  patient compliance;  patient-reported outcome;  post hoc analysis;  randomized controlled trial (topic);  Short Form 36;  Treatment Related Impact Measure Diabetes;  clinical trial;  drug combination;  injection;  multicenter study;  non insulin dependent diabetes mellitus;  patient-reported outcome;  randomized controlled trial, Diabetes Mellitus, Type 2;  Drug Combinations;  Humans;  Hypoglycemic Agents;  Injections;  Insulin, Long-Acting;  Liraglutide;  Patient Reported Outcome Measures",
    abstract = "Aims: Basal–bolus therapy is associated with greater treatment burden and lower adherence compared with more simplified regimens. This post hoc analysis studied the difference between insulin degludec/liraglutide (IDegLira) and basal–bolus therapy on number of injections, dose adjustments and patient outcomes in the DUAL VII trial. Materials and methods: DUAL VII was a 26-week, open-label trial in which patients with uncontrolled type 2 diabetes who were using metformin and insulin glargine 100 units/mL (20–50 U) were randomized 1:1 to IDegLira (N = 252) or basal–bolus (insulin glargine U100 + insulin aspart ≤4 times/day) (N = 254). This post hoc analysis reports the observed mean number of injections and cumulative dose adjustments during 26 weeks of treatment. Patient-reported outcomes (Treatment-Related Impact Measure – Diabetes [TRIM-D] and Short Form-36 Health Survey version 2 [SF-36v2]) were collected at scheduled visits and change from baseline scores calculated. Results: The clinical benefits (non-inferior HbA1c reductions, weight benefit, less hypoglycaemia) of IDegLira vs basal–bolus therapy were achieved with fewer cumulative dose adjustments (16.6 vs 217.2, respectively) and fewer injections (1 vs ≥3 per day, respectively). Patients treated with IDegLira experienced significant improvements across all TRIM-D domains compared with those undergoing basal–bolus therapy. The SF-36v2 showed improvements in both treatment arms with no significant difference between arms in the physical component summary, but there was a significant improvement in patients treated with IDegLira in the mental component summary (P =.0228). Conclusions: These findings, combined with the DUAL VII results, suggest that IDegLira, through a more simplified regimen versus basal–bolus therapy, may help improve patient adherence and improve patient outcomes related to diabetes management, treatment burden and mental health, which in turn may assist in the timely achievement of glycaemic control in clinical practice. © 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd."
}