Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial.
Adult
Humans
Diabetes Mellitus, Type 2
/ drug therapy
Glycated Hemoglobin
Blood Glucose
Treatment Outcome
Biphasic Insulins
/ therapeutic use
Insulin Aspart
/ therapeutic use
Hypoglycemic Agents
/ therapeutic use
Hypoglycemia
/ chemically induced
Insulin Glargine
/ therapeutic use
Patient Reported Outcome Measures
GLP-1 analogue
basal insulin
glycaemic control
iGlarLixi
patient-reported outcomes
type 2 diabetes
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
12 2022
12 2022
Historique:
revised:
11
07
2022
received:
26
04
2022
accepted:
19
07
2022
pubmed:
3
9
2022
medline:
1
11
2022
entrez:
2
9
2022
Statut:
ppublish
Résumé
To assess patient-reported outcomes (PROs) in the SoliMix trial, which compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with type 2 diabetes (T2D). SoliMix (EudraCT: 2017-003370-13), a 26-week, open-label study, randomized (1:1) 887 adults with T2D and HbA1c ≥7.5%-≤10.0% (≥58-≤86 mmol/mol) on basal insulin plus oral antihyperglycaemic drugs (OADs) to once-daily iGlarLixi or twice-daily premix insulin, BIAsp 30. PROs were assessed using the Treatment-Related Impact Measure Diabetes (TRIM-D) and Global Treatment Effectiveness Evaluation (GTEE) questionnaires. Over 26 weeks, iGlarLixi showed greater improvement from baseline versus BIAsp 30 in total TRIM-D score (least squares mean difference [95% confidence interval]: 5.08 [3.69, 6.47]; effect size: 0.32) and in each TRIM-D domain, with the greatest differences seen in diabetes management (8.47 [6.11, 10.84]) and treatment burden (6.95 [4.83, 9.07]). GTEE scores showed a greater proportion of participants and physicians rated a complete or marked improvement of diabetes control with iGlarLixi (80.5%, 82.8%) versus BIAsp 30 (63.3%, 65.1%) at week 26. Post hoc analyses showed that after adjusting for HbA1c, body weight and hypoglycaemia outcomes, iGlarLixi continued to show greater improvements in TRIM-D total scores versus BIAsp 30. In addition to better glycaemic control, weight benefit and less hypoglycaemia, once-daily iGlarLixi provided improved diabetes management, treatment burden and perceived effectiveness versus twice-daily premix BIAsp 30, further supporting iGlarLixi as an advanced treatment option in people with suboptimally controlled T2D on basal insulin plus OADs.
Identifiants
pubmed: 36053820
doi: 10.1111/dom.14822
pmc: PMC9805099
doi:
Substances chimiques
insulin aspart, insulin aspart protamine drug combination 30:70
0
Glycated Hemoglobin A
0
Blood Glucose
0
Biphasic Insulins
0
Insulin Aspart
D933668QVX
Hypoglycemic Agents
0
Insulin Glargine
2ZM8CX04RZ
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2364-2372Informations de copyright
© 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
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